Xiaflex trials are over, maker files with FDA for approval for pyronies

[doksoul]

http://www.4-traders.com/AUXILIUM-PHARMACEUTICALS-8493/news/Auxilium-Pharmaceuticals-Inc-Submits-Supplemental-Biologics-License-Application-to-the-FDA-for-X-15477046/  Auxlium filed with the FDA for 60 day approval of Xiaflex for pyronies use.  The article explains it all.  It details results of third phase trial.  Hopefully the FDA will move on this!!!

[james1947]

Thanks Doksoul, this is the news many of us are waiting.
Written 11/7/2012, maybe will be available at the beginning of the next year

James

[skunkworks]

Odd (stupid) that they were not tracking more things. Like length and erectile function.

[funnyfarm]

I was thinking the same thing.  Also, they only report info on improvement.  What if a portion get much worse on xiaflex, this does not get published !?

[james1947]

Auxilium are releasing just information that will help them to get back they money and eventually make big money

James

[MattFoley]

Guys, unless I'm missing something, Xiaflex can be used NOW for our problem. Yes, it's off-label but so is Pentox. Pentox is not labeled for peyronie's. Urologists give it to us because they think we can benefit.

I'm hoping to get an appt. to a peyronie's specialist soon and I will beg him to use it on me.

Also, if you are my age (late 40's), consider growth hormone replacement therapy and have your testosterone checked to make sure you are operating at peak levels. The body uses GH and testosterone to re-build damaged tissue.

If I have made any incorrect assumptions, please correct me. Thank you.

[skunkworks]

It can be, but the skill of the operator seems greatly important to success with the treatment. So it is not something you want to rush in to, as any injections in the penis have the potential to make the condition worse if the operator doesn't have steady hands.

[MikeSmith0]

Guys, unless I'm missing something, Xiaflex can be used NOW for our problem. Yes, it's off-label but so is Pentox. Pentox is not labeled for peyronie's. Urologists give it to us because they think we can benefit.

I'm hoping to get an appt. to a peyronie's specialist soon and I will beg him to use it on me.

Also, if you are my age (late 40's), consider growth hormone replacement therapy and have your testosterone checked to make sure you are operating at peak levels. The body uses GH and testosterone to re-build damaged tissue.

If I have made any incorrect assumptions, please correct me. Thank you.

You're missing a few things...

1.  Xiaflex is extremely controlled & only available from the manufacturer (and possibly specialist pharmacies but you have to register).  Auxilium (and any associated pharmacies) will not sell the drug to a urologist.  Every doctor who orders the drug must be screened and approved.  Only hand surgeons (orthapedic and plastic) can get the drug for DC.  It is not approved for Peyronies Disease and so no other doctor can get it.  Auxilium does not want the FDA hearing reports of off label use where things go badly (and compromise FDA approval), so they will not allow it to be sold to urologists.  
2.  Insurance companies will not reimburse for off label use.  That is going to cost you roughly $4000 per injection... trial subjects had 8 injections.  Do you have that much cash (assuming you could even get a doctor)?  If you lie to the insurance company and say you have DC - then the doctor is going to be at risk of insurance fraud.  Most doctors will not put themselves in this position.
3.  Any doctor who used this off label and made a mistake injecting your penis  with a drug that dissolves collagen on contact risks being  sued into oblivion and risks losing his license - since it is not FDA approved right now.  So you will not be able to find a doctor who will do this.  

This is not an off-label pill that has been used for decades like pentox... this is a very unknown injectable drug...and it's going in your penis.  

I found 1 plastic surgeon who said he'd do it for $4000 an injection... but he never actually tried to get it (i decided against it) - he made sure to tell me he was marking it up $1000 from the price he'd get it from Auxilium... nice, making $1000 for a 10 minute procedure.  Besides,  1 injection won't do anything... it doesn't even work that well after 8 injections.

[charlie44]

My Uro was involved in the trials and has been in front of the FDA regarding getting Xiaflex approved. I discussed this with him 3 weeks ago. He says it will take either six or 12 months from this past November (last month). Six months if the FDA expedites, 12 months if not. He argued for expediting, but as he said, you can't push the FDA too hard or they will take their time out of spite.

