Peyronies Society Forums

Look everybody, Xiaflex has its own thread :). Time will tell if it actually deserves it. I found this today. It relates to use in DC, but presses the point that it's VERY important once/if this stuff is eventually available to us all, to get the right guy injecting it..

QuoteAuxilium's (NASDAQ:AUXL) Xiaflex FDA Advisory Panel will likely be focused on a surgeon education and training program that will be in place to limit side effects from improper use, such as tendon rupture and digital nerve damage, hand surgeons told Pharmawire.

The FDA's Arthritis Advisory Committee will tentatively review Xiaflex on 16 September 2009. The FDA advisory committee is looking at including hand and/or orthopedic surgeons on the panel, but the breakdown has not been revealed, according to Will Sargent, vice president of investor relations and corporate communications at Auxilium.

Regardless of the FDA pathway, Auxilium believes that educating the surgeon base about the proper technique for injecting Xiaflex is important, Sargent said. The company is planning a "robust" education program that it plans to share with the FDA, and is in a dialogue now, he said. The education program would ensure that surgeons are aware of the risk/benefit profile and are aware of what worked best in clinical testing, he added.

Dr Srinath Kamineni, a consultant orthopedic surgeon and elbow, shoulder, hand and wrist specialist in London, said that extensive training is needed - citing the potential risks of tendon rupture and nerve damage with injections. Tendon rupture is a huge concern because if Xiaflex is injected in the wrong place, it could lead to tendon breakdown, he said.

In the CORD I and II studies, the open-label JOINT I and II studies and the pharmacokinetics study, there were a total of three confirmed tendon ruptures (rate per injection = 0.14%); one reported tendon rupture remains unconfirmed (rate per injection = 0.05%).

The rate of tendon rupture is probably acceptable, according to Dr Roy Kulick, associate professor of orthopedic surgery at Albert Einstein School of Medicine and director of orthopedic hand surgery at Montefiore Medical Center in New York. If the cord is on top of a tendon, ruptures could occur if the injections are deep but they do not happen often, he said.

Tendon rupture is a major concern, said Dr Robert Szabo, professor of orthopedic and plastic surgery at the UC Davis School of Medicine. The clinical trials have been performed by surgeons who are more familiar with the disease so the results are better than they will be once Xiaflex is available to the public. The concern is that Xiaflex will have to be limited to surgeons, he said. If it is marketed to everyone, there will be a lot of problems, he added.

It is really a question of training, said Dr Larry Hurst, chief of hand surgery and chair of the department of orthopedics of the Health Science Center at the State University of New York at Stony Brook, and primary investigator of the CORD trials, noting that certain trials in Australia were done by rheumatologists.

The rate of tendon rupture was reasonable, said Dr Roy Meals, a clinical professor of orthopedic surgery at the University of California, Los Angeles, and an investigator for Xiaflex. Tendon rupture is partly technique dependent, he said. Education will probably start in hand surgery, where surgeons will be taught the potential risks and benefits of Xiaflex so they can use it safely, he said.

Xiaflex should be approved but with some reservation about widespread use, noted Dr William Townley, a plastic surgeon at Salsbury District Hospital in the UK. The agent will probably have the best safety if given by qualified hand/plastic surgeons with the appropriate anatomical knowledge, experience and ability to deal with complications, as well as awareness of surgical alternatives, he said.

The technique should be relatively easy to pick up, but the company will need to tell doctors to learn it well or else might Xiaflex may cause tendon rupture, said Dr F. Thomas Kaplan, a surgeon at the Indiana Hand Center.

Meals said many physicians hope that Auxilium will restrict the distribution of Xiaflex to prevent rheumatologists and dermatologists from using it because there would probably be more tendon ruptures if they did. These specialties have not seen the cord of tissue that causes the contracture and do not have a good spatial understanding of the hand, he said. "It is a scary thought," he added.

However, the severity of the rupture depends on which tendon is affected since some patients would not even know that a tendon ruptured if it did not disrupt motion, Meals said, noting that these patients already have limited motion from the contracture and that if Xiaflex brings the contracture towards normal a tendon rupture is much less of a consequence.

Yet a surgeon who spoke on the condition of anonymity said that since some authors are reporting tendon ruptures, he believed that "the nails are in its coffin." Fasciectomy or fasciotomy seem much safer, he added. The surgeon was not aware of any cases of neurolysis, but said that the occurrence is feasible.

Dr Bing Siang Gan, a surgeon at the Hand and Upper Limb Centre at the University of Western Ontario, agreed that any tendon rupture is one too many.

With nerve damage, the risk becomes higher as one injects distally, similar to traditional surgery, Kamineni explained. In over 1000 patients and over 700 injections, there was no nerve damage, Hurst said. Kaplan also described nerve injury as surprisingly low and added that no one reported temporary numbness.

However, in Dupuytren's, nothing is standard and predictable and while the cord can be palpated, it is not possible to feel the nerves so a physician would know where to inject but would not know where not to inject, Szabo cautioned.

There are different forms of collagen and some are resistant to collagenase, Meals said when asked about the potential for neurolysis. Some patients have experienced skin lacerations with Xiaflex, he noted.

One plastic surgeon noted that improper injection could result in serious consequences. If improperly injected into a digital artery, patients can lose a finger since Xiaflex works through dissolution, he said. He also noted that accidents may result in skin loss.

Vessel rupture is also a concern since many vessels are covered in collagen, said Kamineni, who explained that this could result in hematomas. There is a potential complication of hitting normal tissue with Xiaflex that is depends on on how and how often it is given, said Dr Scott Zashin, a rheumatologist and clinical associate professor of medicine at the University of Texas, Southwestern Medical School.

According to Sargent, while nerve damage appeared to be an issue in vitro, Xiaflex does not appear to affect the nerve, large arteries, or veins.

Kamineni said that lack of proper training is the "quickest way to go wrong" for the company but believed that Xiaflex genuinely has a place in treating Dupuytren's contracture.

Physicians are optimistic about approval, but there is a concern that problems may emerge if patients who do not need Xiaflex get treated with it due to the convenience of administration, Szabo said.

Meals agreed that hand surgeons were enthusiastic over the potential for Xiaflex, but noted that many adverse effects are often identified after an agent comes to market. However, he said that Xiaflex seems remarkably safe.

- http://www.ft.com/cms/s/2/aba2b8f0-7aee-11de-8c34-00144feabdc0,dwp_uuid=e8477cc4-c820-11db-b0dc-000b5df10621.html

I think the board moderator here should split out all the xiafles posts from the migrated topic into one topic.

Who is up to being that person?

The problem is that I think the vast majority or those 1000 posts ARE on the topic of Xiaflex.  The 1000 post topic almost is a xiaflex topics.  My guess if you took out every post with Xiaflex, Auxillium, AA4500, that only about 100 post would remain.

Hmm, a difficult one. Having its own thread would ensure a present and future uninterrupted flow of discussion. Should Xiaflex be solely discussed in the developmental drugs thread then we could lose the fluidity of discussion should other treatments be mentioned. Still, as you say, most of the posts are about xiaflex. Maybe the essential xiaflex posts could be included in the xiaflex thread , rather than all of them (patient experiences, studies, company statements).

If we do decide to split all xiaflex posts from the current thread, would it be better to remove all non xiaflex posts from the existing 'Developmental drugs & treatments - Still in trial or not approved for Peyronies' thread? As there are far fewer non xiaflex posts, it'd just take a bit of thread renaming once the changes had been complete.

I think we should just keep it under developmental drugs and treatments, I've actually been disappointed with the amount of people posting who are in the trials, I thought there would be many more.  I don't think it really clogs up that topic, as it is the main thing we talk about in that topic really.  If you start splitting topics like crazy the discussion will lack in each topic. The only thing I could see that would make sense was a "Post here if your in or were in xiaflex trials" topic so guys can state what they are being given and we can ask them questions.  However, again, we really don't have enough guys for this in my opinion.

Comebackid

Quote from: ComeBacKid on August 31, 2009, 03:50:45 AM
I think we should just keep it under developmental drugs and treatments, I've actually been disappointed with the amount of people posting who are in the trials, I thought there would be many more.  I don't think it really clogs up that topic, as it is the main thing we talk about in that topic really. 

I agree, it's somewhat disappointing we don't get more feedback from those in the studies. It really would be helpful to the community. As for the other point, as my suggestion doesn't appear to be very popular maybe we should go with the path of least resistence for now then, and remove this thread. If Xiaflex becomes an actual widely used treatment at some point, then we can start a brand new thread/board elsewhere from that point anyway (since it will no longer be a developmental drug) and the older posts won't be as relevant.

I agree that feed back is interesting chit chat but feedback on this study is of little value, possibly NO value in telling us anything about the effectiveness of the drug.  It may actually be WORSE than being of NO value. There is nothing of scientific worth from a bunch of people that have no clue what they were getting, trying to objectively report results.  Unless they know what they are getting, AND unless we are getting reports from ALL participants the value is at best negligible.  It is even likely worse than negligible and might well result in totally misleading conclusions.

Say 25 people post their results, 8 feel they see some improvement, 2 say they see definite improvement, 10 see no change and 5 say they think they have actually gotten worse.  What can you conclude?  Answer - anything you damn well choose to conclude.  Now factor in that there are a 100 participants that you are not hearing from.  They could all have improved, or all of them could have gotten worse, or any mix.

Frankly one of the most disappointing aspects of the PDS is our total failure of getting even members to move beyond non-scientific, irrational conclusions, based on data that is impossible to assess such as this information and anecdotal experiences.  We are still operating in the realm of a rabbit's foot and throwing a pinch of salt over our shoulder.

Finally, if 100 people began swapping data here on the trial it would stand to jeopardize the entire trial we have waited for so long.  We could not do one iota differently EVEN IF WE COULD ASSESS THE RESULTS.

Wait for the clinical assessment.

Quote from: Hawk on August 31, 2009, 10:42:47 AM
I agree that feed back is interesting chit chat but feedback on this study is of little value, possibly NO value. It may actually be WORSE than NO value.

I agree completely with the above statement. 

I believe ANY preliminary suppositions from others regarding the Xiaflex trials based on alleged participant postings are irrelevant and harmful.

Additionally, I believe that alleged participant's posts are also irrelevant and harmful to the extent that the poster provides any information other than that they are participating.

CF

 I agree that it is tough to assess the feedback when people don't know what they are getting.  However if just two people came on here and said I had a bad bend beforehand and now its completely cured, that would be something worth noting.  At this point all we have is the video from the woman who had her finger cured.  Nothing is scientific at this point, sometimes I wonder if the studies done by the urologists are even scientific, especially the one done by Dr. Levine on the VED and Verapamil Injections.  I also remember a time when a bunch of clowns in texas claimed they had a specially patented delivery system for topical verapamil that was moving through FDA approval process.  They claimed high success rates on treating peyronies.  J and I did a report on this that raised significant questions, I don't really believe much of anything I read anymore...  A little positive feedback however, would be nice to hear from trial participants!  Someone is getting the real drug somewhere... I sure hope it is working...

Comebackid

Quote from: ComeBacKid on August 31, 2009, 10:39:56 PM
Nothing is scientific at this point, sometimes I wonder if the studies done by the urologists are even scientific, especially the one done by Dr. Levine on the VED and Verapamil Injections. 
Comebackid

What study did Levine do on VED's? I'm not aware of any.

Quote from: ComeBacKid on August 31, 2009, 10:39:56 PM
I agree that it is tough to assess the feedback when people don't know what they are getting. 

Actually it is impossible to assess.  Consider that even after knowing what the participants got it takes a considerable length of time to come up with conclusions.  Even if 2 people said the went from severe bend to straight, knowing the very conservative trial approach they are using you would have to wonder if it was the needle or rare spontaneous reversal.  In addition you still would not know if 2 got better, 150 remained the same and 50 got worse.

Face it!  The Information is not of ANY value to us in a sporadic, unscientific, blind form.

Impossible to assess, but also - impossible to suppress.  That's what the internet has done for us - or to us:  eliminated the filtering and context-providing that used to be done by journalists.  Now,  participants in a trial can broadcast their results to the world the same day.  The doctors and drug companies won't like it, and will wish they could screen and edit those posts, or add explanations and corrections - but they can't.  People just have to learn to think critically and evaluate evidence on their own.   And yes I'm pessimistic about the chances of that happening.

A friend and fellow software writer once said that we're now in the Age of Information - which hopefully will be followed by the Age of Correct Information.

What makes this increasingly difficult, is the fact that even once they publish the results, assuming we withold judgement, each and every case of peyronies seems different, for example, many men complain of a lump and a bend, but my entire penis appears to be hard, like a cast around it. 

Does anyone know when the estimated publishing will be for these studies, so we can finally see if this drug is effective or not?  I believe this drug was being tested by a previous company for some 10 years where they did nothing with it... 

Comebackid

Quote from: ComeBacKid on September 02, 2009, 02:19:23 AM
What makes this increasingly difficult, is the fact that even once they publish the results, assuming we withold judgement, each and every case of peyronies seems different...

Comebackid

Yes.  With Dupuytren's it's simple - the finger either straightens or it doesn't. Diagnosis and measurement are straightforward. With Peyronie's it's hard to separate the effect of the fibrosis from many other factors affecting sexual function. So how can Xiaflex really be evaluated accurately unless the extent of the fibrosis is identified by some sort of imaging or tissue analysis?

Does anyone know if "Xiaflex" has been approved for use in Europe?

To try and answer some of your questions. I was in the study and was told that the Peyronies results will be make available in the 4th quarter of this year.  Other than that I don't know any more than you.

Xiaflex is not yet available in Europe. Everyone is waiting for the FDA to rule on Xiaflex for DC. The ruling should come shortly.  The recent article in the NEJM is promising for the approval in the case of DC, but who really knows how the FDA will rule.

The most important way to determine if Xiaflex works for Peyronies is to measure the curvature.  I had a number of penile ultrasounds and the urologist said they look different after the injections. This means nothing.  The only objective way to measure results is to measure the curvature of an erect penis.

Xiaflex was tested a number of years earlier, but the original company had financial problems and was unable to move forward.

Lets hope your right on the results being published in the fourth quarter and we get an early christmas present!

Comebackid

Sep 16, 2009   U.S. Food and Drug Administration's Arthritis Advisory Committee Votes Unanimously 12-0 to Recommend Approval of XIAFLEX(TM) for Dupuytren's Contracture.

I just took this off their web site. Does anyone know how long it might take to get the full FDA approval and then how long to go to market with the drug?

Here's the press release:

http://topnews.us/content/27157-fda-panel-backs-orphan-drug-clenched-fingers

- George

"The company is also studying Xiaflex for the penile disorder Peyronie's disease and frozen shoulder syndrome. Anido said the company does not expect to seek FDA approval for Peyronie's disease until at least 2011, and the shoulder indication possibly after that"

http://www.reuters.com/article/rbssPharmaceuticals%20-%20Diversified/idUSN1614796820090916

Can read into this that the Phase IIb did reach the desired results and Phase III will follow.

The part about "at least 2011" is really disappointing.  I wonder if it means Auxilium has gone as far as it's going to go without making some serious money off of Xiaflex.  They'll launch a major promotional campaign for Dupuytren's and set a very high initial price - probably just slightly under the cost of surgery - and after enough money rolls in, they'll get serious again about trials for Peyronie's.  

They may be in a bit of trouble. During the years they've spent grinding through the FDA approval process, a fairly simple, minimally invasive release technique for Dupuytren's called "needle aponeurotomy" has been steadily gaining acceptance and is now widely available.  This reduces the potential market for Xiaflex - maybe by a lot.  (I've already had this treatment myself).  If they can't make their earning projections for Dupuytren's treatment it may affect their ability to test and market Xiaflex for Peyronie's.

My interpretation of "at least 2011" is that there's no real committment.   As I understand it, Xiaflex could still be used off-label for Peyronie's - if any urologists are willing to try.

Hi, all.  Just FYI.  We were told several months ago by one of the uros involved in the intital and Phase 2 studies that it would take years - first visit 'years, last visit, till 2011 or 2012. I do not mean to be discouraging - only repeating what we were told.  Not the uro my gentleman friend is having to do the surgery, but he is also one involved in the studies.  Actually gentleman's doc is doing part of the phase 3 study.   We did ask about off-label after it comes out for Dupuytren's.  First expert stressed that if you could find a uro to use it off-label, be VERY careful about who you go to, and that my gentleman friend's doc most likely won't use it off label  (he also said because of lawyers - lol, I'm a lawyer!)  .. inference being the top docs may not do that.  The ones not familiar with this condition may just jump on the bandwagon, but do more harm than good.  Makes sense to me.  If you have an expert that may be willing, okay.  Some docs that we saw that supposedly deal with both D and P had never even heard of Xiaflex, period.  Just be careful.

Jazz

Seems like xiaflex for peyronies keeps getting pushed back, isn't the peyronies report due out in the fourth quarter of this year?  

Perhaps they are moving forward and getting the drug approved and to market for the problem that has the most patients(and can sell the most and make the most money) first.  So there are more sufferers of peyronies then frozen shoulder, hence the 2nd and 3rd order.  We could be reading into this to much....

How can a lawyer sue if it is FDA approved and or if the patient signs away any right to sue, can't this be done?

Personally at this point I'm still not convinced it works for peyronies and am waiting to see the report and hear from some people on here who say it does work.  Looks like I better refill my pentox prescription, i just got a 6 month refill prescription, however I"m now sick with the flu for the 3rd time this year, and this time its really bad, feel like i'm a in a death camp.  In my entire life I havent had the flu this often in such a short time period, I wonder how safe it is to stay on pentox for long periods of time if it does indeed weaken the immune system.  

Quote from: ComeBacKid on September 21, 2009, 10:34:43 PM

How can a lawyer sue if it is FDA approved and or if the patient signs away any right to sue, can't this be done?

"informed" consent is fertile legal grounds for a suit;

plus FDA approval notwithstanding, a physician could negligently or recklessly prescribe an FDA approved drug - (e.g., prosecutors are considering this theory for a charge of manslaughter/murder against one of Michael Jackson's physicians).

CF

Hmm,

Last time I checked "informed consent" was good enough to hold up in infant circumcision lawsuit cases where the infant didn't even have a say in what happened to him...  This kind of language sounds like its going down a path of lawyerism that will probably make my head spin and I won't understand.

 I suppose a urologist coulde use xiaflex recklessly if he injected it into someones heart, but if hes injecting it by the FDA protocol into someones penis and they signed away the right to sue i dont see why they are worried.  While I do study and follow case law in criminal and constitutional law, I don't know a thing about civil law procedure and lawsuits for money.  This sounds like it could get confusing and complex with different interpretations by different people...

I'm sure some urologist will offer the treatment, I'm more concerned about if insurance will cover xiaflex for peyronies off-label.

Quote from: ComeBacKid on September 22, 2009, 12:10:45 AM
Hmm,

This kind of language sounds like its going down a path of lawyerism that will probably make my head spin and I won't understand.

Of course, infants are legally incapable of consenting to just about anything.  And, informed consent requires the communication of all relevant information from the physician to the patient.  Xiaflex is so new, there may not be many doctors at this point even capable of providing informed consent for this drug.  

Keep in mind, most suits fall in the "grey" area of the law, not the "black and white" area.  Additionally, the law is constantly changing.  

Provided a suit is not frivolous (or, other similar characteristics), a civil complaint could be heard.  Whether it's a strong case or even a winner depends a lot on the respective counsel.  

Over 95% of ALL civil cases in this country are settled (never making it to trial).  So, it's hard to say if many or most of these cases would have "won" at trial.  

Settling a case brings certainty.

CF

You forgot to mention the one important fact regarding civil cases that I do know.

Unlike a criminal case where you need to prove guilt beyond a reasonable doubt, (reasonable varying from person to person).  In civil court one must only show a preponderance of the evidence.  This simply means that to prove that "something is more probable than not."   This standard of proof  is much easier, its no wonder many cases are settled then...

I think they need to come up with some kind of standard paperwork/form for those people who wish to waive rights to suit to try new and developmental drug.  I actually heard of someone who's kid had some diseases and they went to china for developmental stem cell treatment cause they couldn't try it in the united states.

comebackid

Comeback,

You say "If a physician injects the penis according to the FDA protocol"

That is the issue.  If it is used "Off Label" that means there is NO approved FDA protocol for penile injections.  That is why there are more clinical trials for Peyronies Disease yet scheduled, because it is still in the approval process.

I see trying to use a new drug such as Xiaflex that is somewhat invasive to boot in an off label application as a legal pandora's box.  No physician in their right mind is going to do it EXCEPT for PERHAPS Xiaflex experts participating directly or tangentially in the FDA approval process.  But just walking into a doctor's office and getting an off-label Xiaflex treatment is not going to happen here.  In Mexico perhaps, but not here.  And I would be the last one in the world recommending someone go to Mexico for treatment.  Look at it this way.  At least at this point you are probably still a potential candidate for surgery.  Things could be worse if you land in the hands of a nincompoop doctor with Xiaflex (or perhaps who knows what) in his syringe.  - George

Urologists are already prescribing an off-label drug treatment: transdermal verapamil. Unfortunately, it's worthless.   And it isn't necessarily harmless - it has systemic effects including alterations of blood pressure - so they're already taking some risk.  Quite a few people have now received Xiaflex injections over a number of years and no serious side effects have been noted.  If a high-profile urologist was willing to try Xiaflex, he might find a lot of guys running in the door with money in hand.  And with the knowledge he gained he might set himself up for nice consulting fees from Auxilium in the future.

I agree, I think a doctor such as Lue, or Levine (but not necessarily them) might well decide to proceed.  Is is unlikely to pose more risk that Verapamil.  I think they are innovative enough to be up for the challenge.

I would agree with that, guys.  When you talk about docs like Lue and Levine, they in my mind represent indirect involvement in Xiaflex research.  They live in a research environment and understand and respect the risks.  But I wouldn't go with any less than that.  Red flags are everywhere.  - George

It would be easy enough to just do a minimal injection, collect a few hundred bucks and remind the patient that he had nothing to lose.  Actually making this treatment work may require imaging, several carefully placed injections, and follow-up use of a traction device or a VED.    Fortunately, we have this forum, so we'll find out who's seriously trying to help their patients, and who simply sees this as the urological equivalent of the botox gold mine.

To J and Jazz. You should not be surprised about the 2011 or 2012 date.  If they go ahead, phase 3 will start next year and probably not finish until 2011.  This is always what they said and is their schedule.   

I guess I could interpret it that way, too. Hope you're right.

Does anyone know when Auxilliums quarterly report is due out in December?  They have announced that they will publish the results of the peyronies study with xiaflex in the last quarter of 2009.  I'm wonder what we can expect as far to the details of the study, and if they might delay publishing this.  We have tried to "guess" the results by the little feedback we got on this forum from participants, and as some have pointed out, we can't really form a conclusion until we get all the results.  This study in my mind will be a huge indicator if the drug will ever make it to market for peyronies.  If we see vague language with no details, I would suspect a cover up of a failed study.  On the other hand, lots of details and good results will almost assure us that they will move forward with the drug.  This is a huge "fork in the road," moment for this drug and the future treamtn of peyronies.  Since no other major drug is in the pipeline, a lot of people's hope rides on the success of xiaflex.  I sure hope we hear positive news...

I think the last of the guys complete the phase IIb study the end of this month, Oct. 09. I am sure that it will take some time to crunch the numbers. It is my understanding that phase III is to start mid 2010. I do wonder how things are going with approval of Xiaflex for Dupuytren's contracture by the FDA.

For everybodys sake,  I sincerely hope there is great news for all!

Auxilium presented at a healthcare conference a few days ago. Apparently the "top line results of peyronie's phase IIb study are due Dec 09" and initiation of peyronie's phase III studies starts in 2010.

and had the pericardial patch this past week...
no change in my 70 degree bend...
i believe in my study group there was 1 person that improved from 60 to 30 and that was THE highlight of the 10 man group..

no miracles in chicago.

Quote from: bones54 on November 11, 2009, 04:54:17 PM
and had the pericardial patch this past week...

Whats the pericardial patch?

So you saw no change in your bend? Still though, only 10 people we can't draw results from this.

Comebackid

Yesterday, on a Dupuytren's forum which I follow, someone who had been a patient in the Phase III Xiaflex study (for Dupuytren's) posted some very positive comments. One thing he/she said was: "Treatment with xiaflex is no different than surgery or NA. The success rate is dependent on the skill of your doctor. Get a bad one, and you should expect a bad result. Luckily, my doctor was excellent and had excellent results." 

J,

Thanks for your post, its great to hear this positive news! I' d imagine the injection skill does matter.  Which brings me to my question for anyone who has gotten the xiaflex injections.  Is it a light "dab" shot like a tetnus , or do they inject the needle way into your penis?  Seems like you'd need lots of "light dabs" all around the penis in my case, since it is like a cast of scar tissue.

Comebackid

Quote from: j on November 14, 2009, 11:31:34 PM
Yesterday, on a Dupuytren's forum which I follow, someone who had been a patient in the Phase III Xiaflex study (for Dupuytren's) posted some very positive comments. One thing he/she said was: "Treatment with xiaflex is no different than surgery or NA. The success rate is dependent on the skill of your doctor. Get a bad one, and you should expect a bad result. Luckily, my doctor was excellent and had excellent results." 

Due to differences in dupuytrens and peyronie's it seems to me that there's more scope for very dramatic success through xiaflex use in dupuytrens. That's not to say that it doesn't hold any use for peyronie's, and what you say about getting a good doctor is a very relevant point.

I see Xiaflex for peyronie's as another potential tool that will improve our situation in addition to the mechanical (ved, traction) and oral supplement (pentox etc) route. Of course this is just my take. I'm looking forward to seeing more Xiaflex results published :).

Quote from: newguy on November 15, 2009, 02:09:28 PM
Due to differences in dupuytrens and peyronie's it seems to me that there's more scope for very dramatic success through xiaflex use in dupuytrens.

I think that's true, but success in either case depends on the doctor understanding exactly where the bad tissue is, and how and where it's hanging you up.  Xiaflex will be used by hand surgeons who have detailed knowledge of the hand's inner workings.  The good ones will figure out where they can best release a contracture with minimal collateral damage. If a urologists just walks into the room, shakes your hand and injects some Xiaflex, I wouldn't expect much.  But if a surgeon, guided by imaging, figures out where you're 'bound' and injects in the right spot - and follows up with stretching - the results could be good.  If your problematic area is large and diffuse, a different technique would be needed.

Basically Xiaflex 'eats' the fibrotic tissue.  It's a new tool, and now people have to figure out how to use it.

J,

You say xiaflex "eats" the fibrotic tissue, it must do this while leaving good healthy tissue alone.  My question is once the bad tissue is "eaten," is it gone forever, ist it replaced?

Comebackid

Not sure if this has been posted before but it gives good info on the working of Collagenese (Xiaflex)

http://www.springerlink.com/content/w186814545008546/fulltext.pdf

my basic interpretation is good tissue is left alone. As for disolving tissue I don't know, I think it rearranges the collagen fibres by breaking their structure, I'd hope restoring some of the original elasticity.

4-5 weeks and results of Phase IIb trial should be announced.

Here's what I think I know:  Xiaflex is a form of collagenase,  an enzyme that breaks up (metabolizes, dissolves, "eats") collagen. There are several types of collagen, and the action of Xiaflex is at least somewhate specific to the type of collagen found in Dupuytren's/Peyronie's tissue.  It doesn't distinguish "good" from "bad" per se, and the unwanted collagen is of a type also found elsewhere in your body in normal tissues, possibly even close to the "bad" tissue.  So, it has to be used with care. The idea is to inject just enough to do the job and not escape into surrounding tissue.

At this point, it would be great if someone with real knowledge (say, someone from Auxilium) would jump in and correct any errors or misinformation I'm spreading.  However that isn't likely to happen, so we're left to speculate based on whatever information we can obtain.

I think that if collagenase/Xiaflex does not harm non-peyronie's tissue that a transdermal approach miight be an effective conservative approach. I understand that it has a low enough mollecular weightto pass through the skin. What do you guys think?

Rockwall

My understanding is that it can in fact harm "good" tissue and needs to be carefully targeted.  Auxilium already has a topical collagenase product called Santyl that is used to reduce scarring in wound healing. They've just spent millions developing Xiaflex which is  basically an injectable form of collagenase.  If Santyl had any usefullness against Peyronie's, they'd already be marketing it.

Well J I have already tried it with Santyl some time back. I would apply the ointment over the plaque, rub it in, then cover the area with a cotton patch soaked in DMSO and soak with a plastic wrap over the top for about an hour. I can't say that it helped but also can't say that it hurt. It did change the underlying structure temporarily to a sort of ropey look. It did not appear to harm the skin. It believe that this product is mixed with petroleum jelly and I thought that not enough of the enzyme might be in a free enough form to penetrate effectively. I did this for at least a month on two separate occasions. I stopped both times due to scheduling problems and not application problems. I do not want to encourage others if damage is possible but, this was my experience. I have wondered why Auxilium have marketed through Uros with injectables and not for topical home treatment.

Rockwall

I think some people have tried Santyl for Dupuytren's too and found it did nothing.  

J,

Getting correct information would be a good idea, or better yet to give Auxilium the chance to correct information or some kind of an exchange.

A few years back Larry H wrote Auxilium with no reply.

Currently in the advocacy,awareness, activism section we are working on a mass mailing project to recruit new members to grow our membership.  Towards the spring we may write Auxilium and reach out to them, we will have to decide if this is something we want to do, I've been thinking about it for awhile. As for now we will continue to work on our project and do that thoroughly and completely.  There is not point to reach out to Auxilium right now as we are still awaiting their study results due out in December.  It would be good to get some kind of an information exchange with them, maybe even specific questions we could submit to them to answer, or just to open up a line of communication with them, since we need them, and they in theory need us to sell their product to.  It could benefit us and them, and would certainly be good PR on their part.  Whether we do reach out to them, what we approach them with,a nd if they respond remains to be seen. For now I think we should take everything we've seen to date with cautious optimism and look for a detailed and specific report hopefully in December.

Comebackid

I was in the Xiaflex study and have inquired about the test results. According to the study coordinator in my urologist's office, they were told that results would be made available sometime after the new year. Nothing more specific. Unless the schedule changes, we will not know anything in December.

Thats disappointing they have pushed back the results they originally said they would release in the 4th quarter of 2009. I don't know if this is common practice or not, of if these means anything.  Someone with shareholder reports and more corporate experience might weigh in here...

Comebackid

Can anyone bring some light on the reason Auxilium has not received the FDA approval for Xiaflex in the treatment of Dupuytrens Contracture? Phase III was completed and a committee related to the FDA all felt it was a go.

http://seekingalpha.com/article/166413-auxilium-inches-toward-fda-approval-for-xiaflex

Following a very positive FDA review, consensus is that Xiaflex will receive formal approval from the FDA in about two months and Xiaflex will be on the market two months later in January 2010.

When will the FDA announce approval decision?  Can they reverse a decision at a later date if the drug is found dangerous?  I guess if it is approved for safety, doctors could then use it off label for peyronies, I wonder if any major urologists will try it?  We still await the report that was supposed to be published in Dec. but won't come out until the new year. 

Comebackid

Overall results:


--  In patients who received XIAFLEX, a mean improvement of 29.7% in
    penile curvature from baseline to 36 weeks was seen (54.4° to 38.2°) vs. an
    11.0% mean improvement in curvature seen in placebo patients (50.6° to
    45.1°); (p=0.001).
--  In patients who received XIAFLEX, 60.5% of patients achieved the
    endpoint of at least a 25% reduction in angle of curvature vs. 25.0% of
    placebo patients achieving at least a 25% reduction in angle of curvature.
--  In the PRO Peyronie's disease bother domain, the overall XIAFLEX
    treatment arm experienced a benefit in mean change in score from baseline
    to 36 weeks that was significantly better than the overall placebo arm
    benefit (p=0.046).
--  There was not a statistically significant change in mean scores
    between XIAFLEX and placebo in the PRO penile pain, intercourse discomfort
    or intercourse constraint domains.
   

Results with modeling:


--  XIAFLEX treated patients who received modeling experienced a 32.4%
    mean improvement in penile curvature from baseline to 36 weeks (54.7° to
    37.2°)  vs. a 2.5% mean worsening in curvature for the placebo patients who
    received modeling (51.9° to 52.5°); (p < 0.001).
--  In patients who received XIAFLEX, 64.8% of patients achieved the
    endpoint of at least a 25% reduction in angle of curvature vs. 10.0% of
    placebo patients achieving at least a 25% reduction in angle of curvature.
--  In the PRO Peyronie's disease bother domain, the XIAFLEX with modeling
    treatment arm experienced a benefit in mean change in score from baseline
    to 36 weeks that was significantly better than the placebo with modeling
    arm benefit (p=0.004).
   

