Xiaflex

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j

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

ComeBacKid

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

ohjb1

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.  

ComeBacKid

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

MUSICMAN

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.

UK


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.



ComeBacKid

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

UK

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.
   

ComeBacKid

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

cowboyfood

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
Currently:  L-Arginine (2g), Vit D3)

Woodman

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.

UK

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.





ComeBacKid

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

LWillisjr

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.
Developed peyronies 2007 - 70 degree dorsal curve
Traction/MEDs/Injections/Surgery 2008 16 years Peyronies free now
My History

ComeBacKid

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

ohno

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.  

ComeBacKid

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

Bart2

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

Fred22

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.

LWillisjr

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.
Developed peyronies 2007 - 70 degree dorsal curve
Traction/MEDs/Injections/Surgery 2008 16 years Peyronies free now
My History

George999

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

j

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.

Ticker

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  

janvera

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?

Iceman

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

j

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.

Iceman

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

j

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.  

UK

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

janvera

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.

ComeBacKid

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.

MUSICMAN

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.

George999

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

j

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.

ComeBacKid

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

Iceman


ComeBacKid

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

Iceman

so when will we use it

cowboyfood

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


Currently:  L-Arginine (2g), Vit D3)

j

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.


ComeBacKid

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

j

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.  


George999

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

j

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.  


ohjb1

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.

 

ComeBacKid

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.


George999

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

j

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.


lizagill

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.

UK

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?