Just a basic question, should xiaflex work..
What is the possible timeframe it is possibly going to be avaible for "normal patients"?
I know nobody can tell for sure, but what is a realistic timeframe?
I'm asking because I am seriously thinking about getting surgery.
Why? because i am turning 55, I am single and have been through hell for the last 3 years.
And (midlifecrisis?) I just dont want to start dating "girls" again when i'm 60...
Waiting like another 2 years for xialis, is a complete no go..
(If you are in a stable relationship with an understanding partner it probably is completely different)
So can anybody give me an approximate timeframe, (if all the studies and tests are positive)?
Thanks to all
Luc
the curent trials including the latest - the open label - one are slated to wrap up next March. I'd guess around 18 months or so at the least? Just a guess for sure because I have no idea if Auxillium plans to test further, but I wouldn't think so......
Why not contact Auxillium and ask when they think it will happen? Some on the board here have contacted them in the past.
probably the end of 2012....the FDA can take a while after the study is done too...but it might not be that bad since it is already approved. 2013 might be the latest.
Thank you for the replies.
I will definetly contact auxilium
Luc
when do you think xiaflex will be approved and ready for the public?
by the end of 2012 I think it's a reasonnable scedule. As time goes by I consider it as a part of mutltherapy including ved, traction and pentox. All those things can makes the peyronie's symptoms milder and promote a better coping. I personnaly know that I will deal with peyronie the rest of my life, but with more lenght/girth and better erection it will be ok.
after phase 3, will it be ready for the public?
also if xiaflex dissolves scar tissue, wont their be like a gap of space? and the penis will lose girth, because normal penile tissue turns into scar tissue am i correct?
PEOPLE WERE SAYING IT WOULD COME OUT EARLY THIS YEAR! I NEED THIS DRUG WHATS TAKING THEM SO LONG!
DOes anyone else have serious numbness? i cant even really feel my penis anymore.
does anyone that have scar tissue inside of the corpus cavernosum have feeling?
i dont understand when i went to my neurologist he said he dosent think its nerve damage, but how can i be numb for the last past 5 years since my injury happened. i dont get it! I DONT WANNA BE NUMB ANYMORE!
i can feel the dent in my penis though when im erect and i can definitely feel the scar tissue.
it seems like i am the only person that has a numb penis with peyronies!
if someone injuries there corpus cavernosum does that mean that part will be numb forever?!
That really sucks, I've never heard of anyone else like that! When you get an implant the inside of the penis is destroyed to make space for the implant but the guys still have feeling.
yeah, i dont understand. its really depressing. like i cant feel my penis when i piss either.... like i can feel piss coming out of my bladder but i cant feel the piss coming out of my penis. =(
agent0
You need to see an uro specialised in male dysfunction. The neurologist may have good general knowledge regarding nerves, but he is not specialised in the nerves of penis I suppose.
I understand you can have an erection. When erected you feel numb also?
Just don't wait, I understand you have the problem 5 years already.
Why you think the Xiaflex will solve the numbness problem? As I understand from posts on the forum, it may be available by the end of the year.
James
yeah im numb when i have an erection too, the underside used to be so sensitive and now it almost completely numb.
im hoping maybe some scar tissue is putting pressure on the nerves, and if i get rid of the scar tissue i could be able to feel again. iv waited so long and it seems like xiaflex is the only cure i have. iv talked to someone that talked to dr lue, and he did say that scar tissue can put pressure on the dorsal nerve.
i really just wanna be normal again. thanks for replying james and worried guy.
I think alot of the nerves run along the tunica and into the cavernosum.if the tunica becomes inflamed and scarred this could effect the nerves. Im in the same postion... not really sure what i did but have recently been diagnosed with suspected peyronies.had symptoms for a while with ed and then through lack of knowledge made things a whole lot worse. now in constant pain for the last 7 weeks, lack of feeling, weak erection, cant get prescribed pentox. at 23 it really does suck......
yeah i feel you young brother im 25, just turned 25 on the 7th of this month. you can buy pentox online though. iv tried it, it helped blood flow, but it didnt help my numbness symptoms. and the scar tissue is still there. i need this injection. iv already waited 5 years i guess i can wait a couple more months.