Results with no modeling:


--  XIAFLEX treated patients who received no modeling experienced a 27.1%
    mean improvement in penile curvature from baseline to 36 weeks (54.1° to
    39.1°), which was not statistically different from the 27.9% mean
    improvement for the placebo patients who received no modeling (48.9° to
    35.9°); (p=0.91).
--  In patients who received XIAFLEX, 56.4% of patients achieved the
    endpoint of at least a 25% reduction in angle of curvature vs. 43.8% of
    placebo patients achieving at least a 25% reduction in angle of curvature.
--  The mean change in score from baseline to 36 weeks did not achieve
    statistical significance in any of the four domains measured by the PRO for
    the XIAFLEX treatment arm with no modeling vs. the placebo arm with no
    modeling.
--  Based on a post-hoc sub-group analysis, the Company believes that the
    results from the non-modeling placebo group may have been biased by a
    higher relative percentage of patients with a shorter duration of disease
    (i.e. less than or equal to 18 months) and that the non-modeling placebo
    group may have had more spontaneous resolutions of disease.   We believe
    that this imbalance may help to explain the higher than expected placebo
    response in the no modeling arm.
   

Validation of Peyronie's Disease PRO


--  The Company believes that the Peyronie's Disease PRO will be validated
    by data from 134 patients (100 XIAFLEX; 34 placebo) during this phase IIb
    trial; however, final determination will require further discussion with
    the U.S. Food and Drug Administration (FDA), which is expected to take
    place at the end of phase II meeting in the second quarter of 2010.
   

Ok now in english, maybe tim could give his opinion on this study.  Uk, was this the official results from the study we've been waiting for?  I thought this wasn't coming out until Jan. since it got pushed back? ???

Comeback

CBK,

Assuming these are legitimate results, it looks like the phase's treatment yielded about a 30% reduction of curvature which is probably pretty significant; not 100%, but could make a great deal of difference to the individual.

I'm have no idea what kind of "modeling" was used, but maybe the drug in combination with the VED could produce great results. 

CF

I know when I was taking the Verapamil Injections they were doing modeling too to some patients. They were modeling the plaque by hand. If I understood correctly they were kind of manipulating the plaque by hand manually bending the plaque in the opposite direction of the curvature. I opt not to do it because the VI injections were invasive enough and it just seemed to me it mite do more harm then good in my case. I didnt want to cause any more damage and when I asked the PA how long they have been doing it to the VI patients he said they just started and really didnt know what the results were at that point.

the results are available on Auxilium website

http://ir.auxilium.com/phoenix.zhtml?c=142125&p=irol-newsArticle&ID=1366444&highlight=

They read disappointing to me in a lot of areas. Placebo even showed considerable improvement which I personally don't put down to spotaneous resolution as Auxilium say but the tearing of scar with the needle (Lariche effect?).
13 odd injections for a 60% chance of a 25% improvement in curvature - no thanks not for me and I am desperate for some treatment as is the next man.
2012 is the earliest date , that's if it ever makes it to Phase III with these mixed results.

UK,

2012 until it is approved for peyronies, I assume you mean, but remember it could be used off label before then!  Yeah these results aren't to impressive, although remember in the initial trials like phase II a company is using more conservative injections, just trying to prove safety to the FDA.  Maybe more collaganese is needed in the injection.  Thanks for the link on this UK!

Seeing as I've used modeling such as the VED which helped me somewhat, I question when people say they are getting verapamil injections and modeling whether its just the modeling helping them.  I still have yet to hear from people who say verapamil injections cured them, I"ve heard several say it made them worse.

Comebackid

Quote from: ComeBacKid on December 17, 2009, 09:20:50 AM
Seeing as I've used modeling such as the VED which helped me somewhat, I question when people say they are getting Verapamil injections and modeling whether its just the modeling helping them.  I still have yet to hear from people who say Verapamil injections cured them, I've heard several say it made them worse.

I don't have any names..... but I do have a data point from Dr. Levine that I have previously shared. I know Levine does a lot of Verapamil injections. He told me that 60% of his patients "respond favorably" to them. He does not do the modeling, simply does the injections.

I believe you, but frankly I don't believe that statement from Dr. Levine.  Just looking at our unscientific, yet pretty darn accurate poll, virtually no one responded well to verapamil injections.   Verapamil has never been proven to break down collagen.   I think some doctors will just defend what they promote and do, others can step up and admit what they were doing was wrong/doesn't work.  Where are all the studies showing the effectiveness of verapamil injections? I don't believe verapamil works at all, and some have argued its the needle injections helping, kind of like the lariche technique.

Comebackid

I have to agree with comeback kid. One of the urologists I saw (who is an expert and has done many verapamil injections) knew of Levine's 60% rate and said that his own rate was more like 25-30% success. He thought the swisscheesing effect or just the introduction of fluid into the plaque was responsible for success and NOT the verapamil. 

Hey guys,

I let my personal doctor/therapist read the results of the xiaflex study.  He to has come down with peyronies after getting his bladder removed from bladder cancer.  We must be misguided in our opinions.  He said he has read hundreds of these clinical trials and the results from xiaflex are GOOD!

Comebackid

Hey guys,

Not sure if you guys have seen Dr. Levine's webcast describing Peyronies Disease and treatment but here is the link:

http://webcasts.prous.com/AUA2007/pop_up_bio.asp?sid=163&id=277&q=auto&v=auto&webcast=course01&CID=&CLID=2#

On slide 8 out of 25 (~8 min and 27 s into the video) he talks about verapamil injections. Slide 9 gives a video of him actually demonstrating how he does the injections into a penis, which somewhat shows the he doesn't do much physical damage with the needle itself besides depositing the therapeutic. Finally, on slide 10 he talks about various studies which you can likely pubmed if you would like of results using these injections and a couple of the studies (Some of his) suggest this 60% success rate he has been claiming. I think it would be agreed that Dr. Levine is one of the more active researchers in the field and is the primary factor in promoting the PAV cocktail that so many people on this forum praise, so I do not think Dr. Levine would be fudging any sort of results with these injections. Moreover, these are peer-reviewed published studies so he would have encountered resistance from reviewers/editors of journals had his results been abnormally off from others in the literature but the results are there so they speak for themselves. In this webcast you see Dr. Levine (Who I have not met) be very critical of the literature and he attempts to dispell any sort of internet vodoo surrounding Peyronies Disease and it's treatment options quite extensively. Thus, I would think he would be very critical of his own work, especially if it would involve invasive procedures such as intralesional injections.

On the other hand, Dr. Levine has commented on these Xiaflex results on that Auxilium website right below the results of the trial. He stated: "XIAFLEX has shown a sustained benefit at 36 weeks versus placebo for patients suffering from Peyronie's disease...The drug had a statistically significant reduction in penile curvature and demonstrated statistically significant improved quality of life for patients as measured by the PRO domain for Peyronie's disease bother. Getting these efficacy results without the risks of surgical intervention would be an enormous advantage for patients suffering from Peyronie's disease."

So it's interesting that what seems to be not the greatest results (Average curvature improvement of 30% in the Xiaflex group vs. what I would think to be an abnormally high improvement in the saline group), Dr. Levine nevertheless seems optimistic. Thus, I think his statements only echo his genuine attempt to help Peyronies Disease sufferers and in essence support his use of verapamil injections. Whether I, or my uro (A friend of Larry as he calls Dr. Levine) have attempted the verapamil injections in another study  :D

Quote from: ComeBacKid on January 12, 2010, 01:17:18 AM
Hey guys,

I let my personal doctor/therapist read the results of the xiaflex study.  He to has come down with peyronies after getting his bladder removed from bladder cancer.  We must be misguided in our opinions.  He said he has read hundreds of these clinical trials and the results from xiaflex are GOOD!

Comebackid

Well that sounds promising!  Please keep us posted.

bart15,
Thanks for posting the Levine webcast. I had not seen it before. The whole thing is about 20 mintues and everyone who suffers from Peyronies Disease would be wise to watch it. In 20 minutes Dr. Levine gives a very good overview of various Peyronies Disease treatment methods and why he prefers the approach he takes. I would encourage everyone to set aside 20 minutes and watch this.

The thing to keep in mind with Xiaflex is that this is the initial testing phase.  If the results are significantly promising as they seem to be, they are going to be tweaking their procedures and things are only going to get better as they go along.  As they work with this drug, things could get pretty amazing.  We can all hope for the best as the pros (like Levine) are giving Xiaflex a thumbs up as a Peyronie's treatment.  I suspect the best Xiaflex results will be seen in concert with something like Pentox in order to throttle the underlying process while blowing away the physical plaques.  This is all really good news.  I am impressed at this point.  - George

Besides Peyronie's I have (steadily progressing) Dupuytren's, and with luck I expect to live a few more decades, and I can't keep on having my hands hacked up with conventional surgeries - they do way too much collateral damage, and surgical techniques can't get access to some of the most problematic areas.  So I'm counting on Xiaflex as an alternative.

I think it's all about imaging, and finding ways to get just enough injected into just the right places.  Remember that the potential market for Dupuytren's treatment is huge compared to Peyronie's, and hand surgeons can be a lot more agressive than urologists, because it's easy to see what's going wrong, and safe to get a bit rough with the bad tissue.  They'll find ways, and the urologists should eventually pick up on these techniques.  I'm convinced this is going to work, it's just a matter of time.

Goodmorning all, I have been one of the participants in the Xiaflex study and have gone through all treatments, tests and measurement studies throughout the process.I have flown from Pittsburgh Pa.to New Haven, Connecticut for every single treatment,bloodtests,consultations and what not.My doctor had a meeting with the Xiaflex people last week about all his patients in the study.Unfortunately I found out that I was one of the ones in the placebo group.(of which I suspected anyway)The good news is that I will be included in the next phase trial in the Summer of 2010.I will be one of the ones that will get the real drug.Believe me,It is a relief to know that I was in the placebo group because if not I was sure that the drug was not working for me.The doctor also told me that he had very positive results with his patients that got the drug.I have been reading this website daily for about 2 years.I have gained so much knowedge about this problem that is scary! I just would like to thank everyone that posts info on this site.Thank you.Ticker

Xiaflex is a version of santyl an oinment that is used for debriding necrotic tissue in patients that have ulcers. Just wondering why not use santyl as an oinment on the affected area instead of a vesion that is injected?

janvera - where can you buy this and how do we apply it??

This has come up many times before.  Forget about Santyl, it doesn't penetrate, it's only for topical use in wound healing. It would have no effect on Peyronies or Dupuytren's - otherwise it would have been marketed for those conditions long ago.  The reason Biospecifics and Auxilium spent millions developing Xiaflex was to get an injectable form of collagenase, which can attack bad tissue below the skin.  They already had Santyl.

j - heres a thought what about using this with DHSMO solution - sought of Thackers type of theory???

Again, if it were that simple, BSTC and Auxilum wouldn't have spent all this time and money on Xiaflex.  I don't think DMSO has any place in serious medical treatment today. It's a solvent that can easily penetrate your body tissues and - maybe - carry things with it - possibly including contaminants and toxins.  Even if it did move collagenase through the skin - which I doubt, because the molecules are too large and complex - there's no way to control where it would end up. It might go straight into your blood stream and be carried anywhere.    Collagenase dissolves certain kinds of tissue and it doesn't necessarily know 'good' from 'bad', so it's not something you want loose inside your body.

To have any serious, significant effect on Peyronie's tissue - without doing collateral damage - collagenase has to be very accurately delivered, in sufficient strength.

Approved by FDA and available from March 2010, however if anyone was hoping for off-label that is unlikely as only doctors that have undergone specific training for Dupuytrens will have access to the drug

http://www.prnewswire.com/news-releases/biospecifics-technologies-corp-announces-fda-approval-of-xiaflextm-for-treatment-of-dupuytrens-contracture-83410887.html

this is excellent new, i thought it was going to take much, much time to actually be on the market. its not so hard to have a off label use. A lot of medications have off labels uses and they work well. Thanks for posting this wonderful information.

Does xiaflex now need to be approved for peyronies to right?  That should come within two years , shouldnt it?  This is also important cause now they can try more aggressive treatments with the xiaflex, they were probably conservative to begin with to prove safety to the FDA.

As I understand it the Clinical Trial Phase III for Xiaflex in the treatment for Peyronies will start mid 2010. After the complement  of the trial and review of data it will be submitted to the FDA for approval. Time line approx. a year and a half to two years.

The approval for Dupeytren's is important since it means that now there is a money flow on this product which will help to fund further Peyronie's testing.  Thus, things should move faster now than before when there was no income on this drug yet.  - George

http://www.kernsuslow.com/research/auxl_oct1508.pdf

This investment analysis answers many questions about Xiaflex, and is generally negative on its prospects for both Peyronie's and Dupuytren's. It's written by an MD who seems - to me - fairly knowledgable about these conditions; whether he has an axe to grind, I don't know.  I'm not taking all of his conclusions at face value. I agree with most of what he says about Dupuytren's, but I think the situation with Peyronie's is different in some important respects which are not acknowledged in this report.

By now, the company has to know if this drug is for real or not, either it helped a significant amount of people with peyronies or not.  The only option to try, is a more aggressive injection method.

Comebackid

is this bad news????

I don't know, it sounds like this doctor doesn't believe in the hope of Xiaflex!  My doctor who has peyronies claims this is a good study, and that in the early stages, they don't use aggressive treatment injections, as they are just trying to prove safety to the FDA.  

Comebackid

so when will we use it

Quote from: ComeBacKid on February 17, 2010, 01:13:49 AM
I don't know, it sounds like this doctor doesn't believe in the hope of Xiaflex!

I didn't get that impression.  His commentary analyzed the business model of Xiaflex and he raised some questions as to whether the drug would be profitable.  Some of his opinion is based on the research results which show that although the drug achieved "success" in a significant number of patients, the same "success" has been achieved by VED use (anecdotal results) and Traction (Dr. Levine); and he therefore questions whether a sufficient number of effected men would choose to go with the drug either in addition to or instead of the VED and Traction since Xiaflex would be considerably more expense than the VED or Traction.  He also questioned whether insurance companies would reimburse patient's Xiaflex costs.

IMO, he didn't question whether some patient's achieved "success" with Xiaflex.

So, it's just a analysis made available to current and potential company investors.

CF

Like cowboyfood says, this article - while it contains a lot of good medical information - is basically a market analysis by someone who thinks Auxilium won't make big money on Xiaflex.  It's only bad news if he's right, and Auxilium folds, or stops selling Xiaflex.  I doubt that will happen. They won't make the huge profits they've been dangling in front of their investors, but hardly any companies ever do.   

Most of the autho'rs medical analysis focuses on Dupuytren's, where there are other, competing treatments that may still be preferrable.  When he talks about Peyronie's he gets pretty vague, even saying it's often a 'cosmetic' problem, and alluding to other treatments without naming them.

J,

Wouldn't it also be bad news if the health insurance companies don't cover xiaflex as a treatment for peyronies?  Isn't this what hes arguing as well as the point you make?  If they say we won't cover this, cause you can use VED or something else, and we know whats best for you and your peyronies disease! >:(

Therefore not enough people will elect to pay for xiaflex on their own, and the drug won't be profitable, and Auxilium will scrap it, I hope this is not the case!

Comebackid

Yes that would be bad, although if it actually worked for Peyronie's, guys would be selling their cars to pay for it. 

I think what will really happen is that the price will come down.  For Dupuytren's they're trying to get the insurers to pay as much or more for Xiaflex as they would for surgery.  I don't think that will fly.   

Remember, the retail price for a drug or therapy is not the price that the insurers pay.  The large insurers all negotiate a contract price with the vendor for a specific product or service which is usually less than half the retail "list" price.  - George

That's right, George, and that's the part that companies like Auxilium don't tell their investors. They're still talking about a "premium price" (their words) for Xiaflex and floating numbers in the thousands for a typical individual treatment - and that's just the Xiaflex, not including the doctor's fees and all the rest.   It's hype.  We'll see what the future brings.

The bottom line is - this stuff breaks up Peyronie's Dupuytren's tissue. It's all a matter of how it's used.  In the trials it was just "bang" - one big injection, and hope for a very small improvement.  This minimized Auxilium's costs - including payments to the MDs - and was enough for the FDA.    And big injections move a lot of expensive product.  But that isn't necessarily the way to really make this work.  Maybe what's required is a lot of very small injections throughout the problematic tissue over a period of time.  

Was in the Xiaflex study and no change in my condition. Just got the news today that I received the placebo and will not hear anything further about the next step until the fall of 2010.

Does anyone know if when there is a small phase II study such as the Xiaflex study, the drug company selects participants at random to receive either the Xiaflex or placebo OR would they select some participating physicians at random to receive all placebos for their patients and other physicians would have all their participating patients receive the actual drug.

The reason I ask is that my urologist told me that none of his patients improved and he thought that they all must have received the placebo.

 

George,

I realized that medical facilities negotiate separate rates, when I went into a routine clinic for a routine cold to see a doctor.  I wanted to know what it would cost me in cash if i had no insurance.  So if you pay cash it might be $100 for the doctor visit.  My insurance company had a negotiated rate of $65, meaning the medical facility and the doc bill them a lesser amount, of which i only pay 10% of (this is the insurance part, the whole point of having it).  Seems to me like if your paying in cash your getting ripped off.

Now for something like xiaflex how will it work, say I went to a doctor to have injections who negotiates with my insurance company for a rate, the doctor, or auxilium? Some insurance comapnies might only cover a certain amount for the drug?  So a doctor who charges more, might mean i pay more for the amount my insurance company doesnt cover?! ??? How do you know if the injections are covered by your insurance at all?  Do you have to call the insurance company or if the doctor accepts your plan, does that mean the insurance company will pay for anything your doctor does?

And for J's comment, my doctor said he has read hundreds of clinical trials and the xiaflex results were good, he said in this FDA phase they just prove safety and arent going for spectacular results, so they could improve with a different treatment protocol I suppose.

It can work both ways.  I just paid in full out of pocket for a medical test.  It cost me about $250 up front.  I didn't think it would be covered by my insurance.  I was wrong.  The lab turned around and billed my insurance company $1,000 for the same test.  The insurance company paid them their contracted rate of around $500.  So now the lab is ahead by double and I will get most of my $250 back, except for the copay, deductible and such.   The whole system is so arcane that no one can figure it out.  - George

It's like airline tickets.  Next time you're on a flight, start asking other passengers what they paid.  Sometimes you get prices all over the map.

I found this forum from a google search and checked it out. It looks pretty cool here.


This member banned for creating a spam account.

On February 17, 2010, Auxilium announced the list price to distributors of XIAFLEX as $3,250 per vial and stated that it anticipates that Dupuytren's contracture patients treated with XIAFLEX will have 1.5 cords treated, on average, and that each cord will be treated with an average of 1.1 vials of XIAFLEX.

http://www.prnewswire.com/news-releases/biospecifics-technologies-corp-reports-fourth-quarter-and-full-year-2009-financial-results-87265677.html

the question is how many vial(s) are needed per sq cm/inch of peyronie's plaque?

I don't think anyone has, at this point, a clear idea of how much Xiaflex might be used to treat Peyronie's.  I think all they did in the trials to date was inject "some" and hope for a small improvement.


For Dupuytren's the situation is a little clearer because surgery is common and "success" is fairly well-defined.  It looks like Auxilium is trying to price Xiaflex about 10 cents lower than a typical surgery and is hoping the insurers will pay.  They've apparently sized a "vial" as roughly what would be needed for release of a typical Dupuytren's cord. 

After consulting my friend/doctor/peyronies sufferer, he told me the point of FDA trials is only to show safety, more aggressive approaches can be adopted at a later date.  This was like a trial run and they just wanted to clear a few hurdles, they won't go all out until the final race.  

That price doesnt look that bad or steep. The big thing will be is the insurance company going to cover it? And if they do will they deny coverage by asking about a pre-existing condition, which just happened to me the other day over a mix up on another treatment regarding headaches which were sinus related but on paper looked like a brain tumor to my insurance company.

I don't know how an insurance company desides to cover the drug, but just cause its FDA approved doesnt mean it will be covered, sometimes the doctor can write and or call to get the insurance company to pay for a treatment.  

You'd have to think this drug should be covered, I mean its the only main drug for peyroneis other than pentox that has shown to be successful at all outside of surgery.  Surgery can be pricey as well.  

Another point is how many vials will be used in treatment?  Some people have lots of plaque and or calcification, will more or less be needed for some people?  Doppler ultrasounds may be used to indentify location and or thickness/amount of vial needed for treatment.  This could make everyones treatment course different.  There will probably be a base treatment protocol, with a more aggressive approach or less aggressive approach for different people allowed by the doctors.

Comebackid

Quote from: ComeBacKid on March 12, 2010, 09:11:05 PM
After consulting my friend/doctor/peyronies sufferer, he told me the point of FDA trials is only to show safety, more aggressive approaches can be adopted at a later date.  This was like a trial run and they just wanted to clear a few hurdles, they won't go all out until the final race.  

That price doesnt look that bad or steep. The big thing will be is the insurance company going to cover it? And if they do will they deny coverage by asking about a pre-existing condition, which just happened to me the other day over a mix up on another treatment regarding headaches which were sinus related but on paper looked like a brain tumor to my insurance company.

I don't know how an insurance company desides to cover the drug, but just cause its FDA approved doesnt mean it will be covered, sometimes the doctor can write and or call to get the insurance company to pay for a treatment.  

You'd have to think this drug should be covered, I mean its the only main drug for peyroneis other than pentox that has shown to be successful at all outside of surgery.  Surgery can be pricey as well.  

Another point is how many vials will be used in treatment?  Some people have lots of plaque and or calcification, will more or less be needed for some people?  Doppler ultrasounds may be used to indentify location and or thickness/amount of vial needed for treatment.  This could make everyones treatment course different.  There will probably be a base treatment protocol, with a more aggressive approach or less aggressive approach for different people allowed by the doctors.

Comebackid

If this drug is proven effective I certainly hope insurance companies decide to cover it.  However, remember that insurance companies make their money by denying coverage.  I know this is not the place for political discussions, but I reaslly wish that congress and the Obama administration could get their act together and do what is right for the American taxpayers, not what is politically expedient.

Fred                                                           

Here's an article in today's NYT:

http://www.nytimes.com/2010/03/16/business/16hand.html?pagewanted=1&hp

Update:

There will be a presentation at the American Urological Association (AUA) 2010 Annual Meeting on June 1, 2010 on the Phase 2b results entitled: Improvement in Penile Curvature and a Patient Reported Outcome Endpoint in Patients with Peyronie's Disease: Results from a Phase II Study of Collagenase Clostridium Histolyticum.

Hopefully there will be good news.

Xiaflex- Collagenase Clostridium Histolyticum

Dosing for Dupuytren's contracture is as follows-(Via Epocrate's Drug Dictionary for PDA's,-Oxford Formulary guide)
[0.58mg intralesionally x1]
Max: 3 doses/cord; Info: may repeat q4wk x2 doses

Renal and Hepatic doses are not defined.

Contraindications/Cautions:
Hypersensitive to drug/class/compon. caution if coagulation disorder

Caution Advised:
Antiplatelets
Aspirin
Aspirin/Caffeine/CNS depressant combos
Aspirin/Muscle Relaxant combos
Aspirin/Opiate combos
Bivalirudin
Diclofenac topical
Drotrcogin alfa
Fondaparinux
Heparins
Hydrocodone/Ibuprofen
Ibuprofen/Oxycodone
Lansoprazole/naproxen
NSAID's
Omega-3-Acid
Platelet GP IIb/IIIa inhibitors
Sumatriptran/naproxen sodium(Alleve)
Thrombin Inhibitors
Thrombolytics
Warafarin


Adverse Reactions:
Tendon Rupture
Ligament Damage
Complex regional pain syndrome
Sensory abnormality
Allergic rxn


Common Rxn's:
Peripheral edema
Contusion
Inj site hemorrhage
Injection site rxn
Extremity pain
Tenderness
Injection Site Adema
Pruritus
Lymphadenopathy
Skin Laceration
Lymph Node Pain
Erythema
Axillary Pain

Pharmacology:
Metabolism- Unknown; CYP450: Unknown, Info; Minimal/No systemic absorption

Excretion: Unknown; Half-life:unknown..

Mechanism of Action: Hydrolyzes collagen, resulting in lysis of collagen deposit and enzymatic disruption of cord(collagenase).

Today is the day that the results of the Xiaflex trials are presented at the AUA conference.  Anybody heard any news yet?  (Also my birthday, so maybe a really great present).

Fred

I have been looking, but have seen nothing yet...

Quote from: SSmithe on June 01, 2010, 04:53:02 PM
I have been looking, but have seen nothing yet...

Still doesn't seem to be anything on the internet.  I wonder if they even reported the results?  I would have thought there would be more interest here.

Fred

Lots of Xiaflex news today.  This link below is a video with the Auxilium CEO discussing the companies future, Dupuytrens, and Peyronies.  He says Phase III trials for Peyronie's may start later this year... My fingers are crossed.  www.washingtonpost.com/wp-dyn/content/video/2010/06/08/VI2010060803088.html
SSmithe

ok great video - the CEO sees like a nice guy BUT where are all the people wjo were in the trials - why dont we hear anything from them - where have they all gone - why arnt there any results  - are there any positive results out there  - seems like people have just disappeared - no one seems to say anything - we are left in the dark here!!!!!
There might have been 1 or 2 posts on this forum but where are all the other people who took xiaflex??

Quote from: Iceman on June 09, 2010, 06:32:00 AM
ok great video - the CEO sees like a nice guy BUT where are all the people wjo were in the trials - why dont we hear anything from them...

I think the bottom line is that very few people having a particular medical problem will actually ever find a web forum (like this one) and of those that do, only a very few will actually post.  And the ones that post may not be a representative sample.

Most people make only rudimentary use of the web, and are very timid about using a search engine like Google.  There seems to be a huge fear of being 'found out' or spied on, especially when a sensitive problem like Peyronie's is involved.

Where there any results published?  I watched the clip, seems like they are moving along as scheduled and could see the product on the market in 2011?  But they have est sales for 2011 400 million, is that their estimated sales?  How much have they made on this product to date, does anyone know from their stock profile?  Eventually I'd think you'd have to produce and product that works and sell it, or the share prices will tank, looks like their share prices keep going up, and they havent actually commercialized the product yet?  I'm still slightly skeptical, but the fact that they are moving the product on schedule is a good sign.  The regulatory process will slow down the product somewhat to ensure safety. 

I noticed he didnt mention frozen shoulder, did they give up on that as well? 

Could be the time to reach out to Auxilium with a letter right around the new year, what do you guys think?

Comebackid

Quote from: Iceman on June 09, 2010, 06:32:00 AM
ok great video - the CEO sees like a nice guy BUT where are all the people wjo were in the trials - why dont we hear anything from them - where have they all gone - why arnt there any results  - are there any positive results out there  - seems like people have just disappeared - no one seems to say anything - we are left in the dark here!!!!!
There might have been 1 or 2 posts on this forum but where are all the other people who took xiaflex??

I was in the Xiaflex trial, but I saw no improvement...   I believe I must have received the placebo.   :'(  I am now on Pentox which is helping a lot and have just started with the VED.

-Joe

Joe, is there anyway to find out whether you got the placebo or not? Won't they tell you? How many injections did you get and over what period? Do you think the injections didn't help (or hurt)? The reason I ask is because Dr. Mulhall told me that it may be the swisscheesing effect that helps with verapamil injections. At the same time it seems that many people are effected negatively from verapamil injections. Anyway, I'm glad you're on pentox and it appears to be working. I would recommend you look into traction and hyperthermia. Thanks and good luck.

I talked (by e-mail) with the assistant of a very well known male sexual function specialist who attended the conference and said he heard nothing regarding the reporting of the Xiaflex trial results.  He was also rather negative regarding Xiaflex as an effective treatment.  But who knows?  I'm just wondering why they reported that they would be delivering a paper on the results at the AUA conference and then apparently did not.  (Unless of course my source just missed the meeting, but I doubt that).

My urologist is Dr. Lipshultz at the Baylor College of Medicine in Houston, which is one of the trial sites for Xiaflex. Dr. Lipschultz has a PA who oversees clinical trials and he told me that many of the Xiaflex trial patients had very positive results. He indicated that the trial was very regimented and only one injection was administered per patient during each session. The dosing was the same for every patient and only injected at the site with the greatest plaque density. The penile curvature had to be between 50 and 90 percent. He told me that almost every patient was bruised after each injection, however most noticed significant improvement with their penile curvature. He said most patients noticed a popping sensation during the middle of the night with their nocturnal erections. Just thought I would pass this along for those of you curious about Xiaflex.

Quote from: ohno on June 11, 2010, 12:35:58 AM
Joe, is there anyway to find out whether you got the placebo or not? Won't they tell you? How many injections did you get and over what period? Do you think the injections didn't help (or hurt)?

They wouldn't tell me at the time, but maybe I could find out now that that phase of the trial is over.  It was a lot of injections, because every time I would get an injection of the study drug, I would have to come back at 1 week and 4 week (I think) intervals for measurements.  On those visits I would get an injection to induce an erection and then at the end an injection to make it go away.  So for every injection of the "drug" I'd receive at least 4 other injections.  I want to say there were maybe 4 cycles of this over 2 months, but I can't remember for sure.  I didn't see any change for better or worse from it.

Quote from: kendotx on June 14, 2010, 09:45:16 PM
He said most patients noticed a popping sensation during the middle of the night with their nocturnal erections.

I hope everyone realizes this is very positive news.  It means Xiaflex might actually work for Peyronie's as it's already working for Dupuytren's - by weakening the fibrotic tissue until it can be snapped.  Although an MD won't want to apply force himself and risk damage, the erection process might do it naturally.  The effectiveness of Xiaflex should increase when it's in normal use - not in a controlled trial) and MDs can inject as much as they think is needed.

I think this is - as our Vice President recently said - a BFD.

If someone could provide me with an e-mail address for Dr.Levine or Dr.Lue...I want to propose using Xiaflex off-the label for the treatment of Peyronie's. Since it is an FDA approved medication with a legitimate medical purpose, I want to find out if it can be used off the label to treat other conditions.

I would suggest you be careful about "suggesting" anything to these doctors who have speciallized in treating Peyronies Disease for many eyars now. Don't you think they would already be aware of this. Given the fact that Dr. Levine was involved in the phase II studies I think he is well aware of what Xiaflex can and can't do.

I was in the xiaflex trial and received the placebo. No change either way. For those who want to know if they received the placebo or Xiaflex, you should contact the coordinator of the clinical trial at the urologist's office where you received the injections.

One result that is very difficult to understand is that almost 1/2 of men who received the placebo - no modeling also met the end point goal. This information is on the Auxiluium site. 

My urologist made no mention of anyone experiencing a popping sound as someone noted on this forum.   

Quote from: ohjb1 on June 17, 2010, 08:45:27 PM
One result that is very difficult to understand is that almost 1/2 of men who received the placebo - no modeling also met the end point goal.

If true, that's bad news as it means the 'end point goal' wasn't based on objective measurements.  ohjb1, since you were in the trial, can you tell us how the 'goal' was defined?  I sure hope it wasn't a patient questionaire with nebulous questions about "satisfaction".

1/2 of men DEF should not have met the end point goal, is that is accurate, either the end point goal wasnt a great accomplishment, or the study has an error.  Sometimes in studies patients will imagine symptoms or improvements.  With my own peyronies the curve changes on how erect or not erect I am, and on the day. But overall I can still the hard plaque is still there, and you can tell it hasn't gotten better.  Maybe I'm assuming to much in that everyone else can tell if their bend is worsening or getting better.  The results from this study appear to be mixed, seems like we haven't gotten a clear cut YES that this work on peyronies, like we saw with DC.

Comebackid

Ohjb1 - Can you go into detail about your experience with xiaflex? The actual injections? I know it was the placebo. I'm assuming that it is injected much like verapamil (I could be wrong). If so, Dr. Mulhull told me that he was pretty sure that the verapamil did nothing but that the positive reactions could be chalked up to the solution the verapamil was in or just the swisscheesing effect. When they injected you were there multiple injections? If he's right then it would not be so strange that patients with the placebo saw improvement. I'm sorry you got the placebo and no positive results. Thanks

OhNO,

Good point on the swiss cheesing effect, I think this is a very possible theory.

Comebackid

To me the idea that the injections alone would perforate the plaque enough to make a difference is total wishfull thinking.  2 needle sticks aren't going to make the slightest impact on a mass of hard fibrotic tissue.

ohno - my experience with Xiaflex. Nothing much to say. Was given lidocaine to kill the pain.  Then had essentially no feeling when i was given the injections. Definitely more than one injection per session. Remember the dr saying that he got it right into the plaque. Again, no change either way.

if you go to the auxilium site - goal was decrease in curvature and a questionnaire. Both were an endpoint. Decrease in curvature was a somewhat objective outcome.  However, you must realize that measuring the penile curvature is not totally objective.  It can vary a few degrees with each measurement.     

