Xiaflex

[joe]

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

[ComeBacKid]

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

[j]

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.

[Iceman]

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??

[SSmithe]

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

[Fred22]

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

[SSmithe]

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

[Fred22]

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

[MedStudent86]

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).

[bummedout]

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.

[timk]

Here's an article in today's NYT:

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

[Fred22]

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                                                           

[ComeBacKid]

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

[j]

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. 

[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?

[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.

[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.

[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

[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.

[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.

 

[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.  

[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]

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.   

[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]

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.

[cowboyfood]

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

[Iceman]

so when will we use it

[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]

is this bad news?

[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

[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.

[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

[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.

[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.

[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.

[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

[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.

[Iceman]

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

[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]

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

[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?

[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

[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.

[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

[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.

[Fred22]

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]

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 

[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

[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]

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