So basically worst case would be end of 2013 unless something goes wrong. Hopefully they do expedite and we would have access mid-year.

Let me add that my Uro is very pragmatic. He is the first to say this is not a cure and that people should focus on getting well enough to be functional (sexually), because odds of a complete cure are very remote. He also sees any type of surgery as the absolute last result. Reserved only when you are not functional whatsoever, and there is no other option.  

[TooYoungForThis]

Sigh, so even if they get approved there's no way I'll be able to afford it?


Well that's good news. Guess I'm stuck with Peyronie's forever regardless of what I do.

[MattFoley]

Don't give up. If you have insurance or some type of health coverage and Xiaflex is listed as a treatment for Peyronie's, the insurance company will have a very difficult time denying a necessary health procedure. It's gonna be a bit of a battle but there's great hope.

[skunkworks]

Just had my first injection of xiaflex yesterday (2nd trial). I went through a trial last year but received placebo (as I suspected). I'll try to keep up a running commentary as I go along this year. If anybody else is starting a trial now, please let me know. I'd like to compare notes.

No negative effects from the placebo injections?

[RoyHobbs]

Trials are still ongoing? I thought they were over.

[richard wheeler]

thats what i thought too. there was another post a couple days ago from another member saying he just started xiaflex after initilly getting the placebo. stay tuned,lol!  

[Hawk]

Unless I am missreading this, this is NOT a trial.  As a participant in any trial, those that get the placebo are usually promised the actual drug free of charge for participating in the trial especially when the tested drug shows a benefit.  

It would be a pretty raw deal to give a guy a placebo and tell him: "Hey, the trial was a great success all the guys with the drug showed great improvement, but since you got the placebo you are out of luck.  We will sell you the real stuff in return for your life savings however."

This is just the completion of that promise after the trial ended.

[dvdmaven]

I agree, Hawk, the positive PR they will get from the people who received the placebo will be worth the cost. Plus, it will almost double the number of cases they have documented.  

[TooYoungForThis]

Please, if they are going on how can I get into one? I can barely afford pentox and I'm dying!!!!!!!!!

[Hawk]

What we just said is: There are NO trials going on!

If you were in the trial and got the placebo, then they will live up to their legal agreement and contact you to give you the actual drug.

[RoyHobbs]

I just came across this. It's from a stock analysis website. But it's saying approval chances are high and a decision should be made by Sept.

Data on Auxilium's Xiaflex - Zacks.com

[MattFoley]

Nice. Let's hope that the FDA doesn't feel the need to wait so long.

[egghead]

Do insurance companies immediately agree to pay for FDA approved meds? Or is there a lag?  

[MattFoley]

Every insurance company is gonna be different.

However, in the end, the Xiaflex would be a medically approved procedure for Peyronie's that can not be ignored. The insurance company can not simply agree to surgery anymore without looking at the Xiaflex option. Surgery is a last resort option for Peyronie's and has always been. Now with Xiaflex, doctors will likely insist upon it as the initial therapy. I'm guessing it will probably give them a larger profit margin as well. So, it should all work out in the end for everyone.

The cost of Xiaflex should come down quickly enough.

 

[pointedly]

I went to the auxilium website and from there I went to the government website  www.clinicaltrials.gov , entered "peyronies" in the search box and read up on the Phase 3 trial.  I think this is what is referred to as the "marketing trial" by the pharma industry.  The enrollees are limited to those who have participated in the previous Auxilium trials numbered AUX-CC-803 or AUX-CC-804.  This study is expected to be concluded in October of 2013.

Not sure if this makes things any clearer or if this ground has been covered already...

[UK]

I went to the auxilium website and from there I went to the government website  www.clinicaltrials.gov , entered "peyronies" in the search box and read up on the Phase 3 trial.  I think this is what is referred to as the "marketing trial" by the pharma industry.  The enrollees are limited to those who have participated in the previous Auxilium trials numbered AUX-CC-803 or AUX-CC-804.  This study is expected to be concluded in October of 2013.