Quote from: ohjb1 on June 18, 2010, 05:05:49 PM
Decrease in curvature was a somewhat objective outcome.  

Can you elaborate on this?  I agree that actually measuring curvature isn't simple.  But there's a huge difference between claiming success based on some sort of actual, repeatable - if imperfect - measurement, versus asking the patient "do you think your curvature is reduced"?  One is scientific, the other is not.  

Looks like I may have curb my enthusiasm.  The FDA just issued a warning letter to Auxilium for a shady marketing brochure which they said  "broadens the indication for Xiaflex, overstates the efficacy of Xiaflex, minimizes the risks associated with the use of Xiaflex and omits material facts."

See this article:
http://articles.moneycentral.msn.com/news/article.aspx?Feed=MY&Date=20100617&ID=11608754&Symbol=PFE

J - Urologist induces erection with injection. measures curvature with a instrument think its called a gonemometer. basically it look like an open compass. its like a high school geometry measuring device and then determines the curvature degree. There can obviously be a few degrees or more variation in this type of procedure.

Thanks ohjb1.  It seems to me like the best and simplest way to evaluate the change would be before-and-after photographs, with the camera mounted in something that enforces a consistent angle and position.  Instead they're fooling around with a protractor, trying to find 5 degrees they can claim as an improvement.   

We just need to wait for all the marketing smoke to clear.  Then some real-world MDs - who are NOT receiving checks from Auxilium - will find out what improvement can actually be achieved with Xiaflex.

J,

Excellent research to find that article, that is troubling indeed.  Although at least the government safety "police" are doing their job, if they did nothing and the drug was unsafe people would complain.  If they get to aggressive, people will say they are hampering the private market delivery of the drug.  Again we should remember the FDA is there to test safety not efficacy, so it doesnt mean the drug won't work.

The bottom line is , this drug is advancing, eventually they will have to sell it and get insurance companies to cover it, or the investors will quit buying the stock/seeing it as a good company to invest in.  As with any company, eventually they have to "turn" inventory or a product, you can't' just raise capital and do studies forever, or people will dump the stock, and capital will dry up.  I'd say the next 6-12 months we will find out if this drug is the real deal or not.  Lets hope it is!

Comebackid

I wonder about the insurance angle.  Auxilium is pricing this stuff sky high - like $3K per injection - and results apparently have been spotty.   If I were to look at this objectively, and not as a guy who might want the treatment - I'd have to question whether it should be covered by insurance at this point.  As we all know, medical costs keep climbing to the sky, and we're expecting insurance companies to hold the line somehow, and to decide what's really worth the money, and what is basically a long shot that should be paid for by  patients willing to take a chance.  If, say, only half the patients get any improvement, and the average improvent is just 5-10 degrees...

Maybe someone who knows more about the insurance business has an opinion on this.

Like I said earlier, I think the reports of "popping" sensations are cause for hope.

$3k per Xiaflex shot may seem high, but may look attractive to insurance companies in lieu of more expensive surgeries.

Oddly enough, I don't think I'd want to use Xiaflex until it has been on the market awhile. I currently have full functioning and very minor curvature; I consider my Peyronie's to be more of a cosmetic issue and a psychological burden. I might have a different view if I was in worse condition (or if I get worse down the road).

Even if Xiaflex isn't the magic bullet, I hope it spurs interest in other pharma companies in treating this disease.

-Skjald

J,

Keep in mind, most insurance companies don't pay that 3k price, they negotiate a "contract" rate with the doctor/imaging lab/ prescription place.  I just recently was in for a doctor visit which costed $90 for a visit. My insurance companies contract rate was $60, what they got billed in other words.  of that I paid just $4.20.  I've seen original bills as high as $545 negotiated at a contract rate of only $225.  Thats why if you don't have insurance and your paying cash as a walk in customer your getting fleeced like crazy.  Just having insurance alone even if you had to pay 100% of the costs is a better deal.  But most people only pay 10% or have some kind of a copay.  So that 3k pricetage may not be the actual billable rate.

As far as insurance companies deciding what to cover, not sure how that works, I don't know if FDA approval alone wil cause them to cover it.  There is a chance they could not cover it, or at least not right away, which then if you want the shots youll pay out of your pocket, and that full 3k price per shot. But we really have yet to see solid STUDIES showing xiaflex works well in peyronies patients, so we are getting ahead of ourselves. 

Comebackid

Quote from: ComeBacKid on June 22, 2010, 03:29:29 PM
J,

Keep in mind, most insurance companies don't pay that 3k price, they negotiate a "contract" rate with the doctor/imaging lab/ prescription place.  I just recently was in for a doctor visit which costed $90 for a visit. My insurance companies contract rate was $60, what they got billed in other words.  of that I paid just $4.20.  I've seen original bills as high as $545 negotiated at a contract rate of only $225.  Thats why if you don't have insurance and your paying cash as a walk in customer your getting fleeced like crazy.  Just having insurance alone even if you had to pay 100% of the costs is a better deal.  But most people only pay 10% or have some kind of a copay.  So that 3k pricetage may not be the actual billable rate.

As far as insurance companies deciding what to cover, not sure how that works, I don't know if FDA approval alone wil cause them to cover it.  There is a chance they could not cover it, or at least not right away, which then if you want the shots youll pay out of your pocket, and that full 3k price per shot. But we really have yet to see solid STUDIES showing xiaflex works well in peyronies patients, so we are getting ahead of ourselves. 

Comebackid

That's true.  And some insurance companies may classify it as "experimental" for a long time after it's FDA approved.

I'm sure you could attempt to lobby the insurance company to cover the product, with such an embarrasing topic to talk about, and with intense "loud" pressure, they might just say the hell with it and cover the shots for an individual patient or two.  Maybe Tim or someone who is familiar working for or with insurance companies could tell us how they decide what to cover.  My guess is the more mainstream something is made, the more likely it is to be covered.  Take for example breast cancer screenings.  Due to the womans movement on this issue, and getting loud, and pouding the issue out in the media, insurance companies who didn't cover basic screenings would be chastised, and probably just cover them.  Not to mention the costs savings for detecting cancer early. 

Comebackid

I have been a principal investigator of "experimental" drugs (mostly antibiotics) and when they have been approved as safe in a single group of people, it is far easier to the study that drug in another group of people (unless the groups are significantly different)(i.e. growth hormone for dwarfs used in tall people - a no go).

Once the FDA approves Xiaflex for use in DC, it will be used immediately for Peyronie's by some docs, and surely some studies will be done that test it against conventional therapy (whatever that is!).

Tim

People are just now starting to get Xiaflex for Dupuytren's outside of a trial.  I just read a post from a guy who got an immediate denial from his insurer - they still call it "experimental" and apparently wanted to herd him back to a conventional surgery.  But the guy persisted, kept appealing, and his hand surgeon got involved in arguing the case with the insurer, and eventually they relented.  And he had a Xiaflex treatment which he said was very successful.

Insurers have plenty of ways to make you give up and go away.  When I was prescribed (worthless) transdermal verapamil, I tried to get my insurer to pay.  I ended up on the phone futilely trying to explain Peyronie's disease to an absolutely clueless young woman who was probably writing "crazy old baby boomer with ED" on a piece of paper while she pretended to listen.  I rate that day as one of the real low points in my life.  And they never paid anything, and of course it was all a total ripoff anyway. 

For me the bottom line is that Auxilium has to do the work of selling this product to insurers so it appears on their lists and is routinely approved.  I am not going to try to do that for them.  

J,

I second your statement.  I've had it battling insurance companies to get coverage.  After awhile you just run out of steam.  Usually the claims process takes weeks upon weeks. Most recently I had a condition that on paper looked like a brain tumor but it wasn't.  Within 3 business days I got a form mailed to me from my health insurance company for pre existing conditions.  Never saw any company in my life move that fast.  I signed it the day I got it, saying this was not a pre existing condition and mailed it back the next day. Then they notified me later the form was late and the claim would not be payed.  I called them up and said how is a form late if i get it one day and mail it back th next day, thats ridiculous, I said you sent me a form and expected in back in like 7 days, what about mail time, the time it takes me to receive it etc.  Then they told me they would pay my claim, and it got paid.

Comebackid

Comebackid, your experience is typical.  Insurance companies seem to be perpetually in some degree of internal chaos.  Their big-brained bean counters created a "cost control" system that is choking on its own complexity.  They're always changing the plans, changing the rules, dropping one provider, signing up another, adding requirements and restrictions.   It's up to the patient to sort everything out, find the errors, demand the corrections, appeal the wrong decisions.  It's all driven by you.  

They are masters of passive resistance.  

I think things have gotten a little better in recent years.  We seem to be able to call our insurance company, ask a question and get a coherent and correct answer from someone who doesn't sound like they were hired last week.   Not always, but usually.  

J - I might have misunderstood you. Are you saying there is a post somewhere about someone getting xiaflex treatment for peyronies off label? If so, would you mind telling me where I can read this post? Thanks

I was in the Xiaflex trial and received the placebo. Just received an email from the urologist that the next phase of the trial will begin in October and was I interested. That is all there is to the email. Does anyone know more about this?

It could just be a matter of wording, but i thought that the company would say that since i received the placebo, in the next phase would get Xiaflex. Am not sure if that is what is going to happen or if they expect me (and others) to again receive the placebo or xiaflex. If so, I will not participate.

I assume there will be many more trial sites and hopefully one closer to home. 

Quote from: j on June 28, 2010, 07:20:49 PM
People are just now starting to get Xiaflex for Dupuytren's outside of a trial.  I just read a post from a guy who got an immediate denial from his insurer - they still call it "experimental" and apparently wanted to herd him back to a conventional surgery.  But the guy persisted, kept appealing, and his hand surgeon got involved in arguing the case with the insurer, and eventually they relented.  And he had a Xiaflex treatment which he said was very successful.

Insurers have plenty of ways to make you give up and go away.  When I was prescribed (worthless) transdermal verapamil, I tried to get my insurer to pay.  I ended up on the phone futilely trying to explain Peyronie's disease to an absolutely clueless young woman who was probably writing "crazy old baby boomer with ED" on a piece of paper while she pretended to listen.  I rate that day as one of the real low points in my life.  And they never paid anything, and of course it was all a total ripoff anyway. 

For me the bottom line is that Auxilium has to do the work of selling this product to insurers so it appears on their lists and is routinely approved.  I am not going to try to do that for them.  

I went through the same crap trying to get Cigna (In The Business Of Caring ...NOT!!!).  They finally wore me down and I just bought one from Fitzz.  So their method works.

If I wasn't gauranteed the actualy drug in a second round of trials, I would not do it either.  To many unnecessary injections and bruising.  I would demand the drug or not participate.

Comebackid

Quote from: ohno on June 29, 2010, 09:23:04 PM
J - I might have misunderstood you. Are you saying there is a post somewhere about someone getting xiaflex treatment for peyronies off label? If so, would you mind telling me where I can read this post? Thanks

No, the case I described was Xiaflex for Dupuytren's.  It's approved for Dupuytren's so it's use is not 'off-label'.

so why cant we buy it off label and start jabbing it into our dick??

Quote from: Iceman on July 01, 2010, 02:40:43 AM
so why cant we buy it off label and start jabbing it into our dick??

Start checking airline fares to India.  And get a good deal on a kidney while you're there.

Quote from: Iceman on July 01, 2010, 02:40:43 AM
so why cant we buy it off label and start jabbing it into our dick??

Ok there seems to be some confusion as to what 'off the label' means. You cannot BUY the medication, it is prescription only. Using a drug off the label means that a physician uses a drug to treat a condition which it is not FDA approved for. As an example, an A-typical anti psychotic like Quetiapine Fumarate is used in the treatment of schizophrenia & bi-polar, yet it is often prescribed to treat generalized anxiety disorder and panic attacks, conditions for which the medication is not approved by the FDA to treat. Or a better example would be the use of Pentoxil, we ask that to be prescribed for Peyronie's, but it is not an indication that the drug was originally studied for.

Therefore, you would need to find a Urologist who would be willing to treat your Peyronie's with Xiaflex with an off the label indication. Actually, just about EVERY drug used to treat Peyronie's is an off the label use since there are no drugs that have been studied and approved to treat Peyronie's, even drugs like Verapramil are being used in an off the label indication.

I am a patient of Dr. Lue. I sent him an email last night in regards to Xiaflex being an option...here was the response:

    -----Original Message-----

    Subject: Peyronie's treatment question from patient

    Hi Dr. Lue, I hope you are doing well!
    I am one of your patients. My name is --------.  I have aggressive Plaque formation/Peyronie's disease.

    My question: Is Xiaflex an option for treatment for me? Do you know much about it or it's effectiveness? Thanks very much for your time!

    -----Response Message-----

    Xiaflex is not available to treat Peyronie's disease and we do not know when the company will start phase 3 study.

    Best regards,
    Tom

Thanks for the update Briden.

Briden,

Thank you for posting. Would you be able to e-mail Dr.Lue back, and ask him about a possible off-the label use of Xiaflex to treat peyronie's before it is done phase III clinical trials. That would be much appreciated, as I'm sure we'd all be interested in hearing his opinion on that as a possible option.

Iceman,

Your inbox is full! Just in case you didn't know that!

Comebackid

I had a yearly follow-up with my urologist Friday.  He's never been very cutting edge on Peyronie's (he begrudgingly allowed me to try Pentox for a while but then wouldn't let me stay on it (for no good reason)).  However, he mentioned to me that "there's an injection in Phase III trials now that they're having some luck with, and have had luck with Dupuytren's with it ..."  He couldn't recall the name (obviously not very helpful) but I assume he was talking about Xiaflex. 

Anyone know if he's correct about this or if he's off the mark?  I thought it still wasn't in Phase III? ...

Nemo

So, at least one peyronies expert is not rushing to try it.  That tells me xiaflex is not something we can expect to see in the immediate future, if not years.  Until some studies are complete, no one can possibly know if it is effective or not.  I think the professionals call that evidence based medicine.  For me, right now, it is just another unproven treatment which "might" work, but we really don't know.  I eagerly look forward to seeing the results of any such study.  Meanwhile, my only choice is to continue with proven treatments.  :-/ 

Its worth waiting for Phase III results in my opinion. The improvement from Phase II to Phase IIb was from 25% to 32% (with modeling). Auxilium clearly learnt something about injection site, does and application. That was a 30% improvement rate of 7% between trials. Hypothetically applying the same rate of improvement between Phase IIb and Phase III - then we could see a further improvement of 9.6% or total improvement of 41.6%.
Starts looking a bit more interesting and viable as a treatment if that happens. Hypothetical but don't see why that couldn't happen. Irrespective if Phase III is starting October, 9 months of trials and 3 months for data - takes us through to October 2011, and earliest drug to market would be early 2012. If there is a doctor willing to do off-label he won't be benefiting from the extra trial data.

My concern UK, and my push for it to be used off-label, is for newly diagnosed patients like myself. From what I have gathered in the literature, there is a critical time period 6-18 months while the Peyronie's is in the mobile phase, and the plaques are forming but have not yet calcified. Early intervention before the disease is permitted to progress fully, cause more curvature, and more damage to the tunica and other tissue in the penis is paramount in my opinion. For those of us who have just recently been diagnosed and who have a relatively mild case of Peyronies Disease, early intervention may save us a long recovery period before extensive damage is done to the tissues in the penis. In our case, 9.6% may not be a big deal, if we can intervene before the Peyronie's progresses further. This is of course my opinion, and something I'm going to pitch to my Urologist on my next visit.

Brooks mentioned that until the Phase III trials are complete, he'd just stick to proven treatments. My question to him would be, what proven treatments? There is not one single medication, device, or therapy which is FDA approved for the treatment of Peyronie's other than invasive surgery. Essentially ALL of the oral and topical medications that we use in the treatment of Peyronie's are "OFF THE LABEL" uses. We are using medications which were never designed or intended to be used for the treatment of Peyronie's, but which have measureable amount of efficacy in the treatment of Peyronies Disease. If a Urologist is willing to do it, I would have a hard time saying no based on the current clinical data.

Quote from: UK on July 05, 2010, 01:20:45 PM
Its worth waiting for Phase III results in my opinion. The improvement from Phase II to Phase IIb was from 25% to 32% (with modeling). Auxilium clearly learnt something about injection site, does and application. That was a 30% improvement rate of 7% between trials. Hypothetically applying the same rate of improvement between Phase IIb and Phase III - then we could see a further improvement of 9.6% or total improvement of 41.6%.
Starts looking a bit more interesting and viable as a treatment if that happens. Hypothetical but don't see why that couldn't happen. Irrespective if Phase III is starting October, 9 months of trials and 3 months for data - takes us through to October 2011, and earliest drug to market would be early 2012. If there is a doctor willing to do off-label he won't be benefiting from the extra trial data.

I think calcification takes a very very very long time.  Pentox studies have shown to reverse calcifications as well.  Xiaflex won't be ready for at LEAST a year, anytime before just isn't going to happen.  I'm not so sure the 6-18 month window is that important, but anytime you can get on a treatment as soon as possible you want to.  Most docs hand out vitamin E and tell you theres nothing you can do anyway.

Comebackid

Quote from: MedStudent86 on July 06, 2010, 06:14:52 PM
there is a critical time period 6-18 months while the Peyronie's is in the mobile phase, and the plaques are forming but have not yet calcified. Early intervention before the disease is permitted to progress fully, cause more curvature, and more damage to the tunica and other tissue in the penis is paramount in my opinion.

When I had an appointment with male sexual health specialist Dr. Lue last year, he said calcification takes years not months. Although I am not a medical student or health professional, my conversations with Dr. Lue and my layman's understanding of the literature is that progression of the disease is not inevitable and that there are varying degrees of this disease. My hourglassing and minor loss of length are exactly the same 1.5 years on as they were just a week or so after my injury. Granted, I did start pentox about 5 months in so that may have helped slow any further progression. Not sure if I would want injections of Xiaflex early on though. Again, just a layman sufferer's opinion.

-Skjald

Based solely on my own experience, I agree that the need for early treatment, and the fear of calcfication, are both exaggerated.   Xiaflex can only dissolve or weaken existing plaque, it can't prevent it from forming. 

Quote from: j on July 06, 2010, 10:02:34 PM
Based solely on my own experience, I agree that the need for early treatment, and the fear of calcfication, are both exaggerated.   Xiaflex can only dissolve or weaken existing plaque, it can't prevent it from forming. 

This is true. However, and my opinion is just my opinion. There is so little data available about Peyronie's and the disease process (which is not fully understood) that it makes it hard to make 'predictions.' However, my major point was wanting to avoid damage to the tunica and surrounding tissues due to the plaque formation. While Xiaflex cant prevent plaque formation, logically I would think, that if we can break up/dissolve the plaques in the early stages, and new plaques form afterwards, we can break those up as well until the penis has healed the area without the pesence of the plaque, then we are steps ahead in keeping the tunica albuginea from undergoing extensive damage, as well as any other tissue in the surrounding area that may be affected. One would also think, if you can intervene at an early stage and dissolve the plaques as they are forming in the early stages, one can reduce/eliminate the loss of length and girth that occurs as a result of the plaques causing the tissues to become constricted and regress. I am not a doctor, so do not take my opinion as if it is coming from one. I am just basing it off of the current literature and information available to me, and what I know so far. I believe that early intervention in any disease is important, especially one which can have a significant amount of potentially irreversible damage to tissues which presently cannot be replaced. I am not advocating ONLY using Xiaflex, I think that the consensus on this board is that there are several medications which help to attack the disease process at several different levels, and I think that is a good approach, but I believe Xiaflex would be a good addition to an immediate attentuation of the curvature. Then drugs like Pentoxil can be used to prevent plaque formation, and VED therapy used to regain length and girth, as well as to remodel the damaged tissue.

I called auxillium about this... their number is readily accessible and they have humans answering the phone.  They explained all of the details, and I read between the lines for the rest.   The bottom line is that you cannot get xiaflex because they have limited the distribution channels - not because it's off-label.   This is the situation...

1.  Phase 3 trials have not begun yet for Xiaflex in men with Peyronies Disease.  Recruiting the sample, alone, will take several months - not to mention the trial itself will take monts + data analysis, etc... you're looking at 1+ years here.  Remember phase 3 has to be much larger than phase 2...so it's gonna be a while.  (Some of us might be eligible to be in phase 3 btw...not sure how many bc I think calcified plaques disqualify you - but i could be wrong)  Then, the FDA will take 1+ years to review their findings.  Bottom line - Xiaflex will not be FDA approved for Peyronies Disease until 2013

2.  So, why does that matter?  Why not use it off label?  The person on the phone actually told me this before I even asked it, because apparently they must be getting dozens of questions about this.  They don't give you the real answer (which I will provide below - per my own speculation) but this is what they say:  You are ONLY allowed to get xiaflex if you are an orthopedic surgeon or surgeon of the hand who has completed a training course in xiaflex injections.  Orders from urologists or any other kind of doctor will be denied.  Every order is reviewed & every hospital site that it is going to is also reviewed.  They don't just cash the check & send it out.  (I asked, what if I signed a waiver of liability - but this was not a question she could answer... this was a largely scripted conversation).

3.  If you wish to pay out of pocket for 6 xiaflex injections, you will have to find a hand surgeon who will order it and then give it to a urologist who knows how to inject it (and it's extremely specific & has some complex measuring formulas for DP on the website - since it is reconstituted from a powder & you don't want to over-inject and dissolve too much collagen, etc).  This will cost approximately $18,000 - not counting the office visits.  And, the results are not guaranteed.  But it is unlikely anyone will find a hand surgeon who is going to order it for you & give it to a urologist.  And also,  if you submit it to your insurance, it will not be reimbursed since it is not approved for Peyronies Disease.  

So, why is Auxillium guarding this drug?  Well, the cynical answer is they are concerned for our safety their future profitibility.  If a bunch of doctors start using it off-label (and without the highly specific training needed -- which they cannot legally provide) and people with Peyronies Disease have negative reactions, then (a) that data will become public in the grapevine & possibly even in journals - leading less urologists to use it when it does get approved  (b) the FDA may consider negative reports of off-label use in the application process (b) auxillium may get sued for complications from xiaflex in Peyronies Disease if they happen - and it is likely to happen if 100s of urologists are using it off label who are not perfectly trained.  They don't want to be pulled off the market (e.g. vioxx) before they are even allowed on the market.   Also, if they knowingly send it to urologist offices (this drug doesn't get stocked at walgreens) then they are implictly saying "we can do what we want - screw the FDA".  Then, when this becomes public in a scandal like the Neurontin-for-everything controversy that happened in the late 90s, they will end up in litigation, like Parke Davis was (Pfeizer, their parent, lost $430 million...which is 1/2 of  auxillium's entire market cap).  Granted, the Neurontin promotions were completely insane & clearly illegal - so they deserved that judgement - but selling xiaflex to a urologist would really only send 1 message to the judge - and it's not "we thought the urologist was using it for DP!".

They are a very small company with ONE product that they want to charge a ton of money for, so they are watching it like a hawk.   Also, given their size, they may not have the capacity to produce the drug for DP and Peyronies Disease at this time (which is common with some new drugs - where doctor friends of mine have told me they have to go through similar hoops to get the drug - like certain things in neurology recently & oncology - hard to produce & hard to get).

Anyway, at the moment, it would likely be easier to get heroin and crack than to get xiaflex.  Even if you got a bottle, nobody would know how to inject it, since the measurements & process for the penis are not public (the DP measurements are in the training videos on their site).  The powder expires rather fast & also when it is reconstituted with saline, it is only good for <1 hr.  Last, only the doctors in the trial know what the theraputic dose is for injection.

Well, sorry to disappoint you all but I hope this clears things up.  If you read the posts here,  you will find one of the the very few guys on here that had xiaflex said it didn't work that well for him (he was not in the control group) & he went on to later have grafting & excision surgery.

Anyone interested in a technical / legal analysis of off label prescribing can read more here.  http://leda.law.harvard.edu/leda/data/638/Kaufman.html

Oh, and it looks like Auxilium grossly overestimated the population of people with DP and their stock just got hammered... So, perhaps they'll move their ass on Phase 3 for Peyronies Disease where they will likely find much greater profits.

http://online.barrons.com/article/SB50001424052970203296004575324902997001566.html?mod=BOL_hpp_popcomment

To MedStudent86
You mentioned the terms early intervention and Xiaflex. I was in the Xiaflex study and received the placebo.
Note that Auxilium specifically excluded those men recently diagnosed. I don't remember the exact time frame, but you could be not be newly diagnosed and receive Xiaflex in the trial. Whether the protocol will change we will have to wait.

I'm not to worried about the FDA, could they move faster?  Perhaps?  But eventually they will either clear the drug for use or not, I'd rather have them take their time and make sure its safe, I got loads of pentox upstairs to take until then, which is more proven to work than xiaflex.  Could they abandon the drug for peyronies? Perhaps, but they are pretty far into this now, but yoru right, companies don't create a product cause they feel bad about mikesmith, while some might, they also do it to make money.  To make money you have to have demand for a product or show demand to raise capital, in order to justify making a supply.  How can we help them show demand? Starting mailing to every urologist in the usa about the PDS, and encouraging patients to seek support here and sign up for an account.  By doing this we grow our membership, increase our credibility, and allow us to reach out to xiaflex and not be ignored, we also provide them with information they can show to shareholders that there is a demand for this product. Consdier joining the mass mailing project and getting involved today.

Comebackid

So now the question is how do I / we get notified to get on the phase 3 trials list?  Where do I sign up? Is there a waiting list?  Does my doctor need to sign me up? Thanks in advance

I talked to my doc about getting in on the trial.  He said he would check and see if I could and how far I would have to travel, etc.  That was 6 weeks ago though and I haven't heard anything.

I just talked to someone at Urology Centers of Alabama in Birmingham and was told that the Auxillium trials were scheduled to be conducted there.  My contact did not know the term "Xiaflex" but did say Auxillium, so I assume it's the phase 3 Xiaflex trials.  You can reach them at urologycentersalabama.com

Thanks for the info Fred. Let's hope that there is light at the end of the tunnel as far as Xiaflex useage for peyronie's patients is concerned.

FYI, You can search for clinical trials on the government website: http://clinicaltrials.gov/

If you search for peyronies (http://clinicaltrials.gov/ct2/results?term=peyronies), the first result is the Auxillium trial (I believe that was Phase II) that is now completed.  It still shows the original criteria there.  I assume when Phase III is planned it will also be listed there.  There is a Botox study currently recruiting participants.  :-\

We have talked about reaching out to Auxilium with a letter as part of our outreach campaign, what do you guys think?  I was thinking about the new year would be a good time to send one out, by then they should be well into the Phase III trials.  Seems like still a lot of lingering question marks regarding Xiaflex, it'd be nice to get some concrete answers for our members.

Comebackid

What about if every man and significant other wrote a letter to Xiaflex just to let them know how many of us are out here.  It would only cost 44 cents a person and they might be surprised how many of us there are.

If you think it's a good idea, just post an address for us and maybe write a form letter for us to follow.  I bet we could overwhelm their PO Box.

GS

Quote from: GS on August 24, 2010, 08:38:50 AM
What about if every man and significant other wrote a letter to Xiaflex just to let them know how many of us are out here.  It would only cost 44 cents a person and they might be surprised how many of us there are.

If you think it's a good idea, just post an address for us and maybe write a form letter for us to follow.  I bet we could overwhelm their PO Box.

GS

Great idea!  Who knows the address?

Gs

Sounds great ,Comebackid has gone to great lengths generating a letter for this purpose and sending it out.
I think creating your own letter describing your own suffering will bring a better response comapared to a form.To me looking at a form is just another number writing your own letter to Santa creates more emotional attatchment making your words stronger.

We are society and not just one.Combackid cannot do this on his own we have to come together on this.
I for one would like to see a fund created for research bearing our name Peyronie's scociety.To be used when there is a reputable research organization that we can vote on and accept as worthy to our cause.

Just my 44cents :fubar, if 4000 of us sent a letter total cost 1760.00$ .

Gs,

I like your creative idea of every person sending a letter to Auxilium, it would really send a message flooding their P.O. Box.  However with that being said, we couldn't even get 10 people to participate in our mass mailing project, asking everyone to send a minimum of ten letters out.  I wouldn't want to follow through with this great idea if only five of us sent letters, it would make us look like a joke.  I'd have to see a list with people vowing to send a letter.  If you want to send your own as fubar says, it can't hurt.  I just thought a general one from the PDS would be a good outreach sooner or later.  I'm open to any ideas at this point. Fubar, your idea sounds good, although I don't know much about how that would work for taxes, who would control the bank account holding our money, etc.  I know Hawk has said he has experience working on local government and possibly budgeting issues.  Perhaps he or an account could chime in and discuss how you would set this fund up, who would control it, what we would do with it for tax purposes, how would we give out money or grants, and to who, and who would decide, all of us? I would imagine such a fund would be a 503 c, non profit like our organization, wouldn't it just be like the pds bank account?  I don't think it would be a separate fund, it'd have to be through us.  I think some would be suspicious of asking for money.

Comebackid

I may be over simplifying the issue, but it looks to me like you could just post Auxilium's address with a person's name to send the letter to.  Maybe you could also write a sample letter for us to use as a prototype.  Then we can all write our own letters and send them to Auxilium.

After we send our letters, we can post that we sent it and we would all know how many were sent.  Maybe you can set up a separate thread that we could just add our forum names to.  It would only cost 44 cents a man.  I know my wife would also send a letter.  She would like to see me cured as much as I would like to be cured.

I would also be more than willing to donate money to our cause.  Just let me know how you all want to proceed and I'll do my part to help.

GS

GS

I applaud your enthusiasm that we have been lacking for advocacy and outreach.  If you want go ahead and draft a letter to be mailed to Auxilium, we can try getting as many people to send one off as we can, but I don't think we will get enough people.  As for a fund involving money, I think we should hear from the administrators and the PDS Advisory board on that issue before we move forward with such a task.  Also other members, perhaps a CPA or someone involved in finance or accounting. 

Comebackid

Quite frankly, I am probably not the one to actually draft a sample letter for our forum to follow.  I'm sure we have much better and more knowledgable people than me on this forum.

I'm guess I'm suggesting the advisory board draft an outline of simple bullet points that we can incorporate in our individual letters.  Also, we need to have some way to figure out how many letters actually get sent.

To all of our members; remember this:  Peyronies is not going to cure itself.  We need help from the drug/medical community and anything we can do to solicit that help is important to all of us.  Let us all hear your thoughts on the subject.

GS

I can write my own letter if someone can provide me with the address.
Fred

GS,

Your absolutely right, we need group participation, peyronies will not cure itself.  Thats why I'm undertaking mailing the entire USA essentially for the mass mailing project.  Our lack of participation has been poor on the forum, and kind of disappointing to be honest.  Auxilium is working on an exciting product, I would hope your idea will generate more interest then has been shown thus far. Right now I am committed to finishing the mass mailing project and it takes up much of my time, keep in mind we also sent a letter to Dr. Atala which I sent as well. So we are reaching out.  I'd love to hear from the PDS Advisory board on this topic before we move forward.  Perhaps sending them a PM and asking them to contribute to the discussion would be helpful.

Comebackid

GS,

I wanted to point out that through June, July, and August, (92 days) we had 304 new members or 3.30 new registrations per day.  Our current average I believe is like 2.1 so our membership is up, I do believe the mass mailing project is starting to kick in at this point and increase membership, since we've been mailing since last October.

Comebackid

FYI to all,

I thought I would do a little research on how the Xiaflex phase 3 trial is coming along, so I called Auxilium Pharmaceuticals today to check it out.  They have a toll free number listed on their website.   According to the lady I talked to, they haven't started phase 3 yet, but she thought they were close.  She didn't know how long phase 3 would last, but said they would be keeping us all posted through their website and it would be posted on clinicaltrials.gov.

She asked if I wanted to be on their mailing list and I gave her my name, address and phone number.  I really don't expect to hear anything, but if I do, I will certainly post whatever information they give me.

Bottom line...IMO,it's a complicated process and it's gong to take some time.  Another year or two?  No one seems to really know.  Keep the faith...I'm sure they are going as fast as they can...after all, they don't make any money from it until we are buying it.

GS

Good work GS!  Definately keep us posted if you hear anything, as I expected they are moving along, but it could be another year until this product is brought to market.  Your absolutely right, as far as I know they will not make any money until they bring it to market and sell the product, so they have an incentive to get it right, and not piss away money they raised through issuing shares.  What is their stock symbol do you know?  They probably are being cautious to make sure they get it right for FDA approval, if the study is compromised they'd have to redo it, I'd rather have them take their time and get it right. 

Comebackid

Does anyone have any idea when phase 3 will commence?

I think within the next 60 days. I saw my urologist on Monday, and was asked if I was interested in participating, I declined.
Jayhawk.