I have been tempted to buy pentox online but would prefer prescription as you never really know what your getting. ive got an appointmet with a specialist feb 27 so im hoping for cialis daily and pentox. not really exspecting much in terms of a full recovery but a time where it was off my mind would be nice, i guess anything extra i would take as a bonus. since being diagnosed (suspected) ive read the forum daily, trying to learn as much as possible. i had hopes that this would be reversible but now im starting to see its more with acceptance and maintaing what you have. By this i mean if scar tissue is already present there is not really much you can do as scar tissue replaces normal tissue that has been damaged. getting rid of scar tissue wghat would there instead??? Its the same as anywhere else...a scar is a scar. this is where i get depressefe thinking of where i was, then hope and then....well... Not much else after that. dont get mr wrong im nevrr going to give up. if i can get an erection in whatever way possible and both me and my girlfriend are satisfied ill be happy but its not the same. i took it for granted before and id give anythin to be back there. no pain would be nice to.
I'm re-posting this from another thread. There isn't a clear date with any drug that goes through the FDA approval process. You can only estimate it. The main study ends in March of this year. Then the FDA still has to review it.. I have looked up the Dupuytren's trials to get an idea, below.
Here's some of the study info:
Joint I (Phase 3)
Study Start Date: October 2007
Study Completion Date: April 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Study Start Date: December 2007
Study Completion Date: May 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Cord II (Phase 3 - non US)
Study Start Date: August 2007
Study Completion Date: January 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
The "primary completion date" (when patients have their last visits) is March of 2012 for the Peyronies Disease studies, and for some reason the study completion date is supposed to also be in March, though it looks like it usually gets delayed based on the above. It appears that patients were done with their trials in the fall of 2008 and the FDA approved in in Feb of 2010. This is 17 months...and we can hope that it may be even faster given that the drug is already on the market. Then again, with this being in unknown territory (not many approved penis injections out there) - who knows if it will be shorter than 17 months.
So, my guess is that it will be on the market 12-18 months after March of 2012, which would be March of 2013 - September 2013. All anyone can do is guess.
This morning I had an appointment with the David Ralph's number 2 (Andrology in UK) who was actually in charge of the Xiaflex Trial in London.
He said that the results of the trial were "very good" and he is certain Xiaflex will be on the market in the UK "next year".
The bad news is that he said it definitely would not be available on the NHS and when I hesitated a guess at treatment costing between one and two thousand pounds his response was "something like that yes"!
so xiaflex comes out in 2013? anyone have an estimation on what month?
Quote from: Kempenstein on February 23, 2012, 10:53:13 AM
when I hesitated a guess at treatment costing between one and two thousand pounds his response was "something like that yes"!
What I read, as its the same stuff as Xiapex (the collagenase for dupuytrens contracture) the pricing would be quite similar.
For dupuytrens the whole treatment of injection series will cost around €5000,- (thats in euros) so around $6000.
But of course I could be wrong and they will have a complete different pricing (but I doubt it)
It's a shame it might not be available on the NHS. At least when it's finally more accessible we'll start to see more reports coming through and get a firm idea of what can be expected.
Will there be any guarantees that Xiaflex will cure your ANNOYANCE? How much are you willing to pay without any guarantees ?
As I understand from reading on Auxilium site, the results of the latest trial will be released in June.
If the results will be positive, they will go to get FDA approval.
Any availability estimation will be a guess, so to MikeSmith0 guess bellow:
QuoteSo, my guess is that it will be on the market 12-18 months after March of 2012, which would be March of 2013 - September 2013. All anyone can do is guess.
Will become December 2013.
Regarding paying without guaranties, we are doing that in many cases in many aspects of our life. So I will do everything I can to get my manhood back.
James
Hi guys
As I wrote in other Posts here, I'm 25 and have a fibrotic plaque caused by a Nesbit procedure in 2008. The problem is that the plaque got worse in 2010 when I had another surgical procedure (when the surgeon tried to remove "adhesions" in my penis always caused by the 1st procedure)
So I'm really worried that an injection can worsen the plaque and not improve the situation...
I don't want to put a penile implant, I still have erections but the penis does not lenghten as before the surgeries
I had an appointment with a leading Peyronies Uro yesterday. He was involved in the FDA Xiaflex trials.
He said the FDA will open the data on June 23rd, and then they have 6-12 months to approve. He thinks it might get approved on the quick side (six months) as it is the only medicine specifically being identified to treat Peyronies. So end of 2012 at best, mid 2013 at worst.
charlie44
Thank you for the information. Good news for many of us.
James
Sure, glad to help. Xiaflex is pretty much my last resort for hourglassing, since VI's did not do any good.
yeah im really praying that itl make my nerves come back and gets rid of this hard flaccid penis.