Not sure if this makes things any clearer or if this ground has been covered already...

Interesting , no this looks new. Maybe Auxilium realise FDA approval is still some time away and using this period for additional trial information or information they expect the FDA to ask for approval.

[Hawk]

Again, this is for only people already in the other trials.  I am sure it is for those getting the placebo the first time.

[pointedly]

Hawk,

Thanks for your insight - I am sure that you are correct regarding the placebo group.  The two groups in the study totaled 766 men and the placebo ratio was 1 in 3.  So 1/3 of 766 = 255 and the Open Label Study has an enrollment of "approximately 270."  I have further researched the term Open Label Study/Trial and that refers to the fact that everyone involved knows the treatment that is being administered (no double blind, placebos, etc..) - sorry I got my terms mixed up.

It looks like they will be collecting and submitting data for this trial and the estimated completion date is October 2013.  The study began in September 2012 and there is a 36 week (9 month) "final evaluation" visit required after the injection cycle.  IF the estimate is October 2013 for completion, that would have assumed that all 270 have received the injections by the end of January.  I am sure there will be some who are unable, unwilling or disqualified for other reasons, so a good question to ask is if Auxilium placed a deadline on injections for this additional Phase 3?  The 9 month clock won't start ticking (for data submittal purposes) until the last participant is injected...

[DO]

Another Xiaflex trial mybe about to start.... They want to use the drug with traction device in a clinical trial!!! Keep your eyes out on Clinical trials.gov  This time everyone may get the drug but no one knows as of yet! It is a rumor... but keep a look out!

[Hawk]

I think for those choosing VI and those that will go with Xiaflex, using traction is almost a no-brainer.  I actually feel almost as strongly about Pentox  If you are undermining the bands of scar tissue that cause the deformity, why wouldn't you apply traction to assist the process and further undermine the shorted most restrictive bands of tissue.

[pointedly]

After I applied traction, I had more plaque that was noticed by my uro at the point that the device pulled the end of my penis.  He could not rule out that the device caused additional injury or if it was the progression of the disease, but my curvature became more pronounced after I began traction (and more painful).

I have an Augusta VED that I have been using for about 5 months and have recovered about 3/4" of length.

I agree that it is a no-brainer that "tension" should help with interventional injection, but beware that not all traction devices are created equal...in my case the cure (of traction) may have been worse than the disease.

[doksoul]

Found new Article (4 Feb 2013) that says Xiaflex may be available in Sep 13.  I really don't understand the article about the effectiveness of the drug though.  Maybe someone else can translate it.

http://www.streetinsider.com/Corporate+News/BioSpecifics+%28BSTC%29+Announces+Publication+of+XIAFLEX+Phase+III+Data%3B+Will+Submit+sBLA/8056656.html  

Also here's the clinical abstract on it' efficacy:  http://www.streetinsider.com/Corporate+News/BioSpecifics+%28BSTC%29+Announces+Publication+of+XIAFLEX+Phase+III+Data%3B+Will+Submit+sBLA/8056656.html

[james1947]

Doksoul

The first link document deals with some publication politics and how the statistic was made, in the end stated:

FDA is expected to take action on the application by September 6, 2013

I don't know if "taking action" is approving it or beginning to discuss the subject.
The second document is same as the first. Maybe I am doing something wrong.

James  

[RoyHobbs]

I've got a google alert going for Xiaflex. Pretty easy to set up and you'll find out right away when it's approved.

[james1947]

My questin was (and it is) regarding the FDA approval:

I don't know if "taking action" is approving it or beginning to discuss the subject.

James

[RoyHobbs]

The FDA agreed to review the application which means the discussion regarding approval has begun. "Taking action" by September can be interpreted as a decision about approval will be made at that time. Subsequent rollout may not happen immediately after but it will happen if approved. Just in time for Christmas?

I mention the google alert because if you set one up you'll know as soon as approval happens. Any article mentioning Xiaflex is emailed directly to me.

[james1947]

RoyHobbs

Thanks for answering my question.
If it will be released for Christams it will be my birthday present, unfortunately can't use it as my plaques are calcified.

James