I just completed the Botox trial (very pleased with the results) and the doctor at Baylor told me they would be recruiting the the phase III Xiaflex beginning in late October with the trials beginning after the first of next year.  They participated in the Phase II.

Can you go into a little more detail about how you were pleased with your results?  How bad was your curve before?  Did it improve?  Did you gain back any lost size if you had lost any?  Botox seems like a wild thing to inject into the penis.

Comebackid

http://www.prnewswire.com/news-releases/auxilium-pharmaceuticals-inc-announces-initiation-of-xiaflex-phase-iii-studies-for-peyronies-disease-104692709.html

Our late stage global development plan for XIAFLEX will consist of four clinical studies and will be known by the acronym IMPRESS – The Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies.  There will be two randomized, double-blind, placebo-controlled phase III studies, which are expected to enroll at least 600 patients at approximately 70 sites in the U.S. and Australia, with a 2:1 ratio of XIAFLEX to placebo.  There also will be one open label study, which is expected to enroll at least 250 patients, at approximately 30 sites in the U.S., EU and New Zealand, and one pharmacokinetic study, which should enroll approximately 16 patients.  XIAFLEX will be administered two times a week every six weeks for up to four treatment cycles (2 x 4).  Each treatment cycle will be followed by a penile modeling procedure.  Patients will be followed for 52 weeks post-first injection in the double-blind studies and for 36 weeks in the open label trial. 

The trials' co-primary endpoints are the change from baseline in the Peyronie's disease bother domain of the Peyronie's Disease Questionnaire (PDQ) compared to placebo and percent improvement from baseline in penile curvature compared to placebo.  The PDQ will have at least three domains, which will include Peyronie's disease bother, severity of psychological and physical symptoms of Peyronie's disease, and penile pain.  Safety measurements will include adverse event monitoring, immunogenicity testing and clinical labs.

"We are encouraged by the clinical profile of XIAFLEX, which emerged from our earlier phase IIb clinical trial in Peyronie's disease.  XIAFLEX was well-tolerated and produced clinically significant reductions in both penile curvature and disease bother," said Dr. Jim Tursi, Auxilium's Vice President of Clinical Research & Development.  "Over the last six months, our team, in conjunction with the U.S. Food and Drug Administration (FDA), outside experts and men with Peyronie's disease, has spent a considerable amount of time and effort to refine the PDQ, which has now been accepted for use in the phase III clinical trials by the FDA's Study Endpoint and Label Development (SEALD) Division."

So bottom line is that this study won't begin until the beginning of 2011 and last most of 2011 with final results in the beginning of 2012?  At this point all phases of studies will be complete right?  So realistically this drug if it ends up working will be available in about a year and 5 months or so?

Comebackid

I actually took the time to listen to the webcast.  It was basically pretty dry, esp. the part where investors call in at the end and ask umpteen questions.

I'd like more info on the effectiveness of the drug for sure.  According to their numbers: in phase 2b (already complete) patients receiving the drug had an inprovement in curvature from an average of 54.7% curvature to 37.2% curvature if they had 'modeling' done after the injection.

While that sounds promising, I'm not so sure it's gonna be the cure all to some with peyronie's. It'll be interesting to see what the difference is in improvement with more doses.

Nice to hope that it might be an alternative to surgery, but I think I'll wait till the final tally is in before I get any hopes up!

BSSS

Modeling is when they manually bend the penis with there hands usually in the opposite direction of the bend or curves in ones unit. Some doctors try to do it after Verapamil injections too. I believe they derive the theory from that the injections weaken the plaque and the bending will or could break the weaken plaque helping to lesson the deformity.

From my experience trying to bend my penis and feeling the plaque, I don't see how this would work, but in conjunction with a VED of slow stretching and training the penis to straighten could.  I think the VED and xiaflex could be used in conjunction to get great results!

Comebackid

Quote from: ComeBacKid on October 14, 2010, 07:39:03 PM
From my experience trying to bend my penis and feeling the plaque, I don't see how this would work, but in conjunction with a VED of slow stretching and training the penis to straighten could.  I think the VED and xiaflex could be used in conjunction to get great results!

Comebackid

They seem to favour Xiaflex and traction, but maybe that's down to there being more traction research at the time. Now that we have positive VED too, it's certainly something that could be considered I think.

was in the prior stage xiaflex study. as it was explained to me is that modeling would help distribute the xiaflex throughout the plaque. whether this is an effective approach or just wishful thinking remains to be seen.

looks like the next phase of the trial has been posted:

http://www.clinicaltrials.gov/ct2/show/study/NCT01221597?term=peyronie%27s&rank=1&show_locs=Y#locn (http://www.clinicaltrials.gov/ct2/show/study/NCT01221597?term=peyronie%27s&rank=1&show_locs=Y#locn)

I've already emailed one clinic to ask about more detail.  Will post when I hear back.

BSSS

Quote from: ohno on October 14, 2010, 08:53:59 AM
Anyone know what their "remodeling" consists of? (technique and duration ?)

taken from the clinical trials.gov page:

the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature).

question - if I sign up to this trial will i get the real xiaflex or a placebo - what are the risks involved - if i get xiaflex has any one had any positive results to let me know and if they have had the placebo what has been the side effects - what is the risk involved here as its in my city and im interested.......

thanks

it is interesting to see that the clinical trial stipulates that you are not to use  - nor have you used 2 weeks prior - any mechanical devices (traction, VED?) during the trial.

iceman. i was in the trial and had the placebo. This is a blind study. Neither you nor your dr will know who gets the drug or placebo until after the study ends. Assignments are made at random.

Of course, everyone is different, but the only side effect for me was some pain and discomfort and a badly bruised penis for a week after the injections.

No change in my conditon either way.

I just saw my urologist this week and he was able to get me enrolled in the study. I go back 11/22 for the initial evaluation. As long as I don't have any calc and my blood work is ok, they will start the injections. I hope I don't get the placebo.

This is now more than once I've heard someone mention not having calcification, meaning if they have it they aren't eligible for the study!  I wonder why this is, since we know even calcified plaque could be stretched by the VED, although it would take longer for sure.  And we know pentox can reverse calcification, I've seen some of this, but still have a "harder" than normal penis. 

Comebackid

Comeback, I think you answered your own question.  The study is for only 4 sessions at 6 week intervals.  If it took longer the results would likely not help them.

I am new to the forum but have been passively observing for awhile.  I was asked by my urologist to participate in the study.  I have two reservations about it:

1) I am presently around 11 weeks into my first VED protocol and am starting to see a very slight improvement.  If I join the study I will have to halt the VED protocol for around 6-12 months.  I am concerned I could be gambling either way since neither is a sure thing.  I feel like the VED has more testimonial evidence to support it but the study may be a unique opportunity.  I am leaning towards doing the study since I could always jump back to the VED once it is compete.

2) There is a 33% chance I would receive the placebo.  However, it states that "Subjects randomized to placebo may receive open-label AA4500 treatment after completing this study as part of another protocol".  I will decide next week and it will likely depend on what this statement means.  If I am guaranteed the real Xiaflex injections after the study if I end up in the placebo group I will very likely participate.

Turbo

good luck Turbo with your decision.  I still haven't heard back from the office close to me re: the study.

Say, I did a search on collagenase and found a forum run by a drug manufacturer.  Is anyone familiar with this place?

http://www.biospecifics.com/DNForum/default.aspx?f=6 (http://www.biospecifics.com/DNForum/default.aspx?f=6)

I hope my posting the link doesn't violate any rules, if so please remove! 

BSSS

Quote from: BSSS on October 21, 2010, 02:21:30 PM

good luck Turbo with your decision.  I still haven't heard back from the office close to me re: the study.

Say, I did a search on collagenase and found a forum run by a drug manufacturer.  Is anyone familiar with this place?

http://www.biospecifics.com/DNForum/default.aspx?f=6 (http://www.biospecifics.com/DNForum/default.aspx?f=6)

I hope my posting the link doesn't violate any rules, if so please remove! 

BSSS

well, after checking into this 'forum' a little more, I see it's not very active and not much help at all.  Sorry for the distraction!

BSSS

well I did hear from the clininc in my home state that is one participating in phase 3 of the study and they set up an appointment for me in November.

To be honest, I'm still mulling it over.  Not sure I want to 'expose' myself to more people and have a needle injected into what penis I have left.

Will post decision/results later.

BSSS

About two weeks ago I read here about the Phase 3 study for Xiaflex/AA4500.  After checking the ClinicalTrials.gov website, I called the POC for my state and "signed up".  My initial appointment is this week.  I presume if all my tests go well (and I expect them to) I'll be enrolled in the study.

With my chances being 2 out of 3 to get the real drug, I guess that's not too bad.  Plus, just like Turbo said he was, I was given assurance that anyone receiving the placebo in this study will be given Xiaflex later if they complete the study.  (I presume this will be in writing.)  From reading the comments here of the Phase 2 participants, they were offered the same thing also. 

On the downside, I'm not real happy about someone sticking a needle in my penis.  I'll get a chance to experience that on my initial visit although it will be for a different reason.

I will, as others have in the past, keep this forum advised of my experiences in the study.

Humorous

I have two concerns regarding xiaflex.  One is will it actually work, to date we have yet to see some serious results to get excited about.  The second is will the insurance cartel industry actually cover it?  You know they won't want to cover an expensive treatment, and will find a bs reason to deny it and direct us to some other method of treatment that doesn't work.  I think we should be cautious until we get to excited.

Comebackid

have you seen the study exclusions?  it's insane.. i dont know how they are gonna find anyone...

no calcified plauqes is 1 huge problem.  though there is a statement about calcification being ok under certain circumstances, but it's not clear. 

i dont know why the woman on the phone at auxilium told me phase 3 was like 2 yrs away...it's starting next month.  approval might be a year (or more) away, but phase 3 is here.

as far as insurance not covering it... i think that'll be interesting for auxillium too because they want to charge $2000 per injection & no patient is going to come up with that cash for 6 uncertain injections.  they'll have to lobby the insurance cos more than we will... if they want to make a profit.  the MS drug injections are similarly priced, btw... and newer chemotherapy agents are way way more... though these are both life or death situations & people dont seem to think Peyronies Disease is as serious as it is for a person's life. it'll be interesting who makes this decision.

I decided to go ahead tomorrow and be assessed by the local clinic that's participating in the trial.  If anything interesting occurs, I'll be sure to report!

BSSS, good luck w/ it.  Also, can you let us know if they do an ultrasound on you?   I am a little annoyed about the calcification exclusion (which can only be determined via ultrasound).  Also, when was your onset?  They want people < 1 year since onset... which is highly restrictive.

My lab test results went well.  The other tests, ultrasound, Doppler ultrasound, EKG, apparently went well also since I was accepted into the study.  The ultrasound is done while the penis is flaccid.  The  Doppler ultrasound is done while the penis is erect.  This test measures blood flow in the penis.  Then they measure the degree of curvature using a goniometer (a ruler that measures angles) to determine curvature severity.  (The minimum and maximum angles are given in the AA4500 study details.) 

Since the penis must be in an erect state for the Doppler ultrasound, and it is a drug induced erection, this is where the needle comes into play.  My biggest concern was the papaverine injection.  It was slightly painful going in and coming out but not at all as bad as I imagined.  Another thing that eased my mind a little was learning papaverine is used by some men as an ED treatment.  I thought if they use that instead of Viagra, how bad could it be?  Additionally, the needle gauge is pretty small. 

Another thing to mention concerning injections is they will offer you anesthesia via injection.  It didn't seem logical to me to get an injection to prevent pain during another injection.  In other words, if the first shot is going to be painful, why opt for two shots? 

Bottom line, I will start my first study treatment cycle very soon and I am looking forward to it. 

To those thinking about joining this study, consider enrolling sooner rather than later.  You don't know how many people will be allowed to enroll at the nearest location to you.  Slots will probably fill up fast. 

Humorous

Quote from: MikeSmith0 on November 11, 2010, 07:36:49 AM
BSSS, good luck w/ it.  Also, can you let us know if they do an ultrasound on you?   I am a little annoyed about the calcification exclusion (which can only be determined via ultrasound).  Also, when was your onset?  They want people < 1 year since onset... which is highly restrictive.

Mike,
You may want to reread the study criteria, especially Exclusion criteria 5.  To me it says if you have so much calcified plaque that they can't inject the study medication, then you will be excluded.  I don't see where it says you will be excluded if you have any calcified plaque. 

Considering the timeframe, Inclusion criteria 3 says to me your Peyronies should have started over one year ago.  In other words, your Peyronies should have stabilized before your first injection. 

If you haven't already, please read my previous message which addresses your question about the ultrasound tests.  I hope all this helps. 

Humorous

Yeah - I didn't cite it correctly in that post...I may qualify but will not know until after the 1st exam.  

Was your erection normal when you had the papaverine?   The doc injected me with that and I had the most bizarre erection which was far from 100% full, and the study excludes people under 30 degrees of curve.  When i am not fully erect, I am under 30 degrees of curve (it worsens as more blood goes in).  And I dont think I can be in the study if I cannot get erect from injected medication.  I'm fine w/ viagra - or even without it - but that injection really burns (to me at least) and is extremely awkward.  

Most of the centers don't seem to be taking appointments yet.  I called one, but I went through like 200 questions and now im gonna get called back at some point in the future.  So, I called another office and the same exact thing happened.  

Do you understand their exclusions around sex?  Like, you have to have a regular sex partner... but can you be using viagra every time?  Or, is that exclusionary?  

I just noticed that the consent form says they will only treat *one* plaque.  I have a lot more than one... I almost don't think I see the point in going through this (up to 19 visits to the office over 1 year - 4-5 ultrasounds in erect state, etc...) for 1 plaque... do you have more than 1 plaque?

I was in the prior phase of the Xiaflex trial. Received the placebo and the result was no change. I think many readers on this site are getting their hopes unrealistically high. There is no evidence that Xiaflex will be a cure or almost cure for our disease. Just look at the results posted on their websiste. At best, it may end up being an modestly effective treatment for some men with peyronies. Nothing more.

A new exclusion for this phase of the test is an hourglass deformity.  This seems absurd because almost all men with Peyronies Disease have this deformity. The participating urologist will certainly need some discretion or else will not be able to enroll anyone.

Remember, that Auxilium is an extremely small drug company with ongoing financial problems and probably is unable to design a state of the art clincal trial protocol.

ohjb1 - I've been following the Xiaflex story for sometime - Whilst I don't think that it will be the answer to everyone's problems, I think the followers of this forum should be able to derive some comfort from the fact that there is an alternative to surgery that has progressed to the final stage of FDA testing ... Having read a number of related forums and watched online treatment videos, the drug works well with Dupuytrens patients in terms of breaking down and softening scar tissue - why not be optimistic for Peyronie's sufferers ...

In terms of financials, Auxilium is not in anyway dissimilar to other developmental biotech businesses in respect to the way that it finances the development of its products ... The company has a market cap of $1.2 billion and Pfizer has put down cash for distribution rights in Europe ... The parameters of the tests are clearly designed to provide clear and consistent results when it comes to FDA sign off if it gets that far ...

This condition alone is depressing enough thanks - Taking into account your points, I for one am looking ahead over the next 18 months with some optimism about this product ...

Quote from: ohjb1 on November 16, 2010, 05:05:56 PM
A new exclusion for this phase of the test is an hourglass deformity.  This seems absurd because almost all men with Peyronies Disease have this deformity.

Agreed - did you have hourglassing before?  Somehow my horuglassing got better on 1 side...so now it just looks like a dent.  I have no idea if the uro is gonna exclude me for that. 

It only works 40% of the time in the hand contracture disorder...so yes, our hopes may be too high...

My biggest fear is this "penile fracture" in the consent form.  What is THAT?  I mean, how do you repair that?  In the Duputrynes (i cant spell it) - there were people who needed immediate surgery after xiaflex caused some kind of breakage / tendon tears as well. 

Wow.......Penile fracture is listed as a complication! Thats when the TA ruptures due to too much bending force on the penis during erection. " this usually happens with woman on top man slips out and woman comes down striking the penis with her pelvis etc."  Usually the penis goes limp immediately then the pain and the blood from the erection come up from the TA causing bruising swelling etc. It requires immediate medical attention. They have to drain the blood from the penis thats leaked from the TA, deglove the penis and repair the rupture or hole in the TA with stitches. Once the hole is repaired they induce a erection with saline to make sure everything is sealed up and theres a straight erection etc. Then they close the degloving incision.

If one does not seek immediate medical attention the condition usually turns in to Peyronies Disease & deformities of the penis.

I can see why they are warning this as a possable side effect from what I ve read about Xiaflex and Dupuytren's contracture. The doctors were giving the injections for a certain amount of time then when the scar tissue became weak they would pull swiftly on the effected finger snapping the scar tissue. Kinda like a rubber band thats been pulled past its limit. So in that regard I can see it weakening the plaque(s) in the penis then someone having an erection and it snapping the scar tissue in the same manner since the tissue in both conditions suppose to be so similar.

Also I remember hearing reports from a few guys in the last round of testing experiencing popping sounds or feelings during erections after they were treated for a little while. So I guess depending on a number of factors its possable. Plaque size, location, erection & or VED strength, etc etc.

Thanks for the info...well, that is pretty scary.  They told me that they are doing 2 injections per week + 1 session of "modeling"

Sex and masturbation are to be discontinued for 2 weeks after the injection and modeling.  I guess this would also decrease risk of fracture since it seems like a fracture can only occur in an erect state.   Then there is a 4 week wait, then 2 more injections and more modeling. 

I hope the modeling isn't like a swift "pull" or something... that seems a little scary.

I asked about the snapping noises. They said that the cracking / snapping sound is supposed to be a good thing - since it means the scar tissue is degrading.  Maybe it's the excess collagen plaque separating from the TA or something?   

I've completed the first two shots of Cycle 1.  The first one went well.  After the second shot I waited the required hour and, since all was well, left.  Within the next hour my penis started swelling and turning dark red.  Later on it was swollen about 100% and was red to dark red to purple.  I'm not sure what caused it.  However, study participants are warned about "bruising, swelling, and moderate pain".  After two days the swelling was gone. 

About a week after the swelling went away I started modeling and that's very easy, at least in my case.  I put my thumb on one side and my index finger on the opposite side (and just slightly higher than the thumb).  Then I bend my penis in the opposite direction of the curve.  Hold for 30 seconds, release for 30 seconds, and repeat that three times.  This is done in the flaccid state.  I was told I could model in the erect state also.   

Humorous

Quote from: MikeSmith0 on November 15, 2010, 04:00:20 AM
Was your erection normal when you had the papaverine?   Levine injected me with that and I had the most bizarre erection which was far from 100% full, and the study excludes people under 30 degrees of curve.  When i am not fully erect, I am under 30 degrees of curve (it worsens as more blood goes in).  And I dont think I can be in the study if I cannot get erect from injected medication.  I'm fine w/ viagra - or even without it - but that injection really burns (to me at least) and is extremely awkward. 

Mike,

My erection with papaverine was about 75-80% of normal (meaning about 20-25% less than usual).  That sounds similar to your experience.  To get into the study you only need to be over 15 degrees of curvature.  I don't think they require a "fully hard" erection or else I might not have been accepted.  In any case they will determine your angle in a scientifically measured way.  From what you've said, it sounds like you would qualify. 

Quote from: MikeSmith0 on November 15, 2010, 04:00:20 AM
Do you understand their exclusions around sex?  Like, you have to have a regular sex partner... but can you be using viagra every time?  Or, is that exclusionary? 

They require a sex partner later during the study when they expect you to have intercourse.  (At the Cycle 3 visit you will be given a calendar to record this.)  I believe they expect the medicine to take effect during that timeframe.  Concerning using Viagra, I'm guessing they don't mind.  If they do mind, they will inform you when they go over your medication list at the beginning of the study. 

Quote from: MikeSmith0 on November 15, 2010, 04:00:20 AM
I just noticed that the consent form says they will only treat *one* plaque.  I have a lot more than one... I almost don't think I see the point in going through this (up to 19 visits to the office over 1 year - 4-5 ultrasounds in erect state, etc...) for 1 plaque... do you have more than 1 plaque?

The way it was explained to me, they will treat one area of plaque.  My understanding is most men only have one area where the plaque is "grouped".  For example, I have one plaque which causes a curve of around 55-60 degrees.  Concerning the "4-5 ultrasounds", I can't find where they do any more after the initial qualification visit. 

I hope this helps. 

Humorous

Hey thanks for letting me know about your experience & answering all of that.   It sounds like you had the typical reaction to any kind of penile injection... with verapamil I had a lot of redness & swelling, etc... not pretty... but usually gone in 5-10 days.  Did they numb you before your shot or did they just put the drug in w/o lidocaine?  With verapamil, they have to numb you bc the needle pokes in & out of the plaque (repeatedly - to weaken it...or so the theory goes)  but it sounds like they just inject xiaflex on top of the plaque & massage it in.

Yeah, papaverine is not the greatest... I wonder if Trimix is better.  To be disqualified for an insufficient curve (due to poor erection) would be frustrating, especially when I can achieve an erection w/ excessive curve at home w/ viagra, etc...

I am now on the potential candidate list for the Phase III study w/ Baylor College of Medicine in Houston.  I won't go through the screening process until the clinic receives it's study medicines.  In reading the inclusion and exclusions, I don't see anything obvious.

Hi everyone,
I haven't posted anything in a while since I pretty much succumbed to the idea that my peyronnies wasn't going to get better. But I also developed "frozen shoulder syndrome" in my right shoulder ealier this year causing me a lot of pain and discomfort. I had to go through months of physicial therapy and in the mean time got addicted to pain meds for a while. I recently read frozen shoulder is related to peyronnies and dupuytren's which I also have a mild case of in my left hand. Anyway, I just got enrolled in the Xiaflex study and received my first injection of what I hope is the drug and not the placebo. I have a double curve, up and to the right. The worst of the curve is 47 degress. No calcifications... I think they don't want you in the study if you have calc, not to make it more successful, but to not have the calcification patients drag the results down. In other words, it would actually make the study less accurate because the drug doesn't have an effect on the calcification like it does on the plaque. By only using patients with 100% plaque, you will see the true effects of the drug. I was told I couldn't be on Viagra, but actually didn't see that in any of the paperwork, so I am not 100% sure that's true. I'm scheduled for my second injection tomorrow at lunch time, then Monday is my first modeling appt. My doc said if I am getting the drug, I will see a difference on my first f/u appt after 6 weeks.

Quote from: Chopsuey on December 02, 2010, 03:50:10 PM
I think they don't want you in the study if you have calc, not to make it more successful, but to not have the calcification patients drag the results down. In other words, it would actually make the study less accurate because the drug doesn't have an effect on the calcification like it does on the plaque. By only using patients with 100% plaque, you will see the true effects of the drug. I was told I couldn't be on Viagra, but actually didn't see that in any of the paperwork, so I am not 100% sure that's true. I'm scheduled for my second injection tomorrow at lunch time, then Monday is my first modeling appt. My doc said if I am getting the drug, I will see a difference on my first f/u appt after 6 weeks.

Interesting info... did he see people in phase 2?  That's interesting he thought you'd see results in 6 weeks... I heard it was more unpredictable than that.

They told me viagra was fine - but no sexual activity 2 weeks post injection...and no viagra the night before the prostaglandin injection.

They let people in with "stippled" calcium (little dots).  If the plaque is 100% calcified, it can't work.  Many scars (even on the skin) have small dots of calcium deposits in them.  You can see them on ultrasound but not an x-ray...they're not really significant contributors to the curve...unless there is a lot.

How did your first shot go ?  Did it hurt or anything? 

Good luck with it.  I can't believe it's 13 mos before you can even find out if you are on the placebo -- but I guess having no results would be one clue.

The Phase III study information is here:

http://www.clinicaltrials.gov/ct2/show/study/NCT01221597?term=peyronie%27s&rank=1&show_locs=Y#locn


Criteria

Inclusion Criteria

1.Be a male and be ≥ 18 years of age

2.Be in a stable relationship with a female partner/spouse for at least 3 months before screening and be willing to have vaginal intercourse with that partner/spouse

3.Have symptom(s) of Peyronie's disease for at least 12 months before the first dose of study drug and have evidence of stable disease as determined by the investigator

4.Have penile curvature of at least 30° in the dorsal, lateral, or dorsal/lateral plane at screening. It must be possible to delineate the single plane of maximal curvature for evaluation during the study

5.Be judged to be in good health, based upon the results of a medical history, physical examination, and laboratory profile

6.Voluntarily sign and date an informed consent agreement approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC). The subject must also sign an authorization form to allow disclosure of his protected health information (PHI). The PHI authorization form and informed consent form may be an integrated form or may be separate forms depending on the institution

7.Be able to read, complete and understand the various rating instruments in English


Exclusion criteria

1.Has a penile curvature of less than 30° or greater than 90° at the screening visit

2.Has any of the following conditions:

◦Chordee in the presence or absence of hypospadias
◦Thrombosis of the dorsal penile artery and/or vein
◦Infiltration by a benign or malignant mass resulting in penile curvature
◦Infiltration by an infectious agent, such as lymphogranuloma venereum
◦Ventral curvature from any cause
◦Presence of an active sexually transmitted disease
◦Known active hepatitis B or C
◦Known immune deficiency disease or be positive for human immunodeficiency virus (HIV)

3.Has previously undergone surgery for Peyronie's disease

4.Fails to have an erection which in the opinion of the investigator is sufficient to accurately measure the subject's penile deformity after administration of prostaglandin E1 (PGE1) or trimix

5.Has a calcified plaque as evident by appropriate radiographic evaluation, penile x-ray or penile ultrasound that would prevent proper injection of study medication. Non-contiguous stippling of calcium is acceptable for inclusion provided the calcium deposit does not interfere with the injection of AA4500 into the plaque

6.Has an isolated hourglass deformity of the penis

7.Has the plaque causing curvature of the penis located proximal to the base of the penis, so that the injection of the local anesthetic would interfere with the injection of AA4500 into the plaque

8.Has previously received alternative medical therapies for Peyronie's disease administered by the intralesional route (including, but not limited to, steroids, verapamil, and the naturally occurring low molecular weight protein, interferon-α2b) within 3 months before the first dose of study drug or plans to use any of these medical therapies at any time during the study

9.Has received alternative medical therapies for Peyronie's disease administered by the oral (including, but not limited to, vitamin E [> 500 U], potassium aminobenzoate [Potaba], tamoxifen, colchicine, pentoxifylline, over-the-counter erectile dysfunction medications, or steroidal anti-inflammatory drugs) or topical routes (including, but not limited to, verapamil applied as a cream) within 3 months before the first dose of study drug or plans to use any of these medical therapies at any time during the study

10.Has had extracorporeal shock wave therapy (ESWT) for correction of Peyronie's disease within the 6-month period before screening or plans to have ESWT at any time during the study

11.Has used any mechanical type device for correction of Peyronie's disease within the 2-week period before screening or plans to use any these devices at any time during the study

12.Has used a mechanical device to induce a passive erection within the 2-week period before screening or plans to use any of these devices at any time during the study

13.Has significant erectile dysfunction that has failed to respond to oral treatment with phosphodiesterase type 5 (PDE5) inhibitors

14.Has a penile Duplex Doppler ultrasound evaluation at screening that shows compromised penile hemodynamics that in the opinion of the investigator is clinically significant

15.Has uncontrolled hypertension, as determined by the investigator

16.Has a known recent history of stroke, bleeding, or other significant medical condition, which in the investigator's opinion would make the subject unsuitable for enrollment in the study

17.Is unwilling or unable to cooperate with the requirements of the study including completion of all scheduled study visits

18.Has received an investigational drug or treatment within 30 days before the first dose of study drug

19.Has a known systemic allergy to collagenase or any other excipient of AA4500

20.Has a known allergy to any concomitant medication required as per the protocol

21.Has received anticoagulant medication (except for ≤ 165 mg aspirin daily or ≤ 800 mg of over-the-counter non-steroidal anti-inflammatory drugs [NSAIDS] daily) during the 7 days before each dose of study drug

22.Has received any collagenase treatments within 30 days of the first dose of study drug

23.Has, at any time, received AA4500 for the treatment of Peyronie's disease

Hi everyone,

Had my second injection today and it went well. So far, not adverse reactions to the drug, no swelling and no redness at the injection site. My doctor was able to hit the plaque directly with the needle both yesterday and today. Yes, it hurt both times...especially when he hits plaque. Not unbearable, but you definitely feel it. I go back Monday to learn how to do the modeling correctly and then I don't go back for 6 weeks. Just to reiterate, my doctors says you will see "change" if you received the drug and not the placebo after the first phase. It may not be significant, but he says most guys do see improvement in the first phase. As long as the curve is still greater than 15 degrees, then the injections will continue. The nurse that is part of the study and takes care of the paperwork, monitoring me and drawing up the drug, says she has seen some pretty significant improvement in some guys. I just hope I am getting the drug because it's a lot of needle sticks for getting a placebo. So far I've had 5 sticks and I'm only in phase 1 of 4. I asked my doc and the nurse if there is a risk of the needle sticks making it worse and they said no. I'll let you know how things go.

Quote from: Chopsuey on December 03, 2010, 06:49:04 PM
Hi everyone,

Had my second injection today and it went well. So far, not adverse reactions to the drug, no swelling and no redness at the injection site. My doctor was able to hit the plaque directly with the needle both yesterday and today. Yes, it hurt both times...especially when he hits plaque. Not unbearable, but you definitely feel it.

Same with me... I don't think we had the real drug.  I think the swelling and pain would be a lot worse.  I started a thread for all guys involved in this to talk about it.

 I am a 62 years old healthy guy married to a young lady 15 years younger than me , was diagnosed the decease a year ago and has being
a bloody nightmare, my SEx life has gone to hell, wander if somebody could give me a tip how to cope with this tragedy, may penny is
got shorten about half the size is used to be and lumpy, there is any Pill to take or some other physical extender that work?
very much appreciated
Jaime

jaima,

There is no magic pill for peyronies, but there are a lot of things that can help you.  All of them are talked about in detail on this website and our forum.  You will just need to spend the time to explore the website and you will get a lot of good information.

I have had Peyronies for over 2 years now and thanks to this website and the information I gathered here, I am now pain free and have regained some of my lost size.

It takes time and effort, but you can improve your situation.  Good luck.

GS

I read somewhere that if trial tests of Xiaflex prove that it does indeed dissolve the plaque (or scar tissue), that still will not restore the elastin that should be there.  So, if after Xiaflex success is  shown, would one's penis still expand in an unnatural or abnormal way?

I am hopeful that if the drug does work, that it would not only rid us of our scars, but also bring back the healthy tissue that is supposed to be there.  Literally, a restoration of our penises before Peyronies.  Any thoughts on this?

This article makes sense to me. Fibrous tissue is dead penile muscular tissue. So Xiaflex may bring healthy lasting tissue to their maximum expansion but may not restore prior condition.
According to my knwoledge only stretching can create new cells. So it could be a good combo.
Xiaflex may enhance erectile function by dissolving plaque which compress dorsal nerve (frequent in peyronie's case).
I have to report some good improvement with bathmate (water ved) and traction (700 hrs yet). More girth stronger erection, more lenght, less curvature. Stretching is sometimes boring but really worth it.

I asked my doctor about this in my last visit.  He said the plaques have bundles of distorted collagen and elastin fibers together...and the main issue that causes the curve is not really a loss of elastin in the TA but the hard collagen fibers that won't let the TA expand.  Also, I think he implied that once xiaflex dissolves the collagen it will allow the body to clear out the elastin that is also damaged - and then ultimately rebuild new tissue - but this doesn't happen overnight - maybe 2-3 years or more to go thru the full healing cycle.  So, the makers of xiaflex and the uros involved in the study seem to feel that it will help the curve.  However, he seemed less optimistic about restoring size, thus making the point about elastin a viable one.  Xiaflex may help "visible" length by getting rid of the bend but it would be surprising if it helped "true" length - or girth.  I think xiaflex is a 50% solution but that's still good because a 100% solution is nearly impossible.  Anyone who figures out how to regenerate elastin would be a billionaire... just think of all the skincare creams that claim to do this (but none can really do it).

MikeSmith,

Very interesting, so it sounds like the tissue can regenerate or come back to some degree, there is definately a future in this kind of medicine and tissue research for sure. 

Ben,

Your absolutely right in that the stretching with the VED or other device is boring as hell but definately worth it, its a slow tedious process like healing a bone with a cast, but definately does work and is not a fluke!  Some tissue that is harder will take longer, after about 6 months you will notice benefits for sure.

Comebackid

In my last post I indicated I'd be starting the trial shortly, but I wasn't able to make the appt due to illness.  I do plan to contact the office again, but am not sure I'll stil be eligible there.

Will update when I know more.

To the guys involved in the study keeping us posted, thank you!