First for those that don't know,
xiaflex is marketed in Europe (and some other countries) by Pfizer under the trade name: Xiapex.Like xiaflex in the US, xiapex is an approved therapy for Dupuytren's contracture in the european union.
Now somehow Pfizer "screwed up" in february, by presenting insuficciant studies to the German Institute for Quality and Efficiency in Health Care:
(see article: http://www.thepharmaletter.com/file/111027/germanys-iqwig-finds-no-added-benefit-for-pfizers-xiapex.html)
Result:
QuoteIn an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether US drugs behemoth Pfizer's (NYSE: PFE) Xiapex (collagenase extracted from Clostridium histolyticum) offers an added benefit in comparison with conventional regimens for the treatment of Dupuytren's contracture.
However, such an added benefit cannot be inferred from the dossier, as the drug manufacturer presented either no data or unsuitable data on the drug, which is approved in Europe for this condition (The Pharma Letter March 31, 2011), the review body concluded.
Ok, that means that Xiapex will in future not be covered by med insurance in Germany. (I thought: big deal, i'll pay for it and I dont live there, I'm in Austria, maybe it will be a different situation). Actually it only means that Pfizer has to renegociate pricing with med insurance companies. But i also read, date from may 16 2012, that Pfizer refuses to do so:
Pfizer takes Xiapex from the market which means Xiapex (= Xiaflex) is no longer available on the german market since may 16th.
here the article from the german pharmacy journal:
http://www.apotheke-adhoc.de/nachrichten/markt/pfizer-nimmt-xiapex-vom-markt
(now this article is in german only, in quote a rough english translation of the main info)
QuoteBerlin -
After Boehringer Ingelheim and Eli Lilly have withdrawn Trajenta (Linagliptin) from the market, Pfizer is taking it's first drug from the market. Starting this wednesday the sales of Xiapex are stopped in Germany because Pfizer refuses to renegociate pricing with the Health Insurance associations.
The medication ist taken completely off the german Market. Pfizer has notified wholesalers and pharmacists it is taking back any stocks.
OK this is for Dupuytren's contracture only.
But in the US, once xiaflex is approved for Peyronies Disease, it will be easy to be purchased. As a doctor will only have to prescribe it and inject it. It is already available!!!
In Germany, it will not be on the market. Additionally Pfizer will have to prove it has an added benefit to surgery. (special targetted studies etc.) And it will not be reintroduced to the market that easily.
So probably here we will have to wait much much longer for it for Peyronies Disease. And it will probably never be even partially covered by med insurance :-\ . And as austrian market always follows german market, i am also concerned.
Luc
Bad news indeed.
The big guys are fighting and we are suffering!
Pfizer don't present enough data to the government or the government have other agenda.
Pfizerdon't ready to renegotiate prices with the insurance companies, one of them want to make more money.
Sad, really sad.
James
Interesting article Luciano and well found ... I did some looking myself off the back of this and found this from last month:
http://www.pharmatimes.com/Article/12-05-15/SMC_green_light_for_Pfizer_s_Xiapex.aspx
again, this relates to Dupuytrens but the approval process is what we're looking at here and the supply of the drug ... In Scotland it has been approved for NHS (govt. heatlh care) use which I find most surprising ... good news obviously, but surprising ... this reversed an earlier decision not to approve it for NHS use in Scotland ... I understand that it is fairly normal for drugs to be available in somre EU countries and not others ... I suspect it is down to profitability ... I think if Xiapex is approved for Peyronie's use you would be able to find an EU country that offers private treatment of some sort ...
Yeah.. I guess we will be able to find it for private treatment.. but if I recall correctly, the pricing will "aproximately be that of surgery".. which can reach easily € 15000.-
http://ir.auxilium.com/phoenix.zhtml?c=142125&p=irol-newsArticle&ID=1701869&highlight=
However, it could be up to a year before the FDA grants them a license.
I got an email about 4 weeks ago from a research company wanting to talk with me about peyronies. They had read my blog and wanted to asked me some questions.
I sent them my phone number and the rep called and we chatted for about an hour. Come to find out they are involved with Xiaflex. He told me that it is showing a 44% improvement for men with a peyronies curve. He was excited about this. Then I busted his bubble, and told him a 44% improvement would not help most men. Then I asked about those with peyronies for over 18 months would it help them. He did not have and answer. Just a 44% improvement in men still in the active phase.