BSSS 

When I agreed to be on the potential candidate list for the Phase 3 study, I had mixed thoughts about it.  Mostly I was concerned about the possibility of getting stuck repeatedly with the placebo.  Some of the exclusionary criteria - no use of traction or VED for the duration - was also unappealing.  When the doc (Larry Lipshultz, Baylor Urology Clinic, Houston) called for the initial screening, I learned they do not want candidates who have taken pentoxifylline within 90-days of the first injection.  I do not remember seeing this in the FDA's Xiaflex study information, but it may have been there.  They are beginning their study in February, which excludes me out of this round.  I suppose it is possible they may not get enough of their ideal candidates, and slight revise their selection criteria or dates.

I know hourglassing is excluded in the candidates for this study, but I hope that doesn't mean the drug won't be prescribed for those of us who have that deformity later on.

I hope so too.  Xiaflex is really my only hope at this point.  I'm almost completely dysfunctional, mainly because of this "venous leakage".  I have hourglassing at the base and bottlenecking at the tip of my penis.  I have used a VED in the past, but stopped because I felt as if it was making things worse.  It was also just a really awkward thing to do, and I didn't have the time for it.  If I knew it definitely worked and that after a certain point I wouldn't have to use it anymore I would continue, but there are just too many uncertainties.  I haven't posted in a while, but I'm stuck inside because of a snow storm so I guess now is as good of a time as any.  I'm 31, and have been living with this for 3 years now. I have not been able to have a meaningful relationship with a woman in that time.  Clinging to hope.

Bummed

Quote from: bummedout on December 27, 2010, 05:04:53 PM
I hope so too.  Xiaflex is really my only hope at this point.  I'm almost completely dysfunctional, mainly because of this "venous leakage".  I have hourglassing at the base and bottlenecking at the tip of my penis.  I have used a VED in the past, but stopped because I felt as if it was making things worse.  It was also just a really awkward thing to do, and I didn't have the time for it.  If I knew it definitely worked and that after a certain point I wouldn't have to use it anymore I would continue, but there are just too many uncertainties.  I haven't posted in a while, but I'm stuck inside because of a snow storm so I guess now is as good of a time as any.  I'm 31, and have been living with this for 3 years now. I have not been able to have a meaningful relationship with a woman in that time.  Clinging to hope.

Bummed

That sounds pretty crappy bummed... I think you should just go and get some sex no matter what it takes. Just get the mister some touch could possibly pull you out of your funk. Pay for it, settle for it, do whatever you gotta do, just get some ass. Sorry if that sounds rude and offensive but I think it could really help you get things moving in the right way.

Yeah, we'll see.  It's all about survival right now.

bummedout......
You state that Xiaflex is you only option. Have you seen a specialist and discussed with them any other options?

Bummed
There are always options and there is what the future holds.I do not recommend having sex with a weak penis.You are not the only one on the forum that his this problem as I suspect I do do to. Sometimes they are strong other times they are weak.No cowboy stuff for sure as someone coming down or move you in angles and push against  the hour glassing and break you at eigther side causing more trauma and scarring.
If you are consideing a partner I would take controll of the sex so nothing would harm me.

Be safe and protect yourself but find pleasing the other important.So you can come out of the experience in in a good and successful way.Respecting the other and yourself and having a great experience.

Take safe care and action in what you do respect others and yourself!


PS: I do not think xiaflex is a remedy,  maybe a step forward as men in science may want to contribute for of fearing this may happen to them.Hard to care if you are not inflicted? Right?



Fubar

The urologist I'm seeing now told me he believes that Xiaflex really will be the most significant thing that is going to work for the majority of men.  However, he said he couldn't get me in the study since I have just acquired Peyronies and am in the early acute phase.  He said my plaque is also in a difficult area to target it.  Not sure if that will change but hope so.  I really feel optimistic that there will be a cure eventually.  Dont like it when I read other doctors say it is incurable such as on menshealthpd.com website forum.  I think it's more accurate to say that no cure exists right now. 

Restore,

I agree, while I'm skeptical of just about everything I hear and investigate it the best I can, I think some are being to negative with this drug.  I think each case of peyronies is different and unique and this drug may work very well for some, while not working well for others, only time will tell really, we all just need to be patient.  As we move into the new year and the final phase of trials for this drug( I feel like I've said this three times already) we should get some solid conclusions by the end of spring I'd hope... Does anyone know when this next phase of trials is set to be done with a final study out on it?

Comebackid

Quote from: ComeBacKid on December 28, 2010, 02:29:41 AM
Does anyone know when this next phase of trials is set to be done with a final study out on it?

From the study, March 2012 - more than one year from now.

http://www.clinicaltrials.gov/ct2/show/study/NCT01221597?term=peyronie%27s&rank=1&show_locs=Y#locn

Estimated Enrollment: 300
Study Start Date: September 2010
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)

2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.

Bummed,

You've got some opportunity now if you are in the acute phase.  Try to use the traction or VED devices... take pentoxifiline to inhibit TGFb1 (inflammatory agent present in Peyronies Disease - but rarely in normal anatomy).  Get cialis or viagra to get blood flow in there regularly...maintain the size.  I wish I had done MORE during the accute phase to avoid losing as much size as i did.  I thought the verapimil injections were going to be the way to cure this in the early acute phase, but i was totally wrong about that.  The other things have worked for me though...so try this stuff.  If you were in the xiaflex trial, you wouldn't be allowed to do any of it - by the way... no traction, pentox, etc... cuz they need to control the study.  So give this stuff a shot if you can.  It's gonna be a long time for xiaflex to hit the open market... you can do a lot of things in the meantime.  I haven't read any of your other posts so sorry if i am replying uninformed about your situation.

Wow March 2012 is disappointing.  I remember some on here saying that once it gets FDA approved doctors will start offering it, or even sooner, wonder what happened to those people?

Comebackid

Not to make it worse...but  that's just when the study is done... Then it gets in line at the FDA... then insurance companies have to catch up with payment (early dupuytren's patients using xiaflex were declined payment but auxillium is apparently working with the insurers who were not sure what to make out of a 3k injection vs surgery).  So, anyway I think people should do all they can in the meantime who are not in the study.  If I am getting the placebo - they supposedly will open it up to us first (the 100 of us who will have had 20 penile injections over a year period & 17 visits to the urologist, yay for us).  However, if the drug shows side effects or is not effective - or auxillium has financial problems or anything else happens - then that promise will be scrapped most likely.  We'll see.  The placebo guys will probably be treated in the march - may time frame (2012).

Mike,

Thats not extremely encouraging, thats a good bit of time to go still.  Do you see it being used on peyronies now that it is approved for DC?  This would be off label usage, I wonder if any top notch docs will try it or wait for the complete study from Auxilium, that might be a good question for your doctor.  Thanks for keeping us updated, its good to hear whats going on with this study!

Comebackid

In my opinion, most of top peyronies urology specialists in the U.S. are the one's participating in this study.  I counted 28 in 21 states, plus 5 in Australia.

Quote from: ComeBacKid on December 30, 2010, 05:02:38 PM
Mike,

Thats not extremely encouraging, thats a good bit of time to go still.  Do you see it being used on peyronies now that it is approved for DC?  This would be off label usage, I wonder if any top notch docs will try it or wait for the complete study from Auxilium, that might be a good question for your doctor.  Thanks for keeping us updated, its good to hear whats going on with this study!

Comebackid

I asked about this... they can't do it because of a few reasons... First, Auxillium won't sell the product to anyone except hand surgeons (orthopedic surgeons).  It's being extremely controlled bc they don't want people using it off label & then running into problems and killing the FDA approval process or the physician acceptance process (which in some ways is just as important as FDA approval).   Second, insurance will not reimburse this for off-label use.  It would be billed as a "procedure" - rather than something you pick up at the drugstore...so, though it's easy to get off label drugs reimbursed at the drug store (e.g. pentox is not FDA approved for Peyronies Disease) you can't get off label injections like this reimbursed -- especially since the shot is between 3-4k and I think you might need up to 8 of them.  Third, Auxillium has not made the details of the dilution process for Peyronies Disease public as far as I know.  Specifically, Xiaflex comes in a powder that has to be reconstituted in a very very specific way.  For DC, I suspect the dose is much higher to dissolve the cord.  In Peyronies Disease, it probably has to be lower given where they are putting it.   It's complicated as hell - and results are still unknown though they were positive in phase 2.  I'll post how it's going for me when I have something to report. 

Mike,

Hmm Sounds like they are really controlling this drug, probably worried about liabilities that someone didn't think of yet as well.  You asked sound questions, yes definately keep us updated!

Comebackid

There is a UK clinical trial for Xiaflex starting next month: http://www.peyronies-disease.co.uk/2011/01/xiaflex-trials-uk.html  I have no idea how many people they are looking for, or if they have already filled the places, but I thought this might be of interest to people here!! Thanks.

Since I just started as a participant in the third phase of the Peyronie's trial I did some layman's research on the mechanical side of Xiaflex and came across the following info on a Dupuytren's link:

"Xiaflex contains purified collagenase clostridium histolyticum, consisting of two microbial collagenases in a defined mass ratio, Collagenase AUX-I and Collagenase AUX-II, which are isolated and purified from the fermentation of Clostridium histolyticum bacteria. Collagenases are proteinases that hydrolyze collagen in its native triple helical conformation under physiological conditions, resulting in lysis of collagen deposits. Injection of Xiaflex into a Dupuytren's cord, which is comprised mostly of collagen, may result in enzymatic disruption of the cord"

It is fascinating to me that the drug - an enzyme made up of protein - is taken from a fermenting bacteria? Anyone know what happens when collagen is hydrolyzed? Evidently the matter changes form....maybe has a lot to do with all the following discoloration and swelling as well after an injection.

:) When I wikied it I even saw a refernce to gas gangrene....lol..I'm starting to think of the old axiom 'curiosity killed the cat' but can't help but be curious about the drug and what kind of reaction could possibly be going on in there if I receive the real thing. Oh well...back to the (drawing boards) search engines for more info! Hoping the cat has a few lives left!

BSSS

BTW,

If some of you kind gentlemen that are trained medically would tell me what happens to the collagen once treated/injected I'd be grateful.

I'd like to know what actually happens to the collagen, and how the body rids itself of what part of it is dissolved or whatever, if in fact it does.

Thanks!
BSSS

This question has been discussed widely, I thought the collagen is just dissolved?  However then, wouldn't that tissue need to be replaced?  Or perhaps it is just formatted into new flexible tissue.  Maybe Tim could weigh in on this or someone in the trials could ask their doctor this question and report back for us!

Comebackid

Quote from: ComeBacKid on March 03, 2011, 02:48:32 AM
This question has been discussed widely, I thought the collagen is just dissolved?  However then, wouldn't that tissue need to be replaced?  Or perhaps it is just formatted into new flexible tissue.  Maybe Tim could weigh in on this or someone in the trials could ask their doctor this question and report back for us!

Comebackid

I haven't even gotten a good answer to this.  I've asked - nobody seems to know.  In dupuytren's contracture, all you "need" is to dissolve the cord...and that's all that happens.  The enzyme is supposed to break the large, inflexible collagen structures down into tiny molecules that just get taken back in the bloodstream.  In Peyronies Disease, depending on the severity, once the plaques are dissolved, there needs to be rebuilding with normal / healthy collagen (my understanding is that some scars can be "released" in surgery - to reduce tension - but others require grafting due to the invasiveness into the tunica - so this varies).  Although some guys simply have the scar tissue sitting far enough "above" normal tunica (which i think is rare and unlikely - it's very intertwined) that dissolving the scar reduces the curve and improves everything...I think most are going to have a more complex situation.

I would not be surprised if xiaflex could lead to a worse hinge effect... if the scar tissue is causing the curve AND providing support - dissolving it could make the hinge worse if there is little normal tunica to support an erection.  I don't think we'll have good answers to any of this for years - many many guys have to try xiaflex in many situations (many of which are excluded from the study).  Nothing is out there to rebuild elastin or to encourage healthy collagen reformation.  Will the body do it on its own?  Maybe.  Who knows.  Will it work for everyone?  We've already heard from phase 2 people (not on placebo) that it won't... though there's not a lot of detail - just that it didn't reduce the curve.  This time, with 4 cycles instead of 3 - it might work a little better - and they measure the study subjects for 1 year after injection 1... so they are looking to see the body's response...at least in these "ideal" 200 cases that are going through it now.  So, the answer to this might be known in another 8 months or so.  

I don't have much faith the body will do anything to repair the area normally... given that it didn't repair the "microtrauma" right the first time.

I'm convinced it could alter the cells, I know with pentox my penis has become much more soft and flexible, doens't feel like a cast is on it when its flaccid, George is good at explaining the immune system and how pentox effects it and keeps it from attacking ones self.  If my penis can be made flexible again xiaflex could do the same thing.  This is pretty amazing stuff, and def. should keep people hopeful. 

I agree though no one has given a good explanation on exactly how xiaflex works and what happens to the bad tissue, does it dissolve, change into healthy tissue, or a little of both?

Comebackid

I asked an eminent urologist last week if he was optimistic about Xiaflex.

He said he is much more optimistic about (Xiaflex + traction).  Apparently Dupytrens patients use a splint.

Quote from: jw1441 on March 06, 2011, 09:20:53 AM
I asked an eminent urologist last week if he was optimistic about Xiaflex.

He said he is much more optimistic about (Xiaflex + traction).  Apparently Dupytrens patients use a splint.

i agree.  even in the study they have us doing "modeling" - which is nowhere as strong as traction and only for a few minutes.  traction would be better.  i just have not had any positive effects of traction, particularly on girth. 

Has anybody ever tried traction after xiaflex?  I think one of the dangers of xiaflex is that it can possibly give you a thinner tunica, so I don't know if you'd want to strap yourself in for 4 hours a day.  I think traction made a couple dents even larger, which sucks because i really felt like it was giving me back some stability and straightness.  I don't think I'll try it again unless I'm truly stable in Peyronies Disease.

Quote from: chefcasey on March 06, 2011, 05:20:03 PM
Has anybody ever tried traction after xiaflex? 

you are not allowed to for now

they just want to have you stretch it for a few min a day.

Chefcasey,

Your observation is wise, until someone can explain to me exactly what xiaflex is doing and what happens to the tissue, I would not combine xiaflex and traction, I would do xiaflex and give it a few weeks off.  People get to excited and want to swing for the fence with a full cure all at once, take it slow, and see what works, we got plenty of time, don't panic.

Comebackid

I don't know about traction while on the Xiaflex trial.  I am still sore and it has been three weeks since the shots.  When you do the modeling it makes it sore, I couldn't imagine having it pulled all the time.  No Thank You.

Has anybody in the xiaflex study noticed any improvement in their flaccid state.? Also I do not know if guys were excluded from the study because of hourglass or hinging .Have not read the criteria in sometime. If not excluded have you noticed any improvement with those issuses?


Fubar

Quote from: fubar on March 14, 2011, 02:32:35 PM
Has anybody in the xiaflex study noticed any improvement in their flaccid state.? Also I do not know if guys were excluded from the study because of hourglass or hinging .Have not read the criteria in sometime. If not excluded have you noticed any improvement with those issuses?


Fubar

Fubar,

Reference your hourglass question, here is the link to the study criteria.  Look at item 6 under Exclusion criteria. 

http://www.clinicaltrials.gov/ct2/show/study/NCT01221597?term=peyronie%27s&show_xprt=Y&show_locs=Y

Concerning improvement in the flaccid state, I finally noticed some and I'm almost at the end of Phase 3/beginning of Phase 4.  It's hard to describe but it seems to be denser/has more substance/more body.  I hope this helps. 

Humorous

Quote from: fubar on March 14, 2011, 02:32:35 PM
Has anybody in the xiaflex study noticed any improvement in their flaccid state.? Also I do not know if guys were excluded from the study because of hourglass or hinging .Have not read the criteria in sometime. If not excluded have you noticed any improvement with those issuses?


Fubar

not yet.....I've been through the first series of injections.  I also didn't notice much if any change erect.  I don't have a compass to measure angle, but at first glance it appears about the same.
I definitely do not have the hinge effect although I was concerned about modeling the first few days.

all you guys in the phase III trial might want to ask your clinic about the 'open label' follow up if you receive the placebo in phase III.  From the looks of it Auxillium is currently recruiting 250 subjects by invitation only to participate in the open label study and the one they are recruiting for now is only open to the phase II participants it appears. The open label part currently being recruited for ends 03-2012.  I have no idea if Auxillium intends to do anymore open label studies, but it might be worth asking about....esp if you think you are currently receiving the placebo.

Of course, I could be reading it all wrong, but the info I saw was on the govtrials website.

http://www.clinicaltrials.gov/ct2/show/NCT01243411?cond=%22Peyronie%27s+Disease%22&rank=4 (http://www.clinicaltrials.gov/ct2/show/NCT01243411?cond=%22Peyronie%27s+Disease%22&rank=4)

BSSS

Quote from: fubar on March 14, 2011, 02:32:35 PM
Has anybody in the xiaflex study noticed any improvement in their flaccid state.? Also I do not know if guys were excluded from the study because of hourglass or hinging .Have not read the criteria in sometime. If not excluded have you noticed any improvement with those issuses?

Fubar

Fubar,

I actually have some "official" results concerning improvement in the flaccid state.  At the end of Cycle 3 measurements (18 weeks), my length has increased by 2cm, which is about 13/16th inch.  (You can see my complete post in the Topic: Thread for Guys in Xiaflex Trial - Currently or Previously.

Humorous

good grief that is really a good new !! have you seen an improvement on erected state, or the gain is just in the flacid state ?

Humorous3

Yes I have read your other post ,awesome news! I wonder if they would continue injections after the study if you continue to improve.Or if they say that's it your done.Or the drug has run its course and would provide no more benefit.Man the question's go on forever.

Fubar

If your improvement reaches 15 deg. or less bend they stop your study.

Musicman

Thanks for your pm. I see your point many would be pleased at that point.If one having a 90 degree bend went to 15 yes I'm sure that person would be overwhelmed with joy ,I would also.The fact that they would cut me off after being their test Guinea pig would make me want to dot someones eye.

If I had a great improvement I would want them to go on treating me until it seemed it no longer had a positive effect.Putting your penis on the line for them so they can get wealthy? Should warrant ongoing treatment.

Fubar

Fubar,

Let's not forget that these trials are voluntary ... at the risk of sounding like I'm defending big, heartless biotech companies, people who have signed up know the risks and they know about the trial protoculs ... maybe there is good reason not to go beyond four treatment cycles -  the previous trial only went to three ...

Quote from: BSSS on March 21, 2011, 09:57:05 AM

Quote from: fubar on March 14, 2011, 02:32:35 PM
Has anybody in the xiaflex study noticed any improvement in their flaccid state.? Also I do not know if guys were excluded from the study because of hourglass or hinging .Have not read the criteria in sometime. If not excluded have you noticed any improvement with those issuses?


Fubar

not yet.....I've been through the first series of injections.  I also didn't notice much if any change erect.  I don't have a compass to measure angle, but at first glance it appears about the same.
I definitely do not have the hinge effect although I was concerned about modeling the first few days.

I do want to follow up this post with some notice of a change.  I've seen some difference in my angle when erect.  I didn't at first but the angle is less sharp, or more gradually curved.  I really couldn't put a number on it at this point and the info is anecdotal of course, but none the less encouraging. I did round one of injections several weeks ago and have been pretty good about remembering the modeling.

BSSS

is xiaflex intended as a treatment option for guys who present with no detectable scar via ultrasound , no curve per se, but rather inflammation and indurations?

Quote from: lespleen on April 22, 2011, 06:58:30 PM
is xiaflex intended as a treatment option for guys who present with no detectable scar via ultrasound , no curve per se, but rather inflammation and indurations?

There has to be a palpable plaque to inject it into.  It is not intended to be injected diffusely.

so it can't be injected where there's an induration and localized pain but no plaque?

Quote from: lespleen on May 01, 2011, 04:17:20 AM
so it can't be injected where there's an induration and localized pain but no plaque?

The substance is meant to eat through collagen based scar tissue... so i'm not sure you'd want it injected just anywhere... it could harm the tunica itself if it is just randomly injected.  Maybe in the future, guidelines for people with diffuse scarring will be developed but as of now, it's not for that purpose. 

So if it eats the plaque or scar tissue, what fills that void once that tissue is gone?  Does new tissue regenerate?  Otherwise you would lose mass and size.  The real question is what about someone who has scar tissue mixed in with healthy tissue, can the xiaflex differentiate and leave the healthy tissue alone or does it just eat up anything in its way.  If this is the case like Mike believes, then you would want to map out where the scar tissue and plaque is ahead of time with a doppler ultra sound and other tools and inject xiaflex in a targeted way.

Comebackid

Comeback, this sentence referring to Xiaflex is taken from the website of Mr. David Ralph, one of the UK's top Peyronies specialists ...

"The hope with peyronie's is that the tissue itself changes in composition and regains some of its former qualities (elastisity etc)."

http://www.peyronies-disease.co.uk/2009/09/xiaflex-for-peyronies-disease.html

So rather than "eating" plaque and leaving a void, he's suggesting Xiaflex might, and I guess we have to realise there's still plenty of uncertainty,  be capable of changing the composition of plaque, potentially breaking down the networks of collagen and fibrin and restoring the tissue to something closer to it's original state.

He does say however that the results of the xiaflex trials so far are "not exactly mind blowing".

The results are "not exactly mind blowing" were the words I believe of the website owner and not David Ralph.  However, I see your point that a 25% improvement depends on how bad you are to start.  Some of the guys I've been following seem to be getting 5 degree reductions with each cycle. That means 4 cycles and I would be fixed.  I can see it helping some guys very much. I was private messaging a guy recently who has had some pretty good results.  So much so that he is worried he may have improved so greatly that he can't carry on with the trial.

Worried Guy is right - this is not a quote from David Ralph but from the website owner ... the website owner is also referring to the previous sets of trials and not phase 3 which is happening at the moment (much larger with different amounts of cycles) as this was posted in 2009 ... this is old news! Incidentally David Ralph and his team are running the UK Phase 3 trials at the moment ...

Worried Guy/ronners, you've both concentrated on the last sentence of my post, which I added as an afterthought.  I agree it's out of date and not by David Ralph, so probably a bit misleading. Apologies for that. Great to hear positive stories coming from the trials btw Worried Guy.

My main point was to draw Comeback kid's attention to the statement which implies that xiaflex doesn't "eat" plaque and leave a void, but changes it's composition to something with hopefully more elastic properties. I don't know who's actually making this statement, but as it's on Mr. Ralph's Peyronies site I assume it comes with his approval.

Is this also out of date? What's the current consensus on how xiaflex acts on Peyronies plaque at the cellular level? Is collagen and fibrin actually broken down and re-absorbed by the body, or changed to something else? If so, what? I see some folks have had a go at speculating, but no-one seems quite sure.

Shrout, I agree it would be good to know for sure what actually happens to the tissue.  They must know as they would have tested it on tissue in a lab. 

Shrout, this is not David Ralph's website but the website of a member on here.  He occasionally gets emails from David Ralph's secretary but David does not instruct him what to put on here. His secretary was asking if he knew of any men who would want to participate on the trial.

The best way to understand the controversy is to follow Gelbard's work, in my opinion.  Also, remember there are several collagenase enymes in the body - and it is not entirely clear what Gelbard was studying vs. what Auxilium is running in trials - though they are obviously very similar.  

"Collagenase causes extensive  dissolution in vitro of  the  tissue  comprising   Peyronie's  plaques,  as  well  as  normal   tunica  albuginea.  There   are  factors which may ovvercome thi slack of selectivity and permit its clinical  us e  in the treatment  o f  Peyronies Disease." - Gelbard, 1982

Gelbard subsequently patented the use of  purified clostridial collagenase for Peyronies Disease in 1982.  His patent is very complex, but it appears he might find some selectivity by the collagenase enzyme (for the plaque vs. the tunica) under certain circumstances.  Here is how he describes treated plauque:

"Treated plaque showed widespread fraying and dispersal of collagen bundles compared to the dense compact collagen seen in untreated tissue....very little diffusion and spreading occur from the site of initial enzyme deposition....elastic tissue is preserved, which may be particularly important in treating Peyronies Disease..."

In 1985, Gelbard has some success, but has a setback with a patient with a corporeal rupture
http://www.ncbi.nlm.nih.gov/pubmed/2991611


Gelbard, 1993 reverses his opinion on the negative effects of collagenase from his clinical trial:
http://www.ncbi.nlm.nih.gov/pubmed/8417217


I don't know if Gelbard was using what Auxilium is using...two other patents have been filed since his patent.

In vitro, I think AUX collagenase was shown to dissolve the plaque of peyronie's in greater quantities than the tunica albuginea.  Why this would be is unknown and makes no theoretical sense.  I don't have the reference to the paper (or i might just not be remembering it right).  I know there is research where they took peyronie's plaques from surgical patients, cut them up, and then exposed them to xiaflex.  I THINK Xiaflex reacted more with the plaque - possibly because it had more collagen or that enzyme had a greater affinity for disorganized collagen which comprises the plaque.  It did not affect elastin.  In vivo, 0.58 mg is a very small dose, so the dissolved collagen should just be broken into smaller pieces that can be dislodged and absorbed by the body.  

Thanks for that reply, I see that, from what I've heard on here, the results don't sound exactly mind blowing, but the dosage level might be a little low, perhaps a different injection method or more of the xiaflex may work better.  Eventually this company will have to put up a product or go bankrupt, unless they are selling other things that do work.

Comebackid

I thought the same as you until I started to speak to people who are either on the current trial or have been in the past.  People seem to be making real progress.  Check out the UK Xiaflex page.  WFX has gone from 30 degrees down to 18 in just one cycle.  In the UK VED study it took guys months to achieve those gains yet 2 (admittedly painful injections and modelling) and the same can apparently be gained.  One of the guys on the study with a severe curvature improved by 25 degrees in one cycle. Another man from a previous cycle has improved "more than he could ever have imagined".  If Xiaflex does not work it will be at least a decade or two before we see anything else.  I'm growing more positive about it.  Many guys who have had it are not publically posting on here. No bad side effects have yet to be reported other than moderate swelling.  I don't think Pfizer will go bankrupt if it never went to market.  Some drugs are never passed it's just part of R&D.

Quote from: Worried Guy on May 26, 2011, 03:02:57 PM
I thought the same as you until I started to speak to people who are either on the current trial or have been in the past.  People seem to be making real progress.  Check out the UK Xiaflex page.  WFX has gone from 30 degrees down to 18 in just one cycle.  In the UK VED study it took guys months to achieve those gains yet 2 (admittedly painful injections and modelling) and the same can apparently be gained.  One of the guys on the study with a severe curvature improved by 25 degrees in one cycle. Another man from a previous cycle has improved "more than he could ever have imagined".  If Xiaflex does not work it will be at least a decade or two before we see anything else.  I'm growing more positive about it.  Many guys who have had it are not publically posting on here. No bad side effects have yet to be reported other than moderate swelling.  I don't think Pfizer will go bankrupt if it never went to market.  Some drugs are never passed it's just part of R&D.

That really is an impressive improvement. I guess the one question is, as the tissue heals will the improvement remain? If the answer is yes, then this is certainly an exciting and very quick improvement. With other treatments being utilised afterwards, that 18 degrees can probably be improved even more. With peyronie's there doesn't appear to be a ciure as such, but anything that results in imporvements like this is something that could potetnially be of benefut to many thousands of men! 

Quote from: newguy on May 26, 2011, 04:14:43 PMI guess the one question is, as the tissue heals will the improvement remain?

i asked a doctor this question.  he said it will only remain with traction in his opinion...with duputreyn's - they have to wear a special glove to keep the fingers extended.  In my opinion, you need traction AND pharmaceutical assistance.   if the penis is allowed to go back to it's flaccid, bunched up state - the scar has no reason not to form again.  keeping it stretched, regularly, while the scar is gone - WHILE inhibiting TGF b1 and increasing Nitric Oxide will make it harder for the scar to reform - maybe.  this is just theory...but I think this is the key.  a 1 pronged approach doesn't usually work in complex conditions.  And Peyronies Disease is more than complex...it's been an unsolved mystery for 250+ years.

also, they need to inject full plaques in multiple locations.  in the trial- they are just injecting a tiny amount in 1 tiny spot.  some people need more than this and in more locations.  xiaflex in multiple locations + traction + pentox + cialis will probably be the closest thing to a nonsurgical cure, if not better than surgery altogether.  who knows how long u will need to stay on pentox and cialis... but this is of course just my opinion on the matter.  I'd imagine the VED helping things too.

Just a question!  why would the scar reform?  The injection breaks down collagen bonds!  I agree it would be a good idea to stretch and model the penis after an injection but I don't see why it would reform.

Quote from: Worried Guy on May 27, 2011, 02:24:42 PM
Just a question!  why would the scar reform?  The injection breaks down collagen bonds!  I agree it would be a good idea to stretch and model the penis after an injection but I don't see why it would reform.

Long term follow-up with previous studies have shown that the reoccurrance rate is fairly low.  But I don't know if they are using traction or not.

Quote from: Worried Guy on May 27, 2011, 02:24:42 PM
why would the scar reform? 

Well, why did it form in the first place?  Some of us have a weird healing process...and who knows how our bodies will interpret this kind of collagenase "injury" ... maybe it is a non-issue to the body, or maybe it is something that will trigger more inflammation, TGFb1, etc... i dont think anyone knows enough about scar tissue to answer this.  Also, we might have  a chronic problem. The woman on youtube with duputreyn's had a cord form 1 year after xiaflex.  it's probably not the "same" cord (no way to know) but Peyronies Disease could be a chronic thing that keeps creating scar tissue, for some of us.  For others, it might be a more simple injury plaque that can be dissolved and that's the end of it.

Question, is using a VED a viable option to "traction"? Little off subject, but I was reading the regimens that some doctors are suggesting of meds and traction etc..

Quote from: pvpey on June 02, 2011, 02:07:08 PM
Question, is using a VED a viable option to "traction"? Little off subject, but I was reading the regimens that some doctors are suggesting of meds and traction etc..

VED doesn't seem quite so established with urologists for peyronie's disease treatment, but personally I'd certainly say that it's a viable option. It's popular here too, and there is good guidance from the likes of OldMan etc. I think the use of oral supplements, and a mechanical treatment (VED, traction) is the way to go. It seems that good progress can be made with both. If you find that one isn't for you, try the other. As long as you're doing something you're putting yourself in a good position.

Found this that was published the other day, the interesting piece which I suspect will also apply to Peyronie's is this bit and it does read positive

"In tissue explant cultures treated with XIAPEX, enzymatic digestion was most rapid in the first four hours following injection, with nearly complete lysis of collagen occurring within 12 hours. Collagen lysis in these in vitro experiments was confined to the area and volume of the injection, with sharp demarcation between the affected and adjacent unaffected areas. The result in these in vitro experiments appears to be selective lysis of the structural collagen components of the Dupuytren's cord with sparing of arteries, nerves and capillaries following local injection.(3)"

http://www.prnewswire.com/news-releases/biospecifics-announces-positive-xiapex-data-presented-at-xvi-annual-federation-of-european-societies-for-surgery-of-the-hand-congress-122930178.html

Does anyone know whether the Xiaflex (collagenase) treatments and subsequent "reshaping" have restored length as well as curvature in patients with Peyronies?

Has anyone had Xiaflex treatments with Dr. Irwin Goldstein in San Diego?

Quote from: acetyl on June 17, 2011, 02:00:05 PM
Does anyone know whether the Xiaflex (collagenase) treatments and subsequent "reshaping" have restored length as well as curvature in patients with Peyronies?

From what I know, that is one of the study outcomes, or at least I was told that.  Was also told I measured 2cm longer after a series of injections.

acetyl,
I have visited with Dr Goldstein, but not had any xiaflex injections.  He told me he was a test center for the drug.
I am curious as to what you think of Dr Goldstein.  He tried to talk me into something called penile revasculaization surgery for my ed.  He seemed a little too slick for me to trust him.
SSmithe

I've read article about penile revascularization. "They" take an arteria to link it with dorsal vein (which is called anamostose).
In the past it was called Virag V technique (named by R. Virag) but it seems that this technique is useless in cas of peyronie, and when it has some result they are not permanent.

Thanks for the replies RE: Xiaflex for regaining length and responses to inquiry about Dr. Irwin Goldstein.  I'll post my impression after my consultation with him.

Just had my first two shots on the first round in the open-label study and everything went swimmingly.  No change in curvature though.  It's been a week.  Will keep everyone posted.

I also just started the modeling procedure.  Three times a day certainly doesn't sound like much.  When I asked the urologist he said to just keep it to that but am tempted to do more modleing plus my FastSize extender along with it.  Is anyone doing anything extra like VED or Pentos besides what they tell you to do?  (Don't want to do my Pentox because don't want it showing up if they do blood work at the end of this.) Also, do you guys try to do the modeling in an erect or semi-erect state?

Thanks for the help!  :)

N.

Modeling into an erected state is a source of trauma. I think we need more time to know what modeling technique is the more efficient.
Personnaly my choice should be stretching with extenders : light to medium tension applied for several hours. Hard modeling on a erected penis sounds risky to me.

I just came across this and am very perplexed:

http://www.worthington-biochem.com/CLS/cat.html

How is collagenase available through this website?

I may be mistaken but I don't think auxilium has anything but a patent to use collagenase for peyronies, etc. Collagenase has had other uses over the years.

i dont get it, did they add more chemicals to the injection or something so its safe to inject in the penis? if they just put a patent on it why isnt it out for the public yet?

is it possible for plaque to compress or encase a nerve? and will xiaflex damage any nerves?

I had some questions reguarding Xiaflex. Iam hoping some of you guys that have been though the trails mite be able to ansewer.

1. If Xiaflex does work for you are the results permenant or will the plaques slowly reform requiring more treatments in the future?

2. If anyone has had pain or long term pain did the treatment help with the pain once the plagues reduced in size?

3. Did the plaque just reduce in size or did it disappear all together? Can you still feel the plaque that was treated? Do they still show up on the ultrasound?

4. If you had waisting at the plaque did it help reduce the waist or make it disappear all together?

5. Has anyone been treated that also had a Hypospadia " incomplete urethra from birth" that has been repaired by surgery in the past?


I really think this is where my future is going with Peyronies and trying to rap my head around it all. I am hoping it might finally be an ansewer and bring some relief.

Quote from: agent0 on July 25, 2011, 11:28:06 PM
is it possible for plaque to compress or encase a nerve? and will xiaflex damage any nerves?

It is possible for plaque to compress a nerve.  I've had pain now for over 5 years.  When I discussed this with Dr. Christine (Urology Centers of Alabama) in a phone conversation, he told me that was probably what was happening and that even surgery would probably not help and could possibly make it worse...Same opinion from Dr. Milam at Vanderbilt.  Dr. Christine did say, of course, that he can't make a real diagnosis by phone, but told me that my best bet may be to see a pain management doc...not very encouraging.  I'm scheduled for robotic prostatectomy on September 22 and I'm curious what effct this is going to have on my Peyronie's.  My surgeon says it probably won't make the pain any better or worse, and like every uro I've talked to, added it's "very unusual" for pain to persist for this length of time...lucky me!....Fred

Hello.
Do you thinks Xiaflex can be suitable also for a plaque caused by a Nesbit procedure and not necessarily by Peyronie disease?

yyy yes because both are made of excess collagen.

I just discovered that there is a doctor near my house that is working with Xiaflex. If I have calcified plaque, do you think this might work?

In the UK you are not allowed to participate if the plaque is calcified. It would be impossible to inject into bone.

Well, that sucks! Thank you. I think I am going to schedule a consult with Dr. Lue.

F~@< me! Glad I read this. Martin Gelbard is part of my Urology group and my primary Uro had suggested I contact him months ago as he is supposedly on the cutting edge of Peyronies research sponsoring several different trial treatments regularly. I've been an idiot for not contacting him sooner, but have not been taking this disease seriously enough.

Diagnosed about a year ago. I'm probably about 15-18 months into the symptom stages of the disease. Found this site while my primary Uro was suggesting VI injections about 6 months ago after 4 months of Verap ointment. My situation is posted elsewhere on this site, but in a nutshell here's my situation. Late 40s with 30-40 degree dorsal curve. Still have full sexual function including climax, but positions with partners are limited. On 10th month Verapamil 15%, no help with erection, but may have helped slow plaque hardening and decent flaccid appearance. However recent retraction into foreskin and possible upper level hardening is a big concern.

Met a great teacher on this site "Old Man" who suggested VED treatment. Went on daily 5% Cialis, continued use of Verapamil 15% topical along with VED use 3 times daily. Not a candidate for Pentox having A-Fib and taking Coumadin. Had to cease VED being Cardiologist felt could cause additional damage and bleeding at penile base due to Coumadin usage. Cialis usage also caused erections when simply walking in grocery stores. All bets off and became very discouraged. Leaving site because many stories seemed hopeless and depressing while hoping for the so-called miracle cures on the near horizon.

I'm back today and intend to contact Dr. Gelbard immediately. Due to other issues have been taking (stroke) chances and off Coumadin for almost a month now. Have heard Xiaflex causes very painful initial penile pain, severe bruising and inflammation, but if the end results are worth it, I'm in. Will see what other options available including this new enzyme therapy after consulting Dr. Gelbard and will report. May also go back to VED therapy for the time being as well. As per Doctor instructions I still need to have sexual relations and masturbate regularly (daily)

Being still pretty new and naive to this disease I have no idea what degree of calcification constitutes bone growth, but I do know that bones don't bend or are pliable. Although my affected areas seem hard, they are still more in the gristle state (for lack of a better description) than that of bone. Thus I think now is time to make a move forward.

pvpey:

You know what is best for your therapy based on your doctor's knowledge, etc. But, I firmly believe that VED therapy when used in a mild or moderate manner will not cause any further damage to you. So, if you do resume the VED therapy, just use a very mild erection state each pumping session. Less is much better in VED therapy than more, so try to observe that if you start up again. DO NOT OVERPUMP THE VACUUM AT ANY TIME!

Let me know if you have any questions about using the VED. Will be glad to assist in any way.

Old Man

Gelbard was the pioneer of collagenase (xiaflex)...since 1980, at least.  I think he holds the patents and AUX licenses it...not sure...or the patent expired...but he did the original work 30 years ago (yet still no treatment):

http://www.mendeley.com/research/collagenase-for-peyronies-disease-experimental-studies/

Please post here if you see him and let us know what he says... i assumed he retired by now since everyone just mentions levine, lue, and mulhall...but gelbard did a lot of the original collagenase work.

This newer patent  (http://www.google.com/patents/about?id=hOQDAAAAEBAJ&dq=6022539) seems hardly to advance Dr. Gelbard's method, which was also patented (http://www.google.com/patents/about?id=gTQ5AAAAEBAJ&dq=4338300).  Yet Dr. Gelbard is generous toward Xiaflex where he mentions it in his website http://www.peyronies.org/.  

Well I guess you might consider me one of those "newer patients", but after taking the time to visit Dr. Gelbard I finally see a light at the end of the tunnel in a positive direction. I only wish I would have sooner.

I'm not shy when it comes to explaining my condition, concerns and the discussion of alternative treatments in graphic detail with my physicians, but if you are, Dr. Gelbard will put you at ease immediately. This man is an expert and specializes in Peyronies.

As he'll tell you, this is rarely a disease, but scarring usually caused by trauma to the penis. And it's different in many cases, but alike in many as well.

We had long discussion in his office of my options, but the first was to determine if there had been any calcification in the large plaque area on the top of my penis causing a 30-40 degree dorsal upward curve. Luckily for me, x-rays showed negative thus I am still a candidate for all treatments available. If not, some sort of surgery would have been the most successful option. And the options he had illustrated before the x-ray were not very desirable to say the least.

He is a big supporter of Xiaflex although confirmed that the side effects can be like getting a low blow from Mike Tyson with a sore and black and blue member after treatment. But it shows the most promising permanent beneficial results in his opinion. Unfortunately for me all current trials were filled, thus I'm in limbo land until approved (maybe a few years yet). Or another trial becomes available.

For the time being I'm on a regimen to prevent further damage and any calcification I'd imagine taking Pentox and Colcrys (daily) with 5mg Cialis every other day. I return in 2 months (with pics of erect member sent prior) and we continue from there. I'll report.

I do not know what colcrys are but the rest sounds like a deal!

Fubar

Quote from: fubar on December 16, 2011, 11:29:23 PM
I do not know what colcrys are but the rest sounds like a deal!

Thats what I found:
Colcrys (colchicine) affects the way the body responds to uric acid crystals, which reduces swelling and pain.

Because colchicine was developed prior to federal regulations requiring FDA review of all marketed drug products, not all uses for colchicine have been approved by the FDA. As of 2009, Colcrys is the only brand of colchicine that has been approved by the FDA.

The Colcrys brand of colchicine is FDA-approved to treat gout in adults, and to treat a genetic condition called Familial Mediterranean Fever in adults and children who are at least 4 years old.

Here in europe docs are very jesitant to prescribe colchicine as it does have side effects..

Luc

so if xiaflex get rid of the scar tissue will the penis get smaller?

From reading the forum, especially the topics related to Xiaflex trial I think Xiaflex will make the penis longer and increase girth.
If you have a bend of 60 degree and dissolving or softening the scar tissues reduce it to 30 degree, simple geometry will prove that you gain length.
If the scar tissue is dissolved or softened, the blood flow will increase in the area and will make the penis more full, increasing girth.

I may be wrong, but reading the results people are posting, make me to think in this way.
Let's be positive and wait the final results.

One more think if you will be on Pentox, VED, etc' before Xiaflex, in my opinion it will help also.

James

Just a note,
while i was surfing I stumbled into a forum where Dr. Gelbhard was anwering questions of users.
Most question and answer wont really interest people here because the concern basics about Peyronies Disease.

But one drew my attention, here the question and answer:

QuoteAny progress found on the use of Xiaflex which is now in a clinical trial for use with Peyronies? It has been successfully used foe Depuyten's ( the curving of fingers).

Clinical trials are ongoing at this time.  A report on the first phase of testing will appear in the Journal of Urology in June of this year. MG

So the results of the trial will be published in June? or has it been postponed?
It looks as this post was from february this year..
Luc

I will quote bellow my finding regarding Xiaflex:

QuoteAuxilium Pharmaceuticals Inc. Partner : Pfizer (E.U.)

QuoteJames E. Fickenscher, CFO, commented on the data reads for the Peyronie's disease phase II program. He stated, "We are expecting top-line pivotal results of 2 phase III, double blind, placebo controlled trials in Peyronie's disease in late 2Q of this year."
Source: Cowen Group Health Care Conference, 3/6/12.

As for march 2012, the results will be published in June that is late 2Q.

The other thing I find is that all the "Peyronie's" forums/blogs that in reality are web sites sailing one or other miracle products to cure Peyronie's are talking very negative about Xiaflex. Why? It will ruin they business!!!

Myself, from the results of our forum members, I believe that even if it is not a "silver bullet" will help significantly at least people that don't have calcified plaques.

James

does anyone know where i can get news about xiaflex? besides http://www.auxilium.com ?

Any information on the web regarding Xiaflex (google & yahoo search) is based on Auxilium releases.
I didn't find any not Auxilium based information.

What is encouraging is that leading drug companies including Pfizer are running to make agreements with Auxilium for Xiaflex. It show they see BIG market with BIG profit in sight.

Attached Auxilium presentation to they shear holders with explanation regarding Peyronie's.

James

Xiaflex phase 2b results are on journal of urology website

According to headline under Auxilium at yahoo finance

is this the real xiaflex study by auxilium?
the one in the journal of urology is:

Phase 2b Study of the Clinical Efficacy and Safety of Collagenase Clostridium Histolyticum in Patients With Peyronie Disease
by Martin Gelbard, Larry I. Lipshultz, James Tursi, Ted Smith, Greg Kaufman, Laurence A. Levine

here is the fulltext:
http://www.jurology.com/article/S0022-5347%2812%2900114-0/fulltext

And there is a press release on the auxilum homepage, giving a summary of the study.
http://ir.auxilium.com/phoenix.zhtml?c=142125&p=irol-newsArticle&ID=1693677&highlight=


Luc

PS: stupid question... the whole study only had 146 patients? in 3 groups? thats less than 50 people treated with the real stuff world wide???
I thought the xiaflex study by auxilium was bigger..
Like several hundreds treated ... hmm strange..

Right about phase IIb study, just 147 patients in three groups including placebo, but in study phase III that the results will be late June this year are participating more than 800 patients in two groups including placebo.
http://ir.auxilium.com/phoenix.zhtml?c=142125&p=irol-newsArticle&ID=1693677&highlight= (http://ir.auxilium.com/phoenix.zhtml?c=142125&p=irol-newsArticle&ID=1693677&highlight=)

James

Quote from: james1947 on May 09, 2012, 06:02:03 PM
Right about phase IIb study, just 147 patients in three groups including placebo, but in study phase III that the results will be late June this year are participating more than 800 patients in two groups including placebo.
http://ir.auxilium.com/phoenix.zhtml?c=142125&p=irol-newsArticle&ID=1693677&highlight= (http://ir.auxilium.com/phoenix.zhtml?c=142125&p=irol-newsArticle&ID=1693677&highlight=)

James

Thanks for the info

I have had Peyronies for over 2 years now and thanks to this website and the information I gathered here, I am now pain free and have regained some of my lost size.

Quote from: peterjackson on June 30, 2012, 05:30:49 AM
I have had Peyronies for over 2 years now and thanks to this website and the information I gathered here, I am now pain free and have regained some of my lost size.

You've made several posts but haven't shared what your symptoms were and what you did to achieve improvement.

http://ir.auxilium.com/phoenix.zhtml?c=142125&p=irol-newsArticle&ID=1701869&highlight=

Interesting that even the placebo groups showed decreased curvature. Must be the result of injections disrupting the plaques

It is also my opinion as I have written before. It seems the needle effect punching the plaque and the stretching the following day (or two) is a part of the treatment effecting not less than the drug itself.

James

Anybody heard about this? 

The simple way to find some information regarding a subject is to make a search of the forum, the main page.
I get the links bellow:
https://www.peyroniesforum.net/index.php?action=search2
Xiaflex is the highlight 8)

James

It is well known and discussed here.  The trade name is Xiaflex.

I had my annual check up with Dr. Levine yesterday. All is great by the way since now 4 years post surgery.  :)We got into a discussion on Xiaflex and I thought I would share his comments here. I wasn't taking notes, other than mentally so will try to accurately restate his comments.

1. Levine has been presenting lectures on the phase three results. But he added that Auxilium has not released any actual statistics of the number of men who experienced positive results from the trials. I asked Levine what the parameters of a "positive result" would be. Levine said in his own studies, he only counted men that had a 10% or greater improvement. But he said Auxilium will count ANY improvement whatsoever. [My thought...... When the actual results are released they might be slightly over stated based on this approach]

2. Levine did say that even though the actual number of men who saw improvement has not been released, but that Auxilium is reporting some overall average statistics. Those that did show improvement ON AVERAGE had an improvement of around 20 degrees.

3. Levine stated that he knew of a patient that saw as much as a  60 degree improvement. [My thought.....  if a few people realized this much improvement, then many more would have a much smaller improvement in order for the whole control group to average 20 degrees overall (see point 2)]

4. Xiaflex is not going to be the magic cure. Based on the comments above there would be a small number of men who could see a significant improvement. While many others would experience a very small improvement.

Maybe some of this is not new to anyone, but wanted to pass this along.

Les

Well for a few of you that have read some of my posts, I'm still around. This disease is very traumatizing even after having the improvement that I had. Please read my post under improvement/ success. As to some thinking that needle and modeling making improvement in the Xiaflex placebo group, I don't think so. In the first trial I was in I received the placebo and received no improvement. In the trial that I received the real drug I felt the plaque snap as it broke apart. I can't feel much plaque, as before it was a big hard lump. In my opinion the Dr. administrating the drug makes a Big factor in the results. I think most of us are looking for a improvement with first a drug, a mechanical device, possibly some type of surgery, and the last being a implant. I know some will go with the implant, but for me it would not be what I would call natural. In time Xiaflex will be available. It will not have the same effect on all, but will bring some improvement for many.  Musicman

MUSICMAN

I had followed your posts from the beginning and I am happy you jumped in again.

QuoteIn my opinion the Dr. administrating the drug makes a Big factor in the results.

I agree with you 100% and I have expressed my opinion on that in the past.
From the other side I do believe that the improvements in the placebo group was do to the doctor capability to stretch the plaque in the correct way.
I also agree with your sentence:

QuoteIt will not have the same effect on all, but will bring some improvement for many.

Let's remember that Xiaflex is not a silver bullet, and don't forget that calcified plaques (like mine) were excluded from the trial.
Many of us have calcified plaques.

James

MALVERN, Pa.
Dec. 27, 2012
/PRNewswire via COMTEX/

Auxilium Pharmaceuticals, Inc. AUXL, a specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and granted standard review status to its supplemental Biologics License Application (sBLA) for XIAFLEX (collagenase clostridium histolyticum or CCH), a novel, in-office biologic therapy for the potential treatment of Peyronie's disease (Peyronies Disease). Under the Prescription Drug User Fee Act (PDUFA), the FDA is expected to take action on the application by September 6, 2013.

For the full press release:
U.S. Food and Drug Administration Accepts XIAFLEX� Supplemental Biologics License Application Filing for the Treatment of Peyronie's Disease - MarketWatch (http://www.marketwatch.com/story/us-food-and-drug-administration-accepts-xiaflex-supplemental-biologics-license-application-filing-for-the-treatment-of-peyronies-disease-2012-12-27)

Thanks for posting that. Thank God they're moving forward. I only hope that the FDA is not going to wait that late in the year to approve it. Pray to God.

Thanks for the posting BrooksBro.

MattFoley, I think they were moving faster if someone in the FDA had Peyronies.

James

James, no doubt about that.

When this company started clinical trials it excluded gay men! (as if they did not matter)!!! When I found a (New Haven, CT) urologist who participated in the trials, he asked me that would I be happy with just a 10% improvement! (my was at 53% curve down ward). He also told  so many negative things... I think he did not want me as a patient! Now I am being treated at Columbia Medical center in NYC. With Verapamil injections and with use of a pump 30 minutes a day and the andro extender( 2-4hours per night) for the last 90 days, I have had a 30%  improvement. The painful erections are gone! Dr. Peter Stahl is so professional and good at giving injections, I am so lucky to have found him. I travel from Connecticut to NYC  every 2-3 weeks! He thinks another 90 days of therapy will be needed and I will follow his suggestion. If you could see how much 30% is compared to what it was ...it is major!
I have one question that I read on a earlier forum, one man said the if you do not use the extender the curve comes back? was this with or with out the injection therapy?

DO

Welcome to the forum and thanks for the information.
Very few forum members had success with VI. I suppose that it goes down to the doctor capability (same is my opinion regarding Xiaflex).
I don't know about traction results, it is not available where I am living so I can't use it.

James

Quote from: DO on December 30, 2012, 02:58:14 PM
I have one question that I read on a earlier forum, one man said the if you do not use the extender the curve comes back? was this with or with out the injection therapy?

I used the extender for 4-5 months averaging 6 hours a day I recall. I saw improvement I could have lived with, however after stopping as it became not possible with my life, my improvement reversed considerably. This was without any injections. With benefit of hindsight I would have maintained some usage 2-3 times a week for about 1-2 hours. Hope this helps.

UK,

Have you had a full panel of blood work done telling you what your lipid and testosterone levels are? I urge you to do so if you haven't already. If you have, can you please tell me what they are? Thank you and God bless.

Quote from: MattFoley on January 02, 2013, 03:31:02 PM
UK,

Have you had a full panel of blood work done telling you what your lipid and testosterone levels are? I urge you to do so if you haven't already. If you have, can you please tell me what they are? Thank you and God bless.
Yes sex hormone binding is 65, :DHEA 68, LH 8.1, Total testostrone free and binding 540, free testoserone 52.4 Lipid level is 79, HDL 43, LDL is 72.

Quote from: DO on December 30, 2012, 02:58:14 PM
I have one question that I read on a earlier forum, one man said the if you do not use the extender the curve comes back? was this with or with out the injection therapy?

Generally Peyronies hits goes through an acute stage and then stabilizes. Once you correct or improve the curvature (or other impact) then it shouldn't return. There are a few men on the forum who have had more than one occurrence or attack of Peyronies. So I don't believe your original curve will return. But nothing says that Peyronies won't hit more than once. But that is a different issue than the original curve coming back.

DO, can you please tell me your age? I need to know your age in order to put those numbers in proper perspective. Feel free to PM me if you prefer. Thank you.

Quote from: MattFoley on January 02, 2013, 03:31:02 PM
UK,

Have you had a full panel of blood work done telling you what your lipid and testosterone levels are? I urge you to do so if you haven't already. If you have, can you please tell me what they are? Thank you and God bless.

I had Testosterone checked out in relation to Peyronies and it was good for my age, don't have the figures however as they are with my GP. I put mine down to injury and being unlucky as I am sure others have done worse and not developed this. There must be some susceptibility more prevalent in some people.

i got a bit of scar tissue. its bent only 20 degrees to the left caused by penile injections. my uro didnt detect significant scar tissue. but cautions that i stop injections. but its the only thing that gives me erect. i got 3 questions:

1 - will my penis be curved forever or will it go away?

2 - am i good candidate for xiaflex?

3 - does anyone know when xiaflex will be released?

Koolx

Quote1 - will my penis be curved forever or will it go away?

Very rarely will go away without treatment

Quote2 - am i good candidate for xiaflex?

Just your uro or a Peyronies specialist can answer to that.

Quote3 - does anyone know when xiaflex will be released?

Most recent updates
Xiaflex trials are over, maker files with FDA for approval for pyronies - Peyronies Society Forums (https://www.peyroniesforum.net/index.php/topic,2927.0.html)

James

koolx

since xiaflex is looking really positive and actually gets injected into the penis and right into the scar tissue is a bonus. Just try everything and when xiaflex comes out try that I would exhaust everything before you think about surgery. Its not really if your a candidate for anything its what your willing to do and try. Doing nothing will be that result nothing. Find a treatment that works for you a certain treatment that works for one person may not work for another it depends on alot of factors.

I think the study results are marginally positive, and they did not publish info about those with negative outcomes.   And you are assuming it is safer than surgery, which I think may be the case in the hands of the right doctor, after he has gained experience with enough patients.   Finally, I hope this is not the case however it is possible, similar to injectable steroid therapy, that surgery is not a viable option after xiaflex in some people due to undesirable changes to the tissue. 

I hate to say it but from a financial standpoint, the best case scenario for the manufacturer would be a drug that requires new injections every few years, and eliminates the option to have surgery after you are injected.   Unfortunately the lesson we can learn from the pharma industry is that treating symptoms is almost always more profitable than a cure because it creates lifelong customers. 

I hope things are more positive when the drug is released,  I just don't want to get my hopes up too high.

I am currently in the research for the drug Xiaflex. I finished my 4th cycle of 2 shots on Xiaflex directly into the affected tissue in the penis. I can tell you this it works but not a total cure.. I have lost over half the cure which is great. it looks good again..Hang in there guys there is help on the way

Did you participate in the original trials?

I am currently in current research study. " A phase 3, open label study of the safety and effectiveness of AA4500 (xiaflex) administered twice per treatment cycle for up to four treatment cycles (2X4) in men with peyronies disease". and there has been an improvement.

bigthumper

I was thinking the study has ended.
Can you give us some more detail regarding the treatment and the improvements?

James

I participated in a blind test study first, but the first time i received the placebo.
After the test was completed i was told that i could receive the real drug. The study consisted 4 injection cycles. Each cycle took 3 office visits in one week. the cycles were a month apart. a session consisted of, first session: an injection of Trimix ( in the penis) to get an erection and measurement of the cure the an injection to relieve the erection then you get the injection of xiaflex at the point of the curve, second 48 hours later was another injection of xiaflex in the area of the curve, third session was modeling which is bending the penis in the direction opposite the curve. the injection of xiaflex did hurt but was quick and not unbearable. The cycles were a month apart. I am finished with the 4 sessions now I have 2 more visits a month apart for measurement of the curve.
There is improvement, the curve has not totally disappeared but is far less. I do not know how much longer before the drug is released.

bigthumper

Any length and girth improvements?

Quote from: bigthumper on July 03, 2013, 09:36:19 AM
There is improvement, the curve has not totally disappeared but is far less. I do not know how much longer before the drug is released.

When you say "improvement", what degree change has there been?

I've read that the Trial consisted of 1 injection each month.
I'd like to know exactly what was the % of the drug injected.

does anyone know if xiaflex could somehow cause some degree of erectile dysfunction?

so xiaflex gets approved next month right? in September? i cant wait

My understanding is that the FDA will met September 6. At that time they will decide on Xiaflex.

Jackp
http://jackp-penileimplant.glogspot.com

so if they approve it. how long would it take for us to get the injections?

i need this. im so tired of being numb i need my life back.

agent0 I admire how you have been able to keep it together for over 5 years...I have been dealing with peyronies/sexual anhedonia for about half that time and I feel like I am going to crack any minute now. I would still not rush into Xiaflex just yet...best for them to work the kinks out first it is still a very new drug (for peyronies anyway)

I am going to send you a PM today please look out for it.

yeah, i feel like im gonna crack too. sometimes i get panic attacks thinking il be numb forever, but then i pray and just keep my mind off the subject by hobbies or talking to my gf. that really helps. it really helps for someone to listen and for that i am forever in debt to her. as soon as my uro can prescribe it to me. im taking the injection.

agent0, it's great that you have a girlfriend. I lost mine over this nightmare disease. I work non-stop to keep myself from losing my mind.

Copied quote removed by moderator

Wow these exact words could have came out of my mouth. Describes my situation exactly.

craig, do you have sensation problems? like numbness?

bigthumper, have you noticed an increased hardness in erections as well as decreased curve?

Is it possible for xialex to get rid of a venous leak if you get rid of the plaque?

Agent0

In my opinion don't have connection between the plaques and venous leak just if the plaque is located in the area that the veins should close to maintain an erection, but I am not a doctor.

James

AgentO

My wife and I are part of the Peyronies Awareness program being done by Xiaflex. We did a video in July telling our peyronies journey. It was not scripted and in our own words.  During that time I had a long talk with the Xiaflex rep.  A lot of information I have is confidential until after it is approved by the FDA.

The one thing I can tell you Xiaflex will not help venous leakage. 

Jackp
http://jackp-penileimplant.blogspot.com

Agent0,

Yes, James is correct, there is little to no correlation between Xiaflex treating the bend and the venous leakage problem. And as James stated, if the plaque is in the dorsal area then, yes, there may very well be some benefit to the venous leakage issue. Why? Because the plaque in the dorsal area is what is keeping the penis from being able to close off the vein tightly. If Xiaflex makes the plaque more pliable, then a chance exists. So, let's pray it does that.

Agent0,

You might want to give this doctor a visit:

Pain Relief for Neuropathy Pain, Joint Pain, Foot Drop, Pelvic Pain, Groin Pain (http://dellon.com/)

He is a neurosurgeon that can perform nerve decompression surgery on the dorsal penile nerve.  If your numbness is caused by a compressed dorsal nerve there may be hope yet.  I am thinking about seeing this doctor too if pentox and injections fail to help.

By the way guys, I spoke to Dr. Lue today and he told me that he's ready for Xiaflex. He knows where and how to do the injections so there will be no ramp up time for him. The only thing standing between me and Xiaflex is the insurance coverage. I'm praying that the insurance company will pay for it.

will do forester

My google alert on xiaflex led me to this-

Auxilium Pharmaceuticals, Inc. (AUXL): Auxilium: Serious Red Flags Make The Upcoming FDA Decision For Xiaflex A 'High Risk' - Seeking Alpha (http://seekingalpha.com/article/1871521-auxilium-serious-red-flags-make-the-upcoming-fda-decision-for-xiaflex-a-high-risk)

"Analysts at Brean Capital expect FDA rejection of Xiaflex in Peyronie's disease primarily due to their view that the Peyronie's PDQ generated borderline statistical significance and that there were many dropouts not included in the analysis."

We're four days away from a decision. Take this with a grain of salt, gentlemen. Analysts are paid to analyze. It doesn't mean they're right. However, even if approved we have to remember what may help some will not help all. Does that mean if Dr. Lue tells me it could help and we should give it a go I won't? No, I will. Because otherwise it's likely surgery for me.

I agree with you RoyHobbs but hope it will be approved. Even if it will help just let say 15% or 20% of the Peyronies sufferers, for them it will be 100% success ;D

James

When it comes down to it, if you search long enough you'll find an article that agrees with your position (or rather your level of hope):

3 Biopharmas Hoping for Good News From the FDA (http://www.fool.com/investing/general/2013/12/03/3-biopharmas-hoping-for-good-news-from-the-fda.aspx)

The general public has no idea the horror for a man to have to deal with this every day for the rest of their lives so getting Xiaflex approved and even getting a small benefit, like James said, is well worth the effort.

I whole heartedly agree, Matt.

I went for a physical yesterday to my regular doctor. This was the first time after peyronies. He asked if there was anything new and I told him about my peyronies. It was the first time he heard it. He was asking me all sorts of questions. So it is not only the general public.

Litani

That was one of the things brough out in our Peyronies Awareness video. Not only do urologist need to be educated on peyronies but the whole medical community.   

Jackp
http://jackp-penileimplant.blogspot.com

I don't understand how someone can be a urologist and know so very little about Peyronie's. Consider this forum: 80% of what I learned about from Peyronie's is from this website. I know more about Peyronie's than 90% of the urologists out there. What the heck, man? These so-called urologists should be ashamed.

so its dec 6th, does anyone have any info on if xiaflex got approved or not?

I believe it has been FDA approved for Peyronie's treatment!!!http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm377849.htm

Yes, it has!

I know Xiaflex isn't a slam-dunk cure, but this is HUGE, in a disease that has never had any HUGE news before insofar as treatments.  Pentox is probably as close as we've gotten. 

Hope springs eternal! 

Nemo

Quote from: searchmode on December 06, 2013, 01:15:32 PM
I believe it has been FDA approved for Peyronie's treatment!!!http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm377849.htm

Unbelievable ...!!! This is all about money. FDA is corrupt! I participated in the trial Phase 3. I got all 8 shots and that did nothing at all!

But if you believe in this - go for it. It´s all about the "placebo-effect". You can take what ever and the "placebo-effect will help your body to heal your decease.

Ok. We wont even try this, because it didn't help you. Thank you, we'll wait another 10, maybe 20 years for a new treatment and don't even bother with this.

I will repeat what I have said in an other place:
Even it will help 20% of the Peyronies sufferers it is OK with me.

James

http://www.washingtonpost.com/national/health-science/fda-approves-xiaflex-to-treat-peyronies-disease/2013/12/06/7b845096-5ea8-11e3-bc56-c6ca94801fac_story.html (http://www.washingtonpost.com/national/health-science/fda-approves-xiaflex-to-treat-peyronies-disease/2013/12/06/7b845096-5ea8-11e3-bc56-c6ca94801fac_story.html)

It didn't help a lot of people in the trial.  The average improvements numbers are pretty low compared to the placebo (34% improvement with xiaflex vs 18% improvement w/ placebo).  I am sure tons of patients will want this now - and they have no other option (verapamil doesn't work) - but there are still a few open questions: How well will it do under less controlled conditions (they excluded anyone with a hinge effect or narrowing, and no angles under 30 or over 90)?   Will insurance cover it?  If they insist on pricing it at $4000 a vial before doctor's fees... insurance might just make you have surgery.  My former insurance excluded xiaflex for duputreyn's completely (and it was a major insurance company).  The surgery was much cheaper.  Surgery for peyronie's has more side effects, though...so who knows.  Insurance usually cares about $ and not if your penis shrinks.

Another problem is that xiaflex cannot restore elastin or decrease generalized fibrosis or thickening.  Many people have these issues with their Peyronies Disease.  The plaque isn't the whole story, and that's probably why people had mixed results.  Some have felt the plaque dissolve over the years but the curve and narrowing never went away.

I still think this page has good info on the negative side of xiaflex, even though it's outdated as of today now that it is approved:  Auxilium Collagenase (Xiaflex) for Peyronies Disease - Clinical Trial Side Effects and Discussion (http://xiaflexpoison.blogspot.com/)

I'm not surprised it was approved because there's nothing else to treat this - and hopefully it will help some people - but they need to be more honest about who it is really going to help & why it won't help everyone.

Xiaflex was approved by the FDA today. 

I don't have a release yet to tell what I know but let me say this. It is not the cure all everyone is looking for.  I know several on this forum, and there doctors, that are ready to administer it that do not meet the guidelines.  It is still to be seen if it will be covered by insurance and Medicare.  This is one of the points I brought out in the Peyronies Awareness video my wife and I did in July.  Now that it is approved I am looking forward to getting a copy of the video. 

The biggest fear about Xiaflex several doctors have is it will be over used and used on patients that do not qualify and give it a bad name.  That will not help those that do qualify. 

If you go the Xiaflex route check out the doctor and his credentials. Most General Practice Urologist do not have the proper qualifications. 

Good Luck to all. For those that qualify it will be a great treatment.

Jackp
http://jackp-penileimplant.blogspot.com

You should be aware that Auxilium did exclude results that did not fit the bill. All participants in the trial that had none or limited effect of the injections were excluded in the final result (34%).

This is nothing but a big SCAM !!!