I busted his bubble again telling him that there were about one third of men with peyronies, like myself, that the curve straightend of its own accord within 18 months. Had they taken that into consideration. Again he did not know and got disinterested in talking with me. He said he would call me back in a couple of days. I have not heard from him.
Jackp
http://jackp-penileimplant.blogspot.com/
Jackp
He will not call again, not in a couple of days, weeks, moths and years also. ;)
You made him very disappointed and mad >:(
By the way the improvement is 37% and yes, calcified plaque was excluded from the trial to improve the results. 8)
Myself is out, my plaques are calcified :( :( :(
James
I have come to the conclusion that Xiaflex is nothing but a "Scam". There is a lot of $$$ involved in this business. Xiaflex has a half-life of approx 24 hours and will only impact the plaque close to maybe 2-3 mm from the injection site. I know that many men has a string of plaque along the shaft from the top to the base. How many injections is necessary to dissolve all of that? The plaque is only a symptom of an underlying "unknown" condition. Without understanding/removing this underlying condition there will be a recurrences of new plaque - that´s my opinion!
ThisWontWork
I share your opinion regarding:
QuoteThere is a lot of $$$ involved in this business
Lets not forget also that it the Xiaflex group the improvement was 37% and in Placebo group 21%!!! The stretching that followed may be the main factor. Also calcified plaques are out (myself included) :( :( :(
and also:
Quotemany men has a string of plaque along the shaft from the top to the base. How many injections is necessary to dissolve all of that? The plaque is only a symptom of an underlying "unknown" condition. Without understanding/removing this underlying condition there will be a recurrences of new plaque
Maybe some doctors should try to do the stretching with the "pop" noises using Verapamil?
To remain in an optimistic mood, many on the forum had posted positive results :) :) :)
James
so does anyone think that xiaflex will come out by the end of this year?
Taking in consideration that in June 4, 2012 Auxilium has stated:
QuoteAuxilium plans to file a supplemental Biologics License Application (sBLA) with the FDA seeking approval for the potential use of XIAFLEX in the treatment of Peyronies Disease by the end of 2012. If approved by the FDA, XIAFLEX is expected to be the first biologic therapy indicated for the treatment of Peyronies Disease.
&
FDA approval may take six to 12 months, in my opinion Xiaflex will be earliest available July 2013.
James
Quote from: charlie44 on May 31, 2012, 09:14:35 AM
I had an appointment with a leading Peyronies Uro yesterday. He was involved in the FDA Xiaflex trials.
He said the FDA will open the data on June 23rd, and then they have 6-12 months to approve. He thinks it might get approved on the quick side (six months) as it is the only medicine specifically being identified to treat Peyronies. So end of 2012 at best, mid 2013 at worst.
so according to charlie since the drug was given to the fda on june 23, then we just have to wait 6-12 months from june 23 right?
"Additional Clinical Indications for XIAFLEX:
Auxilium expects to submit a supplemental Biologics License Application (sBLA) filing to the FDA for XIAFLEX as a treatment for Peyronie's disease by the end of 2012. If approved by the FDA, Auxilium expects to launch XIAFLEX as a treatment for Peyronie's disease in the U.S. in late 2013."
-Excerpt from article published 8/10/2012: http://www.sacbee.com/2012/08/09/4709000/biospecifics-technologies-corp.html
I understand as addboy understand it from what I have read.
If Auxilium will apply to the FDA by the end of 2012 (we have to see if will applay), Xiaflex will be available somewhere between July and December 2013.
James
omg july to december of 2013! thats like another year....F~@
how can i find out when xiaflex gives there information to the fda?
agent0
What I am doing to update myself regarding Xiaflex is googleing ones a week for Xiaflex and Auxilium.
This is the best chance, in my opinion to be updated. If I find something, I am updating the form.
James
thx james
when is xiaflex coming out. im so sick and tired of being numb..... :(
man i hope this works. i really need this to work, i dont wanna suffer anymore. so im guessing alot of other people with peyronies have problems with numbness too?
i need this cure, maybe my nerves are not damaged and scar tissue really is putting pressure on the nerve.
atleast its almost 2013 the cure is supposed to come out in 2013 right?
Sorry, I didn't find any newses regarding Auxilium applying to FDA. Still in the status:
QuoteAuxilium plans to file a supplemental Biologics License Application (sBLA) with the FDA seeking approval for the potential use of XIAFLEX in the treatment of Peyronies Disease by the end of 2012.