ThisWontWork

All participants in the trial that had none or limited effect of the injections would be the other 66%!!? or am I wrong??

Quote from: ThisWontWork on December 06, 2013, 07:47:00 PM
You should be aware that Auxilium did exclude results that did not fit the bill. All participants in the trial that had none or limited effect of the injections were excluded in the final result (34%).

This is nothing but a big SCAM !!!

What do you think of the results musicman had?

For how long this procedure has been talked about I would have thought there would have been more excitement for this approval. I really hope it helps a lot of people!!

I spoke with Dr. Lue about Xiaflex and he has a lot of confidence in it and he's ready to start treatment immediately.

ThisWontWork

Then don't take it!

Here's a good article about the recent Xiaflex approval:
Nonsurgical Peyronie's Option Gets FDA OK (http://www.medpagetoday.com/urology/urology/43283)

Very promising and includes opinions from a Dr. Gelbard who's been administering this since the 1980's.

Quote from: damian on December 06, 2013, 08:24:53 PM
All participants in the trial that had none or limited effect of the injections would be the other 66%!!? or am I wrong??

The way the results are presented is this:  The average improvement was 34% - overall... so with for everyone like musicman, there was 1 guy who had much more limited results, so the average improvement was 34% ... note that this isn't a 34% angle decrease, just a 34% change.  So, the average person went from 50 degrees to 33 degrees after 8 injections or 40 degrees to 26.  This is based on $32,000 of xiaflex (from current prices) + doctor visit fees...which makes me concerned about coverage from insurance.  Some people had amazing results like Musicman...lucky guy - if there's a such thing as "luck" in the Peyronies Disease world...that is definitely it!  Congrats musicman if you are still reading this.  Amazing recovery.

The trials differed...some had 30% xiaflex improvement vs 11% placebo:
http://ir.auxilium.com/phoenix.zhtml?c=142125&p=irol-newsArticle&ID=1693677&highlight

It's clear there are two camps on Xiaflex - the naysayers and the hopers (perhaps a third, as well: the haters). 

I think we have to view this in a larger sense - in the history of this horrible condition, this is the first time a government agency has reviewed data and approved a treatment for this condition.  We bemoan the fact that so few doctors, urologists or laypeople know anything about our affliction - that we suffer in anonymity in such small numbers that no pharmaceutical or research universities will throw any money at the problem. 

Well here is an example - the first! - of a pharmaceutical company throwing money at the problem, and the US Federal Government reviewing and approving it as a viable treatment.  I don't care what kind of axe you may have to grind with Xiaflex - that is a major step forward in finding a true cure for this condition. 

Maybe this isn't it, but we're a hell of a lot closer today than we were two days ago.  The approval of Xiaflex offers hope, even if you never intend on getting the treatment.

Nemo

I think it is very important to emphasize that the FDA Xiaflex approval is a CONDITIONAL APPROVAL.  It is ONLY approved for use by TOP PEYRONIE'S EXPERTS, not by just any general urologist.  What was learned during the trials was that the level of success was highly linked to the skill and training of the practitioner.  The importance of this cannot be overstated.  I am one of the last ones around here to have any confidence in the FDA, but in this regard they may well be on the right track.

For all the naysayers (and haters) out there, remember that this trial was designed to compare the effects of Xiaflex with placebo, and eliminate as much as possible other factors.  Therefore during the trial we were NOT allowed to use traction or Pentox, etc (we were allowed to use PDE-I's however).  My curve decreased from 30 to 18 degrees.  Would it have improved more if I could have used traction and Pentox? I would bet my medical license that it would have.  The doctors who will now be treating patients with Xiaflex will now be free to recommend those other treatments and will then learn if there may be a synergistic effect.

I don't know if the "naysayers" and "haters" comments are being directed at me (or "ThisWontWork") - but if I made comments on the drug that you don't agree with, please say what the comment is & why you disagree.  I have never had a true "fight" with anyone on this message board in 4 years - which I can't say for other internet forums.  We are all in this crappy  boat together here - and this forum has been a tremendous support. 

That being said, I have only been referring to the hard black and white data from the trials and what I have read from patients that is on here.  I am only speculating about insurance, as most people have been - even within Auxilium (see cafepharma).  I've been on this board for nearly 4 years, so I've heard many stories about the trial via private emails in particular - and I experienced Auxilium firsthand myself as I described in some old posts.  I started the trial thread myself two years ago, after all - so I've heard a lot privately.  So, these are the main (objective) issues with them that emerged over the years:

1.  There was a situation where a person went through the whole trial, put 1200 miles on his car, stayed in hotels for 10 nights, had 8 injections of placebo, had numerous blood tests, numerous penile exams and Caverject injections to measure in front of nurses and docs...for nothing.  When he moved to another state, Auxilium arbitrarily excluded him from getting the real drug (even though moving was never an issue in the informed consent).  He did miss a final visit out of 20 or so...at the end, and they had all the final measurements anyway.  If Auxilium "cared" about anything other than money, they would have mailed him the final questionnaire - and they would have given him the real drug for spending nearly a year in the study and getting his penis injected a dozen times.  But, they do not really care about people or spreading Peyronies Disease awareness...they care about money.  There was no way for this patient to even reach the company.  He spent months trying to contact them through their call center and through the study center - nobody would escalate his issue - he had to randomly type combinations of executives names @ auxilium.com to finally reach someone.  Nice, huh?  And the final result of this situation was that he got a letter clearly written by a lawyer- given its legalese - which is disgusting considering the time, money, and pain the person went through.  The letter quotes verbal statements he never made that "he never wanted the real drug anyway".  These were lies.  I am sure the PDF of this letter can be found and posted. His letter to the company is here:
Open Letter To Auxilium - Breach of Obligations to a Clinical Trial Patient - Peyronies Society Forums (https://www.peyroniesforum.net/index.php/topic,3282.msg45155.html#msg45155)

2.  Auxilium Collagenase (Xiaflex) for Peyronies Disease - Clinical Trial Side Effects and Discussion (http://xiaflexpoison.blogspot.com/)   
Two patients severely damaged by xiaflex in the trial - the top one received NO support from Auxilium (and is permanently scarred) and the other received support, but it took a full year for him to heal.  When the patient finally had de-gloving many years later (for grafting or nesbit - I can't remember), the tissue didn't heal properly on the left side because of what xiaflex did - even years later.  Also, his study doctor was horrible and should've been kicked out of running trials, but Auxilium needs its numbers and doesn't care if a study doctor causes complications like this.

So far, the product worked miracles for 1 person here: Musicman.  As of yet (per reading many comments on news articles after the approval) not much has changed.  Though I do not think internet comments are that telling of real world opinion, most reactions to the news story have just been rude jokes about bent penises.

George, yes I noticed a "training program" that they seem to want to fast track a number of doctors who can be "top peyronie's experts" - but maybe we are reading different things?  I am talking about what is here http://ir.auxilium.com/phoenix.zhtml?c=142125&p=irol-presentations  - on the Dec 6 presentation they allude to how they are going to train docs through the Auxilium Advantage program.  Two of the "experts" who were trained for the trial did this damage: Auxilium Collagenase (Xiaflex) for Peyronies Disease - Clinical Trial Side Effects and Discussion (http://xiaflexpoison.blogspot.com/)  - I know the name of the doctor and he has horrible online reviews.

Loyalty - you won't be able to use pentox if you get xiaflex because you'll risk increased bleeding.  You say you have a medical license, so you should know pentox has been associated with bleeding and/or prolonged prothrombin time.  www.sanofi.ca/products/en/trental.pdf‎    So far, we don't know the restrictions that are going to be put on prescribers anyway.  Many AUXL reps think that it will ONLY be allowed for the same patient group who was  in the trial (no hinge, calcification, hourglass, 30-60 degrees only, etc)  under the same conditions.  Why would you want to be on a drug that could increase bleeding when one major risk of xiaflex is bleeding / blood blisters?

I wouldn't wish Peyronies Disease on anyone except maybe my worst enemy - and this is not about the patients at all...it's about Auxilium's behavior.  If you want to talk about the drug, read the blog above - it is very interesting.  Xiaflex will not treat generalized fibrosis or tunical thickening beyond a plaque...the collagenase molecule is also enormous and so is collagen...so it doesn't break as easily as they want to have people think.   Anyway, it's great there's something new out there after 300 years - but the people behind it have done shady things to patients, and there is no denying that.  They are also extremely vague about who should get the drug (deliberately) in the PPT they delivered on Dec. 6.  Why can't they figure out who would be a candidate and who would not?  They had 4+ years!  So, now they just want to sell it to everyone and let it be open season to experiment on peyronie's patients while they get paid $3200 a vial to do it?  Totally irresponsible...but profitable!  Of course. 

This is a company run by shady people who pay themselves millions while delivering very little.  Pfizer dropped its association with them a long time ago...and nobody knows exactly why, but they know what they're doing.

The risk of increased bleeding with Pentox in someone treated with Xiaflex is a theoretical concern but in my opinion, the risk would be insignificant and far outweighed by the potential benefits.  There are studies in which fairly large doses of Pentox were given IV (much larger than the oral doses used for Peyronies when bioavailability is considered), prior to and continuing for 3 hrs after Coronary Artery Bypass surgery.  If Pentox can be studied in CABG, in which the chest is opened by splitting the sternum in half and leg vein segments are grafted onto coronary arteries, then it could certainly be studied in Xiaflex treatment where the injection is made with a tiny 30 gauge needle.

   Journal of Cardiothoracic Surgery | Full text | Effect of pentoxifylline on preventing acute kidney injury after cardiac surgery by measur ing ur inary neutrophil gelatinase - associated lipocalin (http://www.cardiothoracicsurgery.org/content/6/1/8)

"We performed a double blind randomized clinical trial, enrolling 28 consecutive patients undergoing elective coronary artery bypass graft (CABG) surgery. Patients were divided into two groups, one to receive Pentoxifylline 5 mg/kg intravenous bolus injection, followed by 1.5 mg/kg/h continuous intravenous infusion until 3 hours after cessation of CPB and the other group received placebo. UNGAL was measured before, 3 and 24 hours after surgery".

See also

Preoperative oral pentoxifylline for manage... [Heart Surg Forum. 2009] - PubMed - NCBI (http://www.ncbi.nlm.nih.gov/pubmed/19383582)

Quote from: loyalty on December 07, 2013, 03:03:04 PM
The risk of increased bleeding with Pentox in someone treated with Xiaflex is a theoretical concern

Well, that's good then...thanks for the article.  Honestly, I just was going off the PDR.  But, based on what you wrote - I agree there might be some synergies if taken together. 

The best approach will probably be traction, pentox, and xiaflex in the right area with the right dose - which is also something that seems to be a question mark right now.  They instruct docs to put it in the area of maximum curvature, but one dose for all plaques and all men is an odd way to dispense the drug because plaques come in different sizes.  And what if the tension is being held by thicker areas on the plaque vs. the area of maximum curve? Nobody really knows these things yet.  This isn't xiaflex hate...just my concern about how it will be administered for the best results.  I think it's going to be "field tested" in this regard...when it should have been tested by them before approval.

George999

As you may be aware my wife and I did a Peyronies Awareness video in July for Xiaflex.  I will tell you and all the guys raising a fuss that some of the problems with the trials were improperly screened doctors and patients.  Men received Xiaflex that did not qualify for it and that is part of the problem, and I fear will be for some time. Patients demanding it and doctors doing it to get them off there back, yes and also the money.   

I made it clear in the video and to the reps that general practice urologist should not be allowed to administer it. Proper screening of the patient is a must.  I know men her that are clamoring for it that do not meet the protocol.  If they find a doctor to administer it that could lead to trouble.

In a nut shell Xiaflex is not a silver bullet.  It is a first step in help men with preyronies.  With Xiaflex hopefully the awareness of peyronies will spur others to help develop drugs and treatments that will help us.

Just my 2 cents.

Jackp
http://jackp-penileimplant.blogspot.com

Thanks Jack for the excellent and balanced feedback.  I think you are hitting the problem right on the spot.  Hopefully the FDA will make sure only highly qualified docs get their hands on this treatment.  It seems to me like the kind of treatment, like hand surgery for example, that should be a virtual specialty in and of itself.  But their are a lot of docs, well intentioned or otherwise, that like to get their hands on things like this and in terms of the way they administer the treatments they are just real clods.  Its not new, we've seen it with other treatments as well.  This definitely should be a restricted drug.  Thats the way I read the FDA on it and I hope I got it right.

I think Nemo was the first to point out the most important takeaway from all of this: more people know about our affliction today than at anytime in its 300 year history. I would wager that there were more news articles written yesterday about peyronies than all other days combined. That's a win no matter what xiaflex does.

Some will see improvement. I bet most will not. Some will suffer averse side effects. Some will be totally fine. In a year or two we will know a heck of a lot more about this drug. In ten years we may learn of some horrific story about what can happen with this drug, or we might read about a miracle that came for someone who gave up all hope.

There are lots of drugs and lots of patients who have these types of stories. At least Peyronies is in the conversation. Maybe now there will be less knucklehead urologists getting in the way of making some man's life better.

-Roy

I will second RoyHobbs.
I also think that the most important thing with Xiaflex is the awareness to Peyronies.

James

I think that Xiaflex is just one more tool in the toolkit.  What remains to be seen, as several have already noted, is what some of the top Peyronie's docs in the country will be able to accomplish with it now that they have the chance to apply their skills and experience to it.  So I think it is really a bit to soon to evaluate the potential of Xiaflex simply based on the research data.  The fact that some have experienced major benefit from it is an indication that with the right technique it could hold a lot more promise than might be obvious from the current data.  There is also the possibility that clinical experience might create openings for treatment of at least some of those who would not currently be considered satisfactory candidates.  So now its available without strict research guidelines and I just can't wait to see what the really sharp and creative practitioners like Lue, Levine, etc. might be able to accomplish with it.  As has been very correctly noted before, Xiaflex is NOT a silver bullet, but it is a very promising new tool unlike any others previously available.  And that is pretty exciting to me.  So I remain very  :) about it.

Some experiences of Xiaflex have been very negative.
Did you read this blog?

Auxilium Collagenase (Xiaflex) for Peyronies Disease - Clinical Trial Side Effects and Discussion (http://xiaflexpoison.blogspot.it/)

I know my urologist is very positive about Xiaflex. He was part of the clinical trials  and treated eight patients (all of them doctors some traveling from as far a Texas to the Philadelphia area). Two of them were very successful and the other six were not. He said that the six who were not successful were calcified or partially calcified and he did not expect to see improvement for them. The two successful ones had pliable plaques and he thought they would be successful. He feels that I am a good candidate for Xiaflex. My next visit is in five months and I will very seriously consider using it. I am planning on letting him practice on others first.

My understanding is that the two or three patients that had penal fractures were caused by improper "modeling". After the patient is injected with the Xiaflex, the doctors stretch the penis to break up the plaque a day later. In the cases where the fractures occurred, the patient had an erection or close to an erection and the doctors tried to stretch the plaque against the curve and ended up fracturing the penises. The swelling and bruising doesn't scare me too much but a fracture does.

My original urologist was not part of the trials but he had a patient who was and he said the he had a 80-90% improvement.

I was reading the news about xiaflex now being approved, but only for 30 degree curves or worse.  My curve has improved to less than 30 degrees, but I can still feel the lumps in my shaft.  Also narrowing at the end of my penis and soft glans.  I was hoping I could be treated with this medicine.

IHatePD - That's interesting, but why did they have a partial erection?  The modeling was supposed to be done in a flaccid state in the trial. 

Restore - can you post a link to where you saw it restricted to those with 30 degrees or more?  This was speculated on CafePharma a while ago - and insiders at Auxilium were saying that it would be restricted to the same group as the study group (30 degrees / max 90, no hourglassing, no calcium) - but this was purely speculation.  I think it is a huge problem to limit it to 30 degrees because many of us started out with that and got worse.

I wonder if urologists are going to revise their "stable for a year" rule too - because again - that first year is when 90% of the damage was done.  In the study, you had to be stable for at least a year...so this might be another restriction. 

dioporcolorisolvo

This is the penis of one guy on these photos, I'm pretty sure. I can understand that he's frustrated for this kind of side effects, but he's somehow representing it like every second guy treated with xiaflex, will get the same sh*t. Life is risk.

Quote from: damian on December 09, 2013, 05:08:37 AM
This is the penis of one guy on these photos....he's somehow representing it like every second guy treated with xiaflex, will get the same sh*t. Life is risk.

There are two guys on the blog.  It says "Another Patient after collagenase injection in the clinical trial" between pic 2 and 3. The second guy had the hematoma under the shaft that took a year to resolve.  The top guy had blood blisters with permanent scarring on the top left of the shaft.

90% will get bruising, 50% swelling, 22.5% contusion  - see the statistics here:
The Safety and Effectiveness of AA4500 in Subjects With Peyronie's Disease - Study Results - ClinicalTrials.gov (http://clinicaltrials.gov/ct2/show/results/NCT00755222?term=peyronie%27s&rank=5&sect=X43015#othr)

For some reason they are only reporting 111 participants, when I think there were closer to 300...but there were several different divisions in their studies.  Not everyone is going to get that side effect, but some will.  Some people will get liver disease from tylenol, but not 22.5%.  To be clear - I am not anti-xiaflex.  I am just not a fan of their data presentation (e.g., lumping side effects like this as "edema" or "contusion" when they're far more serious, not reporting penile size change data even though it was collected & matters to a lot of people, etc) and how they are not clearly defining who will benefit most...they are just going to reap the profits of $3200 per vial while urologists experiment & write journal articles to say who got the most benefit & how.  Medicine is always evolving, but I don't think patients should be experimented on at their own cost with these kinds of side effects.  They should have determined why people did or did not benefit in the trial - and they should have determined what the best way to inject was (the point of maxim curvature is a guess - not an empirical choice).  They should not be giving 1 dose for all patients regardless of plaque size, but they never did a study to determine size-dependent dosing.  All of this would have cost them more time and money - and they did the bare minimum to get FDA approval so docs could do the remaining research for free.

If they put the criteria in the trials that high, it would never got approved. I think it has huge potential. It just needs enough experience.

My doctor in NYC just told me Xiaflex was approved! I did do the VI for 7 months! Yesterday was my six month follow up... He can not believe how well it worked for me! He told me it was not the norm! I give him credit because of his skill of injections, I listened to him with traction use and VED. I use many of the supplements recommended here. I am to  finish up the last of the Pentox in the next month or so. I will continue on the Cialis and some of the supplements. I do not have to see him again in a year!
I am so thankfull  many of the guys here who shared advise, and their stories. I helped me to stay focused and added to my healing!
The benefit was not perfect but I am very happy with the results.
wishing you all the power of healing and perserverence to get past the worse disease that any guy could have!
Dan

DO

Happy to read your post.
It will be very helpful if you will open a topic with detailed chronological peyronies symptoms and the use of medications, supplements,tracking and VED at:
Improvement - Accounts of improvements in deformity or erection. - PDS - Peyronies Society Forums (https://www.peyroniesforum.net/index.php/board,43.0.html)

James

I've got to check with Dr. Lue and see when he's doing the shots.

FDA approves first drug treatment for Peyronie's disease (http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm377849.htm)

so i went to check with my uro and he said that he'l get xiaflex around January to march, and he said he'l call me once they get it.

my problem is with my nerves. iv been numb for a while now and he said that the scar tissue could possibly be affecting my nerves, which is causing my penis to become numb.

i don't have a bend. i have a dent though.

he also said that xiaflex might have alot of risk to it, like infection. my question is to the people who were in the trial, could you lose any size from xiaflex?

could xiaflex cause more scar tissue from injecting it into your penis? could xiaflex decrease erection quality?

also im quitting cigarettes through smoking e-cigarettes does anyone know if they are actually harmful?

i was thinking to myself maybe my penile tissue is so damaged down there which is causing me to be sooo numb, or maybe its the scar tissue conflicting with my nerves another words, maybe

its putting pressure on the nerves is causing me to go numb. in the end, i don't know. my MRI 's and my Doppler came back fine. my uro said i do have scar tissue and he said it was little but it

was really deep. he said that could be causing the numbness. the most scariest thought of all is if im gonna be numb forever. i don't know what will happen to me in the future, but if im numb

im pretty sure its gonna be grimm. so know my plan is to wait for my uro to call me for the injection and pray to god xiaflex brings my nerves back. also i know my back is fine because i took an

MRI for that also.

"also im quitting cigarettes through smoking e-cigarettes does anyone know if they are actually harmful?"


That's how I got Peyronie's. Smoking is horrifically bad for the penis. If I hadn't taken up smoking at the age of 46, I would never know what Peyronie's is. You need to stop and never look back. E-cigarettes are not harmful to the penis. It's the tar that does the damage.

yeah im definitely quitting. its just the stress of being numb that really gets to me. im switching over to ecigs since its a healthier alternative.

I took Chantix to quit smoking. It's an amazing drug that has few side effects and it makes you hate smoking. I highly recommend it. Xiaflex will be a much more effective drug if you're not smoking.

There is no correlation between peyronie and smoking.

I wish you were right. But sadly and tragically, you're incorrect. Dr. Lue verified that smoking could very well cause Peyronie's.

Also, http://www.ncbi.nlm.nih.gov/pubmed/11752860 (http://www.ncbi.nlm.nih.gov/pubmed/11752860)

In my opinion is correlation between almost everything and smoking and in my opinion mainly because of the reduced oxygen supply while smoking.
Also many researches had been done on other damages that smoking is doing, including ED.

James

The really screwed part of this is that I only smoked for a few months before the Peyronie's struck. Total stupidity.

Guys I think we have a tendency to look for a cause and ascribe our Peyronies Disease to something distinct like smoking or Propecia or beta blockers, or a high glycemic diet, or whatever ... it's human nature and gives us some tiny degree of sanity to think we know a cause at least.  In truth, I think we're often times just connecting dots that may not be connected or only partially connected. I think the truth is we're genetically predisposed (or at risk) of developing Peyronies Disease - the gene wheel was spun at our birth and we lost.  There are guys out there who have sex accidents and never get Peyronies Disease - same with smoking, inflammatory diet, no exercise, etc., etc. ... they don't get Peyronies Disease.  We do, because it's a defect in our genetic code.

I think we just have to accept that for many of us, there is no smoking gun - there's only now "do the best we can with the hand we've been dealt."

Best,
Nemo

I could not disagree with you more Nemo but I still got much respect for you.  Have you looked into epi genetics at all? Check out the study I posted about meditation causing a decrease in gene expression related to inflammation. My hypothesis is that there was an underlying psychological stress be it aging, etc that possible on relation to sex trauma caused peyronies. However this has not been tested.

My point being looking at our genes in such a deterministic view is not only scientifically incorrect as we are learning but also places is as helpless victim

Cheers

I definitely agree that genetics may be the main factor, I know for sure my father had it :(
I even can say for sure that traumas to my penis didn't developed to Peyronies, except the last one some five years ago :(
From the other side, is good to eliminate any risk that may "wake-up"  this genetic factor :)

James

James, I learned my Dad developed Peyronie's too, in his 70s!  No pain, just woke up one night with a bend. And BOTH my parents had a mild case of Dupuytren's in their hands.  How's that for drowning in the gene pool! 

Nemo

we share 60% of our genes with a banana, 90% with a mouse, and more than 99% with a chimpanzee.  This is fact.

....

Reinventing The Body, Resurrecting The Soul is based on breakthrough ideas that have recently come to us from the worlds of biology and physics.
We know - and have known all along - that our body is not a structure. Rather, it is a process. When we experience the body as a process, we recognize that it never stands still.
The fact is that the body we have right now is not the body we had one year ago.
Our stomach recycles every 5 days.
Our skeleton recycles every 3 months.
Even the DNA which stores memories of millions of years of evolutionary time - the actual raw material of our DNA changes every 6 weeks.
So, you do in fact reinvent your body once a year.
But, you reinvent it the same way over and over again. It retains the same patterns; it has the same illnesses; it has the same problems.
Reinventing the body is based on 5 breakthrough ideas:
1. Your physical body is a fiction. 2. Your real body is energy.
3. Awareness has magic.
4. You can improve your genes. 5. Time isn't your enemy.

Guys this threat is getting WAY off track (I'm guilty too).  Let's try to keep it strictly about Xiaflex for the benefit of guys searching for the latest on Xiaflex. 

Nemo

Quotewe share 60% of our genes with a banana,

Well that explains why my dick looks like one.  :P

My doctor tells me Xiaflex will not be available to him for treatment of Peyronie's for another two months. What do you guys hear?

Nemo is right, we got really out of the topic.
Please stop posting anything not connected to Xiaflex and Treatment results (including me)

James

I spoke to Dr. Lue's office and his nurse told me that Lue would be most likely ready to perform the injections by around March 1st, 2014. The nurse also said that they are making sure they are ready to handle the insurance companies as well so we can get coverage for the Xiaflex treatment.

It will be good news for many if the insurance will pay for Xiaflex.
Thanks for the info Matt.

James

You're welcome, James. :)

I think the urologists who are going to be administering Xiaflex are already gearing up to deal with the insurance companies who are going to naturally balk at the cost. But since the FDA has approved this as the only non-surgical treatment solution for Peyronie's, the insurance companies are ultimately going to have to give in.


Here's some good info that "PeyroniesMan" provided:

"After making contact with Health Well Foundation, Auxilium's representatives and patients already in process. I have more information on Xiaflex and the coverage, and possible reduction in costs to you, the patient. This is the old good news/bad news thing. (Like we aren't already used to that!) So here is what has been told and what I have garnered through my discussions. From my perspective it is understood by Auxilium that the cost of Xiaflex will be out of range for some of us, but at least they are endeavoring to make that cost slightly tolerable. I, for one, sit in that "out of range" class. Hope this helps you guys!

Auxilium Advantage is a patient support program for patients and providers at 800-743-2382, 8:00 am-8:00 pm, EST. Currently, there are some payers that will cover Xiaflex for Peyronie's Disease without any hoops to jump though (Medicare, Tricare, Kaiser, VA). There will be some commercial payers that will cover Xiaflex for Peyronie's Disease, but will be requiring a prior authorization right out of the gate (i.e. Aetna, Coventry, United Health Care) The majority of the commercial payers will not recognize Xiaflex for Peyronie's Disease on their Medical Policy for a minimum of 6 months (this is common practice with many insurance payers with ANY newly approved FDA drug). However, just because a payer will not recognize it on their medical policy, doesn't mean there are not ways to get the drug approved (i.e. Prior Authorization (PA), Letter of Medical Necessity (LMN), Appeal Letters, etc). What the Health Well Foundation wil do as Senior Reimbursement Counselors is provide patient support services for the Health Care Provider's office and most importantly the patient. Equally important, when an appeal is denied, they will get the Key Account Directors involved to speak to medical directors of the insurance payers who denied it to try to get them to approve it.

Important Safety Information (ISI) for Xiaflex for Peyronie's Disease is now available at www.xiaflex.com (http://www.xiaflex.com).

Auxilium Advantage Xiaflex copay program: will assist qualified patients with up to $1000 for their out-of-pocket costs for each vial of Xiaflex. This program is available for commercially insured and uninsured patients. Cannot have Medicare, Medicaid, VA , or Tricare (or any state or federally funded insurance). www.xiaflex.com (http://www.xiaflex.com).

Auxilium Advantage Patient Assistance Program (PAP): offers Xiaflex to eligible patients without health insurance benefits who meet specific program criteria including income requirements. Patient's income must lower or at 250% Federal Poverty Level to qualify. Patient must submit one of the following 1040-EZ, 1040, 4506-T Request for Transcript of Tax Return, SS Letter, or Notarized letter for income verification. PAP Application form will be filled out by HCP and patient and must be sent to Auxilium Advantage by the provider. Once the patient is approved, Xiaflex is free (no cost to the patient). www.xiaflex.com (http://www.xiaflex.com).

Alternate Resource-Not part of Auxilium Advantage- "The Healthwell Foundation":
800-675-8416 - Open 9:00am-5:00pm (EST) www.healthwellfoundation.org (http://www.healthwellfoundation.org)
Must have form of insurance that covers medication (Medicare, Medicaid or Commercial)

Patient's insurance must cover the mediation for at least $25.00. Cannot have a HSA, HRA or Discount Plan. Patients income must be up to 400% Federal Poverty Level to qualify. If patients qualify, they are given $5,600.00 per calendar year

www.xiaflexrems.com (http://www.xiaflexrems.com) is the website that Health Care Providers will need to access in order to be REMS certified to administer Xiaflex as well as have their Health Care Setting REMS certified as a "ship to location" to receive the medication. These are FDA Requirements."

Quote from: Humorous3 on January 01, 2012, 01:51:49 AM
I did have a 4.5-5.0 cm increase in length.  As the curve decreased, the length increased, which I think was a natural process.

I think I missed this before - but since Xiaflex is in the spotlight, I wanted to clarify: You had a TWO INCH gain in size (5 cm).  That's quite amazing...but how long is your penis?  This is an extremely huge size gain for an average sized man (5-6 inches).  This is obviously an anonymous forum, so I don't mind asking (if we were in person, I would not be asking most likely!)  But I think this is an important thing to know.
 
You said the trial doctors did not measure girth and you did not measure it - but visibly, was there a change?

How have things been since the trial ended?  A woman in the dupuytren's study posted a video of her possible recurrence after the trial ended...I assume you are recurrence free?    https://www.youtube.com/watch?v=p787uTsNdAs (and she has many more vids)

With such a massive size gain like you had, why do you think Auxilium neglecting to report average penile size changes?  These were data points, after all, and this is a huge concern to men with Peyronies Disease.  Did you hear of other patients gaining anything like this?

Humorous3 was last active at April 02, 2013, 02:33:07 PM.
Hope he is visiting the forum as guest and will login to answer MikeSmith0 questions.
I don't know how I miss the fact you are mentioning MikeSmith0. Gain back of 5 cm it's huge, it will give back my original lenth before Peyronies :)

James

My doctor was in the trials, and I told him about this post.  He said there is almost no way he gained back 2" - it's virtually impossible.  Dissolving the plaque does not restore length like that...Peyronie's is not just a disease where you get a plaque - you also get tunical thickening and destruction of tissue aside from just having a plaque.  Xiaflex does not cure these things or restore elastin.  And, how big of a penis do you have that you lost 2"?? 8"? 

Also, my doc has operated on many guys who he gave the real drug to and who had no response or insufficient response.  It's interesting how "humorous" had such a perfect time in the trial and had such amazing results...don't you think?  He also quoted the trial protocol's with such perfection - almost as if he worked there.

Here are some REAL pics:  Auxilium Collagenase (Xiaflex) for Peyronies Disease - Clinical Trial Side Effects and Discussion (http://xiaflexpoison.blogspot.com/)   

Maybe he should post his "2 inch gain" ... especially since Auxilium completely neglected to report any size change data...despite measuring it in EVERY visit. 

I have a bend/twist to the left of about 30 degrees or a little less the left. When I measure, the right side (opposite of the bend) measures longer than the bended side. Is it possible that if the Xiaflex treatments are a success that my size would be closer to the measurement of my right side?

If the plaque is causing the bend and if the doctor hits the right spot and if the plaque responds to the Xiaflex, then yes, there is a possibility it will fix the situation to some degree.

does anyone know are there any feedback about xiaflex for hourglass or narrowing cases?
all feedbacks is related how the curvature got better.

MeMo

You may want to read the posts of the people that participated in the trial:
Thread for Guys in Xiaflex Trial - Currently or Previously - Peyronies Society Forums (https://www.peyroniesforum.net/index.php/topic,1458.0.html)
&
UK Xiaflex Trials - Peyronies Society Forums (https://www.peyroniesforum.net/index.php/topic,1558.0.html)

James

I had an appt with Dr. Gelbard today in Burbank, who had more xiaflex patients in his trial group than anyone else in the country. I'll write up a recap of that appt when I have more time, but he pointed to me not having any hourglassing as a positive when assessing whether I would be a good candidate for xiaflex.

hi all, last week i meet a uro in germany. he was involved in the xiaflex studies.  I ask him is xiaflex a option for me. Then he sais no. Xiaflex is only  for the early stage. But he  was definitely not convinced from xiaflex.  Complications with some  patients. Today  i can say: For me xiaflex is not the way.

I'm considering Xiaflex treatment. Have had Peyronies Disease for over 4 years with stable curvature of about 70 degrees.  Also had almost 2 inch loss of length and some girth.

Is there a diagnostic protocol that includes imaging before administering Xiaflex?  Also, I have heard that Xiaflex is not effective on curvature due to calcified plaque.  Is that true?  If so, can the calcification of the plaque be viewed through ultrasound or other diagnostic imaging?

Thanks!

I know that certain doctors use a color Doppler ultrasound for imaging to determine plaque location and to check for blood flow and any other issues that might be present. the ultrasound is done from many directions so that images can be taken to look around the scarring if necessary. Calcification does show up as 'speckling' on the image with the density varying to the degree of calcification present. I'm guessing that Xiaflex like Verapamil becomes much less effective on calcified plaque. But I'm sure depends on the extent of the calcification.

I actually have had a few shots of Verapamil and I can tell you that it has worked for me.
Tremendous change and progress - First off the best doctor I can ask for.
Before this I was so miserable, down and felt useless

GusVG

Can you give us some more details regarding your Peyronies and the improvements following the VI?
Please give us also the details of the doctor, other members may benefit from his knowledge also.

James

First off, I may be the exception to the rule, but I can tell you that I had no girth, curvature was extreme and lost over a year - initial doctor was the biggest DUD. I never really had that much pain, nor did I ever had an issue with having erections, even to this date. The plaque I had and/or felt was on the left side and pretty much on the entire length. Some heavier than others. My new urologist made me feel very comfortable and gave me hope. Gave me 4 shots of verapamil one every 2 weeks or so, and after the second or 3rd I saw results. I had another shot today in an area smaller than previous - again if not for this doctor I am not how I would of made it through. It sucks! I'll let you all know once done, have 2 more shots to go, 1 every 2 weeks

I'll ask the doctor next visit if OK to mention his name. Sorry, but I have to make sure it's ok with him, I owe him that and more...

I just read about Xiaflex for the first time today.  First drug cleared by the FDA for treatment of Peyronies.  But, $28,000 for a full treatment regimen?  Geez, it better be a miracle drug for that price tag.

Has anyone actually gotten their insurance company to pay the $3,000/shot price of this stuff?

Accessteam-

There are multiple threads on xiaflex in this forum. You will find the answer to you question in the other threads. Insurance appears to be covering a large chunk of the cost for some members.

$28,000.00 for Xiaflex injections... - Peyronies Society Forums (https://www.peyroniesforum.net/index.php/topic,4714.0.html)
Insurance coverage for Xiaflex - Peyronies Society Forums (https://www.peyroniesforum.net/index.php/topic,2912.0.html)
& others

James

Hello, all.  I was diagnosed with Peyronies in January of 2013.  No hourglassing, 45 degree bend, early stages and stablized quickly.  Went thru verapimil injections twice with little benefit.  Tried a traction device with little benefit.  I waited for xiaflex approval for months and was on the phone with my urologist the same day that the FDA approved in last Dec.  I naively though that I would then just make an appointment and go in for a xiaflex shot.  But, no......not even close--though approved by the FDA, my uro could not get the drug delivered to him.  No reason given.  After a few more months of appointments and phone calls to the manufacturer to learn what the availability would be, I learned a few things:  my urologist will not be allowed to have the drug any time soon (lots of reasons).  In my state (Wisconsin) I could only find ONE urologist that was allowed to have the drug and do the injections.  There is some company reasoning behind this slow roll out that I can explain to anyone who wants to write to me.  It seems to be either a big secret or just poorly communicated so it seems like a secret.

Sooooo  I find and meet with the one doc in my state who has access to xiaflex, and I learn he has treated a total of ONE prior patients.  He has had the xiaflex training, however.  A month of questions and emails with his nurse regarding ins preapproval and.....my insurance denied coverage because I did not express that I was having pain or that it interfered with intercourse.  I IMMEDIATELy told the nurse that, in fact, I had pain and it interfered with intercourse (yes, I would have said anything at that point).  Thirty minutes later my ins company approved the treatment!!!  And I then received a confirming letter!!  Now I am waiting for another month so far to actually get the drug delivered to my doc, which is turning into another mystery hurdle.  Then I go in for the first shot.  It could be next week or next month or ?.  I will report here on how it goes.  I am hopeful.

biocob-

The FDA approval was a conditional approval meaning only certain urologists with approved training would be allowed to administer the injections. I think this is a good thing as a number of us here have been to urologists who knew less about the disease than us. But happy to hear you're on your way. I'm still waiting for approval, though my delay has been caused by a number of patients waiting in line and only one rep in Southern California dealing with all the paperwork.

biocob

Did you ever tried oral medications for Peyronies?
It seems strange you got Verapamil injections (twice) and no any oral med.
Anyhow, wish you successful Xiaflex treatment and soon.
Don't forget to update us how are the results.

James

Does Xiaflex help guys regain lost length from Peyronies? 

xiaflex treatment update. 

Finally had my first two injections of xiaflex this week!  Monday morning and yesterday morning.  Lots of swelling and purple/red bruising and stabbing pain.  All fading by today.  Monday I go in for "modeling".  I am cautiously optimistic that I will see some improvement.  I will keep you all updated.  I will say this:  my doc and his office did a great job.  Calm and knowledgeable and right on top of things.  It pays to shop around for the best doc possible. 

By the way.......that little needle and the quick shot of xiaflex hurt a heck of a lot more than a 15 minute session with the verapimil shots (and the big needle).  Then random, spontaneous stabbing pain in my guy the rest of the afternoon.  The last episode was when I was standing at the walmart pharmacy counter, waiting for a pain pill prescription to be filled.  That sucked.  They almost called 911 as I was doubled over for two minutes.

James, I was prescribed pentox and took it for six months orally.  But that was only because I asked for it.  i was warned it probably would not work, and it didn't.  I also took: L-carnitine, L-arginine, vitamin e, ubiquinol, and low dose cyalis.  I don't think any of that did anything to improve my condition, but I was desperate, and so I tried everything i read about as I waited for xiaflex to be available. The one thing I tried that seemed to work a little was a traction device (I used the andropeyronie device from Spain).  I actually saw some small improvement.  I plan on trying it again for a few hours per day once i get past the first 30 days after xiaflex. 

Quote deleted by moderator. Please read the forum rules!!!

biocob i sense your lying every peyronies disease specialist or competent doctor that knows about peyronies disease will give you pentox as a first line of defence. All the medications you describe i highly dont think they didnt work some.

What helped me to soften my plaques, three hourglasses disappearance, gain 1.5 cm from lost length and some girth is:
VED, Pentox, low dose Cialis, Ubiquinol.

James

Hi, I'm just joined after doing a search.  I just had my first Xiaflex shots on Friday...Yes, Friday the 13th. LOL!  Let me give everyone some background...My Peyronie's is / was severe.  My penis angled down at 90 degrees, which from what I was told is the rarer way for the penis to "point".  I had plaque in three places.  I still have scar tissue which has given me the hour glass look.  I was fortunate enough to be put under the care of Dr Tom Lue at UCSF.  He's an incredible and hilarious doctor.  My original urologist first put my Vitamin E for a slight curve to the left and down.  It did nothing.  He then put me on Trental, three times a day...It also did nothing, and in fact, my penis eventually bent to it's 90 degree angle.  It was then that I was referred to Dr. Lue.  Dr Lue did an ultra sound and then upped my Trental dose to two tablets three times a day (working up to that amount over a couple of weeks).  Trental can be a little hard on the stomach.  Anyway, this dose did wonders!  My bend went from 90 degrees to about 20 to 30 degrees.  Unfortunately, the length is still affected and the hourglass syndrome is pretty severe.  So, on Friday, I had my first shots of Xiaflex (Dr Lue doesn't put all of the medicine in one shot, he does several shots in the general area).  Let me tell you, the needle itself hurts and the push of the medicine puts a jolt of pain through the body!  Afterward, the effects hit my right away.  My penis was swollen, purple, and a little scary to look at!! LOL!!  Honestly, I haven't felt very good over the weekend and had it been during the week, I would have had to miss 2 or 3 days of work.  My next shot(s) are tomorrow and work is aware that I'll be out for a couple of day due to medical reasons!  I really hope this does the trick, but I don't think I'll get the lost length back.  I'll keep everyone posted.

I went in for my xiaflex "modeling" today.  I had the xiaflex shots last Monday and Wednesday.  It (the modeling) was intense, but tolerable.  The doc said he could detect "crackling" and "popping" in the plaque and he said it seemed like it had gone well.  I detected none of that as I laid there, but it was sure good to hear him report it.  I now have to do 30 days of stretching and bending per the written instructions I was given.  So far, so good.  I am still hopeful that it will help.

I was pretty sore and not feeling so great for a few days after the shots.  The aftereffects were worse than expected. 

Hello, all.  I have an update on my treatment. 

I had my second set of xiaflex shots on Friday of last week and this morning.  I then go back for two more in mid October and the last two around New years.  And that will be it.  I would say that the first two shots in June eliminated about 1/2 of the bend.  I was tempted to just let it go at that, but the insurance was paying for everything and my authorization was about to run out.  So I am back at it to get rid of the other half of the bend.

By the way, the xiaflex shots are pretty painful.  Or at least they were for me.  Stabbing pain for a few hours afterwards.  It was bad enough that i could not drive myself home last Friday.  An the black and blue/swelling of my little man?????   very, very......bad!!!!!!!!  Pretty horrible to glimpse when standing at a urinal.  But it does get better in a matter of days.

Wish you to be strait again biocob :)
Continue updating us, any information on the subject is very useful for other members.

james

I am headed in for round three of the shots next week Wednesday.  (two shots per round) The goal is to finish up all four rounds of shots by the end of the year.  I will report here on how it goes

Good luck biocob! I just finished round 1 on I'm still very black and blue and sore in spots 4 days later. If it works it will be worth it. Please keep us posted on your progress!

I was originally very put off from Xiaflex from photos I saw of the aftereffects.

But what both Knight and biocob seem to be saying is that most of that is cosmetic. Am I correct about that, guys?

 I would say it definitely looks much worse than it feels. But for anything that looks that bad there has to be something fairly dramatic going on. I am sore, but judging from the way it looks I would think I should be curled up in the fetal position begging for death. Of course I am kidding, but when my wife insisted on seeing the damage I showed her and I thought she was going to pass out.  :-\

But for the most part I've been able to do whatever I needed, or in most cases wanted to do. There were a few times the first couple days after the second shot I felt I needed to get off my feet and take it easy. But the night of the first shot I drove 2 hours and went grocery shopping with my wife after I got home. Two days after the second shot I went fishing in my boat for about 4 hours and now the 4th day after I just went to the gym and did a full body routine in the weight room.

It looks bad but I'm able to keep going. The mental part of it gets to me and makes me feel weak at times but I'm pretty soft when it comes to doctors, hospitals and needles. It's sore but manageable. No pain meds at all.

I would also like to share my recent Xiaflex experience.

After some success's with my earlier oral treatment I felt I reached a plateau and my penis did not completely returned to the straight and fullness shape pre-peyronies.
Following these forum threads closely I decided with my doctor Xiaflex was the way to go.

I just completed my first round yesterday and this time swelling was not as bad as first injection 3 days ago.

Thus far everything seems to be going well and I feel very optimistic this will get rid of remaining hourglassing and slight curvature.

My doctor stated in mild cases only one set of injections should do the job within a month or so.

However, I will likely be going for more since is approved by my insurance.

Will keep everyone posted and best wishes to all.

dfurman

Keep us updated. It will help other to decide (or not) to go in this way.
Wish you very good outcome.

James

Has Xiaflex treatment helped anyone with long term pain from Peyronies Disease? I thought maybe if the treatments worked on shrinking the plaque it might take the pressure off the nerves causing the pain.

Recently went back to doctor Metro to inquire more about Xiaflex and the results he's having.  He told me that Xiaflex will really only break up the plaque and reconfigure scar tissue, hence the reason for modeling after.  So it's most likely only going to help people with curvature.  Trying to get rid of indentations, banding, and shortening is unlikely.

Unfortunately things are getting even worse for me.  I've developed even more plaques and I really don't understand how.  I guess the worse things get the more vulnerable you are for developing new ones.

Another thing is my shrinkage is getting real bad.  It feels like my plaque at the base pulls in the rest of my penis.....really uncomfortable all the time.

bummedout -

I'm sorry to hear that your condition is worsening. I am also concerned about the possibility of additional or proliferating plaques.

Peyronie's is a pernicious condition, and Xiaflex is not a cure for it. However, in addition to helping with my curvature, Xiaflex has made my indentations less pronounced and improved overall rigidity. I also think that, when combined with modeling and traction, it could indeed improve length.

The one area that it is unlikely to help is with ED from to physiological causes (venous leakage, etc).

Mending,

What doctor are you seeing?

Thanks.

Dr. Mulhall

Ugh....had a bad experience with him.

From what I am reading on the forum, you are not alone bummedout

James

I went through the third round of xiaflex shots as of ten days ago.  Shot six did not go well.  I had some kind of reaction.  My guy swelled up like a dead animal carcass (huge! and purple and skin tight) and i came pretty close to going to the emergency room.  I got through that night with a gallon baggie of ice and pain pills and little sleep.  ten days later the enormous swelling is down by 2/3's, but still much swelling and tenderness.  my nut sack looks like the color of grape Kool Aid and i have pools of blood under the skin half way to my navel--very awful looking.  It is slowly getting better.  still very painful to the touch.  no idea if there is any permanent damage, but my doc says there won't be.

I have seen maybe 30 to 40% improvement in curvature through the first two rounds of shots.  Maybe even more after the third round.  I was pretty happy with the results and almost stopped at the second round--wish I had!! But I told my doc today that I am not coming back for the final fourth round of shots.  I don't want to go through that again.  that was terrible and scary in a way that is hard to describe.  my guy looked just like the pictures you can find on the net of bad reactions to xiaflex, but without the rupture. 

Good luck to all. 

Hello, I just had my first series of Xiaflex shots last week. I finally got approved buy my insurance. I've had peyronies for many years and have tried other treatments with no success. I was so exited to hear that Xiaflex was a new drug to help reduce the bend caused by Peyronies Disease. I did all my research before I decided to go ahead with the injections and was very skeptical about the outcome and side effects. I just want to let anyone know that is planning on taking Xiaflex it has been a very painful and scary process. I have hematoma's (blood clots) around the foreskin that I can't even look at from the doctor during the modeling visit. It felt like he was squeezing my cock with a pair of needle nose pliers for 30 seconds 3 times. So if your peyronies is manageable without pain and only cosmetically unappealing I would definitely reconsider the process. I'm sorry if I'm discouraging you I just feel you should know how my experience has been. Horrible and scary I just want my wang back the way it was without further damage from these injections. Good Luck

Johnnybricks

Keep updating us and don't be so scared after the first session. Most forum members had very good results from Xiaflex.

James

I am not sure if the formula has been tweaked around or chemicaly altered but I too just experienced very nasty side effects 2 days ago  on my 3rd shot (2nd round). Still recovering from massive purple bruising and swelling.

First set of injections went very smooth last month.

Maybe the doctors are still in learning mode?
Maybe the best results are when have "massive purple bruising and swelling?

James

The important thing is that bruising and swelling disappear in a week or so

I have been waiting over 2 years for today. Finally after a lengthy grievance process with my insurance carrier I was approved for Xiaflex injections. The problem was that my approval in August is only valid until the end of the year and my physician, Dr Gelbard was/is so overwhelmed with patients, his offices were not going to be able to get me my initial injection appointment until sometime in Jan 2015.

I called regularly to see if there had been any cancellations and was always disappointed. I finally reached out to the doctor himself via letter last week explaining my dilemma and he was able to somehow squeeze me in for the start of treatment before I had to endure another bout with my insurance carrier and get my treatment started before the deadline.

I went to his Burbank offices Monday for examination, 35 degree upward curve and penile retraction. Substantial scar tissue on top. For some time the retraction had become an issue forcing me to sit while urinating or possibly spray everywhere. I have lost about 2" in length, but could still function sexually (achieve orgasm) although semen had to be basically milked out. Luckily for me my condition had somewhat stabilized with no calcification about 18 months ago or Xiaflex would not be an option.

Since I live about 90 minutes from Dr Gelbard's offices on a good day with light traffic, I elected to rent a hotel room nearby for my initial injection today (Tuesday) being scheduled early morning and the bad weather. And I received my first injection of Xiaflex this morning.

I was told that there could be some swelling and bruising, especially after the initial injection, and that is no understatement. I drove home after and there was only a small bruise where injection(s) were placed. 12 hours later it looks like Tiger Woods took a tee shot and hit me right in the groin with his club. My penis and scrotum are almost black, with my scrotum the size of a baseball and penis very swollen. There is some discomfort and pain, but nothing like you would imagine after viewing.

I have to return on Monday for the second injection and again on Tuesday to go through a tutorial of stretching exercises to be normally be performed by patient after session is complete. Although due to swelling I'm pretty sure that will be postponed for several days. Session equals 2 injections a few days apart. Then I am to return in approximately 6 weeks for session #2 and so on up to 4.

So we'll see what happens and I will try and post updates here. I do encourage anyone who is taking the Xiaflex route to be be very pro-active. After contacting US Bioservices (company distributing Xiaflex) and answering some questions I was able to secure a grant of almost $6K for the medication and Auxullum (the manufacturer) also offered a very substantial discount to offset my out of pocket expense. After I make my insurance deductible (which is almost already met for other reasons) I may get the entire treatment completed for a nominal expense, albeit my monthly premiums are quite expensive.

US Bioservices also informed me that it is rare that patients do not complete all 4 sessions before completion.

I do hope that the bruising and swelling has peaked and will begin to subside by tomorrow. Best of luck.

 

pvpey

Wish you good outcome from the treatment.
Please continue updating us.

James

One of my biggest concerns are nocturnal erections after receiving the injections. I was awaken in horror from my sleep on two occasions the same day of the shots. Apparently a spontaneous erection pulled on the tender tissues of the corpora and it felt as if a knife had Ben put through it.
The pain was so excruciating I nearly passed out in the bathroom. Swelling and soreness followed the rest of the day. I frankly thought I had a rupture, luckily was not the case.
Anybody else experienced this?

Are there any drugs to suppress erections, at least first 48hrs?
I'll ask my doctor next time as this was pretty scary.

Ciproterone acetate, but you should start it several days before

An update after my xiaflex treatments this past year:  I went through three rounds of shots, for a total of six injections between June and November of 2014.  Injection #6 went very badly (as reported below), but I slowly recovered completely over two months.  The good news is that about 75% of my curve is gone.  The lump of scar tissue is noticeably smaller.  I am calling the treatment a success. The bad experience with shot six was enough to have me not going back for the final fourth round.  But even without that bad experience, I don't think I would go back.  I am happy with where I am now.  So the stuff can work, guys.  Just be warned:  it can have dramatic and awful side effects.  Brace yourselves!!

I wish the best of luck to all of you!!  May we all be straight!!

Thanks for the update and congrats on your success! I hope to join you as a success story before this is over!  I begin round 3 in about a month.

I second that biocob, congrats! It's so encouraging to finally hear real world tangible results after waiting so long for some type of solution.  Mind you, not a cure but close enough for now.

I had my 2nd cycle of Xiaflex Yesterday and today.  Just like the first time, no bruising at all after the first shot. After the 2nd shot, a totally different story. This time around seems much more swollen and black and blue early on. The doctor told me today to massage the plaque once I get home to help with dispersing the Xiaflex a little throughout the plaque.

I also used my traction device on both days immediately following the shots for a total of 4 to 5 hours on each day with several breaks in between.  I took the tension down slightly so I could handle the discomfort a little better.  it's so swollen now that it barely fits in the hole. I did not use traction in the first cycle and only started back up with traction 4 weeks ago. I'm on 2.5 mg of cialis so my night time erections are great. Tonight should be interesting considering the pain I'm feeling while flaccid. 

Before i received the 2nd cycle yesterday I showed my doctor a before pic of my erect penis prior to Cycle 1 and another taken one week ago. I hadn't looked at the pics side by side until that moment and it was clear there was at least a 10 degree reduction in curve. There was also some increase in girth above the hinged area, closer to the glans. I've heard that bruising is good...that could be something that doctors say to excuse bad placement of the xiaflex...who knows.  I will choose to believe it's a good thing for now and stay positive.

We early adopters are basically lab rats and the more we report our honest experiences to our doctors and more importantly here on this forum the better we all will be.  I lurked on this board for many years before I got up the courage to post. These boards were my sanity and solace when I needed it.

Thank you again for this incredible resource which is also my virtual group therapy session. Cheers.
Hope4all

Each to their own advisers but we were ordered not to use VEDs until two weeks after an injection.

Yeah, thanks Ive. There have been conflicting reports from doctors on whether traction with the xiaflex shots are beneficial and/or dangerous. I don't see an issue with traction since the protocol calls for the same kind of stretching, albeit for longer periods of time. The truth of the matter is, doctors don't really know since there hasn't been enough reported experience yet, and the manufacturer will always err on the side of being overly cautious to reduce their liability, especially here in the States.  I think VED would not be a good idea immediately after Xiaflex has been injected into the plaque, as it might be more likely to leak out of the plaque and not perform optimally. I was only able to use traction today for a couple hours because of my work schedule.

This time around the bruising is contained to the shaft and has not spread to the scrotum as it did last time. My night time erections last night were not an issue. When my erection woke me early in the morning, I did the straightening exercise as prescribed by my doctor. 

I agree with everything you say hope4all.

My attitude always is go (or not) with what your body tells you. Just would never personally recommend anything to someone else if it went against professional instructions.

Everything you guys are experiencing with Xiaflex is normal.  Are any/all of you also on Pentox/Trental?  That's what really helped me...It didn't help until I saw Dr Lue and he put me on two tablets three times a day (so 6 tablets).  It made me feel bad but it got rid of all the calcification and most of the curve!

Just finished my 2nd cycle of injections. My first cycle showed little improvement, but so far some improvement with my 2nd cycle. Anyway, I thought I would write about my experience for my 2nd cycle.

After enduring a temporary "Jesus, take me now!" moment while the shots were being injected, I was asked to check in with the lady at the desk in the waiting area. The waiting area was packed full of patients waiting on their appointments. The lady wasn't at the desk, so I stood there for a couple minutes waiting. She finally came out with both arms holding a stack of supplies and papers. I told her who I was and she says, "Oh...you're the guy that had the xiaflex injection today!" Did I mention that the room was packed?

I sheepishly and quietly answered "yes", and looked around the room for smirks. I prefer to keep folks guessing as to why I'm at the urologist's office. As far as I was concerned, she just as well could have taken a bullhorn and announced, "This man has a crooked penis!" After getting what I need from her, I put my head down and quietly mosey out of the room. When I reached the hallway, my childhood instincts kicked in and I ran the rest of the way to my car! I guess I'm still a child at heart!

Titandude:

WOW! What an experience! I know the feeling you must have had when it was broadcast all over the waiting room! Now, if it were me, I would have answered this:  "Hey folks, I have a crooked dick and it is all twisted up and I need to get the F~@
Anyway, the above is just a bit of humor for you. I had my first bout of Peyronies Disease at age 24 and later at 55 first bout of ED. Then at 65 had a radical prostatectomy which left me with urinary incontinence and wear a leakage pad each and every day.

Saying all of the above to help you ''get over stage fright'' when it comes to dealing with sexual health problems whatever they may be.

Keep the forum informed of your progress on the Xiaflex board so all here can have the benefit of your experience.

Old Man

Hello all-
I'm 60 years old, have had Peyronies with a pronounced 80 degree curve for about 8 month. I just underwent my 3rd round of Xiaflex, without notable improvement from the 1st 2. I'm getting discouraged. I do the required stretching for about 3-4 weeks post injections ,and have just sent for a penimaster, to add this stretching to my routine. I also take pentox 400 mg twice a day.
Any suggestions appreciated.
Thanks.

It sometimes takes several to see any improvement. Stick with it for a few more and don't get discouraged.

Thanks Les-
I wanted to check with those more experienced than I. I think the standard treatment with Xiaflex is 4 cycles. I read one of the postings that a fellow's insurance had paid for more. As we all know, Xiaflex is really expensive. Do others have experience with insurance companies paying for more than 4 treatment cycles? If so, I'd really like to hear how that was accomplished.
Thanks for any input on this.     

For those with calcified plaque. I sent an email to SOBI asking about this and received this reply;

"In short, we do not know if having calcified plaques makes any difference to the success or otherwise of Xiapex therapy"

"
This question has arisen before, and I can tell you that we believe that the reason for the exclusion in the trial population was that the calcified plaque might have made the injections more difficult or even impossible. "Effectiveness" was not considered at that time"

It then goes on to say that it is the decision of your Doctor whether Xiapex(flex) is appropriate treatment in your case.

So, they're not saying it won't work against calcified plaque, only that it hasn't been tried.

I had my first injection of Xiaflex earlier in the week. I have experienced swelling and tremendous bruising (a lot of black and blue throughout the entire part of upper shaft). I have woken up several times in the night with pain when experiencing erections. I will keep this post updated with my experience. I have my second injection early next week.

Hi. I'm new to this site.  I've had Peyronies for about 4 years and have tried a myriad of treatments including Pentox, Vitamin E, Co Q-10, topical Verapamil, an extender and so on with no success.  I've been looking into the Xiaflex, but frankly am rather hesitant after seeing some of the photos of botched Xiaflex treatments and reading some of the horror stories.  Does anyone know of a doctor in the southeast who has significant experience with Xiaflex and a good track record of success.  I've been to a couple of urologists in the Charlotte area, but they have had little or no training in Xiaflex and very little experience with it.  I don't want my penis to end up as a picture of another botched Xiaflex treatment.

Yeah, I'm pretty nervous about actually going through the Xiaflex regimen.

I had my second injection this week. Happy to report no bruising and minimal swelling and pain this time. Follow-up in 6 weeks to begin 2nd cycle of injections.

[Full quote remove be admin - Please read the forum rules regarding quotes]

JRB, you need to reach out to Dr. Culley Carson at UNC (Chapel Hill). He is a leading expert in Peyronies and close to you/Charlotte.

Does anyone know a good Urologist that has a lot of experience and a successful track record administering Xiaflex in northeast Florida? Thank you in advance!

Dr. Gregory Broderick - Mayo Clinic Jacksonville

Wayne J.G. Hellstrom, MD, FACS
Wayne Hellstrom
CONTACT INFORMATION:
Academic Office: (504) 988-5372
Clinic Appointments: (504) 988-2536
Fax: (504) 988-5059
Email: whellst@tulane.edu

Thanks, Charlie.  Looks like Dr. Carson is pretty experienced.

Thank you BX642 and northandeast!

JRB, he is a leader in this field, plus he does not overdo it with unnecessary (and painful) procedures. He is very good.

Just wanted to share my experience with Xiaflex treatment. Let me say off the bat id rather of stuck with the curvature. So I recieved my first injections on monday, all went well little bruising but nothing different from Verapamil injections. On wednesday I recieved my second round of injections at 5 pm at Dr. office. At 10 pm I got up to go to bed and somthing ruptured inside my little guy. Blood started filling him up to the size of an eggplant by the time I got to hospital. Had to go to ER cause the pain was so intense. They brought me rite in and gave me 2 shots of morphine which had no effect on the pain. Nurse said pain meds wont block it because its such a high degree of pain. Just shy of me passing out over it.  They gave me a quick ultra sound and confirmed it was all blood and liquid. Dr. Then gave me a shot of dilaudid which helped and decided to drain my dic. Yes drain my dic. 2 needles later and the fluid/blood shot out all over the nurse. After draining a massive amount of fluid I finally felt a huge relief. Stayed at hosp that night but it wasnt the hosp my Dr. Goes to. Next morning the hosp urologist evaluated me and said I have to go see my Dr. That did this so he can give treatment. Oh forgot to mention my little guy was wrapped in gauze. Got released from hosp and went straight to my Dr. Who i explained what happened to. He unraveled the gauze and my penis started to fill back up with blood again 😩. He rewrapped it real tight and said its a hematoma which is not uncommon. I decided to stay at his hospitl which was rite next door for 2 night just because it gave me a sense of comfort in the event somthing else goes wrong. Now im home and has been 2 days so far. Still wrapped up and my nuts are like a grapefruit not easy to get around thank god my fiance is a godsend and helps me alot. I see some improvement in bruising and swelling but my Dr. Said its gonna be a full month or more to be back to normal. I just pray I dont have complications later though Doc said I wont, who really knows. Ya know if ur a man a real man, u know that we can break our arm, leg, etc but when u injure ur manhood(penis) it breaks your spirit and really makes you depressed. I hope this helps out ppl who are considering xiaflex treatment. I have heard that it DOES work for peyroines but with obvious side effects. Good luck and god bless to all.

Outch! those are some serious side effects there... shame it happened such a thing, but indeed hope for the best; there might be a chance. Is the doctor you go to, a reputable one if i may ask?

Yes, really sorry to hear about your experience with the Xiaflex. It would really be helpful tp the group tp know who your doctor is and/or how much experience he has administoring the shots. Also if you can tell us a bit more about your particular case with respect to plaque size, location and degree of bend. Also where was the ill fated shot placed on your penis. Thanks so much and hope your recovery is swift!


Crooked_stick

Yes, many thanks for the factual description of what occurred, and we all hope that things return to normal -  no- that things get better than normal.

Odd that the first shot was fine, but the second one set it off.  Was it placed in a different area?

And like the others, it would be most appreciated if you could tell us who was the doctor you went to for the shots.

I had a similar issue which I documented in a separate thread. My first round of two shots went great. You could not tell anything happened at all. The next round I had my first shot, and my penis swelled due to bleeding, but the swelling was only about a half erection, nothing like the poster below. I went back for my second shot the next day but knew I would not get it due to my condition. My doctor said it was due to the fact that I probably was not putting pressure on the injection site right after the shot....i.e...i was pressing in the wrong area for 15 min after the shot.

We'll see next time (end of Dec.) if thats the case as I will be very focused on pressure at the injection site. BUT, as others have mentioned, it was very odd for the first round to be basically zero issue, and then have a bad time the next round.

So went back to my Doc today. I was scared to have him take off the gauze but was happy to see the swelling went down tremendously color is already coming back as well. Pain is still significant.  My Dr. Couldnt believe the healing results. He told me it was most likely a blood vessel that ruptured but we wont know for sure untill he can do a full exam when its healed better.  The Dr. I went to was Dr. Hendricks he has done xiaflex treatments before and just recently before treating me he treated 2 other guys with good results. I guess hes as experienced as one can be considering its only been out for a few yrs now for  Peyroines.  Im just happy its starting to look better gonna be a while yet untill my little guy is fully healed and to see if there was any long term damage which Doc thinks there wont be but who knows. 

If if is confident, at least you have some peace of mind. Best of luck!

Our bodies have amazing healing powers.

Thanks for sharing your experience and name of your physician.  Sounds like he's had good success in the past, and that this was just an anomaly.

Let's hope that your problem totally heals.  The fact that you're heading north so fast is an excellent prognosis for a full recovery.

So its been 44 days since my original post and my terrifying xiaflex incident. Well, I am happy to say im pretty much fully healed. Everything went back to normal. My little guy works just fine. Thank God... Still have a slight curve but way better than before not worried about it. It was a long and mentally challenging recover still ongoing but feeling much better about how everything. In conclusion I would say xiaflex works but be prepared that their could be serious side effects. Also make sure you do your research on Dr.s the injection must be done with perfect accuracy. Any questions feel free to ask. Take care and good luck...

Has anyone's curvature gotten worse after Xiaflex injections?  I am about one week out since my Xiaflex treatment and the curvature of my erection has gotten worse than before I had the Xiaflex treatment.  My doctor told me this is a normal thing a week in and to continue with modeling but I'm looking for others experiences and opinions on this.

Thanks

Yes mine did. I had two rounds and my curve rapture worsened and Dr. Lue stopped. Said I was his first to ever have that happen.  He thinks it's because I'm still in the Active stage.

Hi can i ask guys who've had xiaflex done - does this help with the hard flaccid state of the penis - or does that remain the same (for those who suffered with this too)?

Hi, Guys. Can anyone help me with one thing. I have Peyronie's. Now i start making verapamil injections. Im interesting, may I buy xiaflex, or xiapex somewhere in EU and bring it here to Russia to start treatment. What about prices. Is there any online store or somthing.

Meduza

I don't know where to buy Xiaflex or Xiapex in Europe, but I am proposing you to read on the forum as much as you can regarding Verapamil success before starting the Verapamil injections. At least you will know what to expect.

James

Hi,

Is Xiaflex recommended in the acute stage as well? I have been diagnosed over 3 months ago.

Meduza
I would discourage you from trying to source Xiaplex/flex and then using it and with an inexperienced doctor. I read a few unhappy stories on this forum about these injections going wrong, and I strongly suspect that it's not just a Xiaplex issue, but a doctor skill issue. Unless the doctor has many years experience of operating on Peyronies plaque, I wouldn't use him.  I and others have had good results from Xiaplex injections.

Quote from: Meduza on March 21, 2017, 04:27:03 PM
Hi, Guys. Can anyone help me with one thing. I have Peyronie's. Now i start making verapamil injections. Im interesting, may I buy xiaflex, or xiapex somewhere in EU and bring it here to Russia to start treatment. What about prices. Is there any online store or somthing.

DO NOT do this without an experienced doctor - or you may open yourself up to a whole other world of pain metaphorically and physically