Lets hope between June and December 2013 :)
James
thx for answering james :)
Lets be cautious about referring to Xiaflex as a cure. It is a treatment with mixed results.
Yes, mixed results but still gives hope for 37% of the people that will make the Xiaflex therapy. :)
Excluding people like me with calcified plaques :(
James
do you guys think xiaflex is actually destroying the scar tissue or do you think its just making it more flexible, so the scar tissue isnt as stiff?
like my lump is right in the middle of the base of the shaft. i can definitely feel it. you guys think the xiaflex injection can go that deep to get to the scar tissue? my uro even said the scar tissue was really deep. if i can only just get rid of that lump...i think all my feeling will come back.
I was not in the Xiaflex trial, but I don't think that the distace to the skin is an issue. It depends on the needle length and doctor skill.
My private opinion.
James
Can someone post the link the to the board and topic where men who are in the current or most recent xiaflex trials willingly came forward and posted about their results, I don't see it.
Thanks,
Comebackid
Xiaflex is a treatment ready now for people with Dupuytren's contracture. If you have a urologist that will "cooperate" with you and has had experience with Veraparmil, perhaps you can convince him to conduct a procedure that is "off label".
I think a doctor to whom you are paying cash, might be the appropriate person for something like that.
Just a thought.
Not sure what kind of cooperation you are looking for. I think the fear of a law suit for using a drug for a non approved purpose will keep most reputable docs from "trying it". ;-)
My urologist (Larry Lipshultz, Baylor urology, Houston TX) was in the xiaflex study. He added my name to the list to contact when it becomes available.
Some of the phase 3 study results were just presented at a sexual medicine conference in Chicago. I do not know that the full proceedings have yet been published. World Meeting on Sexual Medicine 2012 - World Meeting on Sexual Medicine 2012 (http://www.issmsmsna2012.org/site/)
The Auxilium site says they expect to file for FDA approval to use Xiaflex for peyronie's disease before the end of this year.
Auxilium Homepage (http://www.auxilium.com/)
http://ir.auxilium.com/phoenix.zhtml?c=142125&p=irol-newsArticle&ID=1728655&highlight=
Auxilium plans to file a supplemental Biologics License Application (sBLA) with the FDA seeking approval for the potential use of XIAFLEX in the treatment of Peyronies Disease by the end of 2012. If approved by the FDA, XIAFLEX is expected to be the first and only biologic therapy indicated for the treatment of Peyronies Disease.
June 4 2012 Top Line Phase III results
Shows Q3-Q4 2013 potential FEA approval of Xiaflex for Peyronie's disease and launch
so when will this treatment be ready for actual use......
Auxillium says Q3-Q4 2013 potential FDA approval of Xiaflex for Peyronie's disease and launch. This applies to the U.S.. They don't say anything about other countries, where it is marketed by Pfizer.
Quote from: Iceman on October 26, 2012, 10:12:29 PM
so when will this treatment be ready for actual use......
so a person would have to go to the US to get treatment if it is approved in 2013 - how much would this cost and how long does this all take???
I feel that I am getting no where with the meds or VED - Ive been taking pentox and COQ10 etc etc for the past 3-4 years now and sweet FA has happened - total waste of time and money......
total bummer!
ComeBacKid
The two links bellow:
UK Xiaflex Trials - Peyronies Society Forums (https://www.peyroniesforum.net/index.php/topic,1558.0.html)
Thread for Guys in Xiaflex Trial - Currently or Previously - Peyronies Society Forums (https://www.peyroniesforum.net/index.php/topic,1458.0.html)
You will have to filer them.
&
Quote from: MUSICMAN on August 31, 2011, 01:01:14 PM
James
does anyone know if there will be clinical trials of xiaflex in Australia?? - i would like to try
I try to find out what happening with Xiaflex in general, I understand that the trials are over and they will release sometime in the near future the full report of the trials.
James
Look at this post, just down the page from yours, and the one before it. The study is there and links to the Auxillium site.
When Xiaflex will be available - Peyronies Society Forums (https://www.peyroniesforum.net/index.php/topic,1676.msg40329.html#msg40329)
Quote from: james1947 on October 28, 2012, 10:38:24 PM
I try to find out what happening with Xiaflex in general, I understand that the trials are over and they will release sometime in the near future the full report of the trials.
James
BrooksBro
I read your post in the link when you have posted it and downloaded and read the PDF file. It is indeed the newest information regarding Xiaflex timing.
What I am saying is that I didn't find mentioning that will be an additional trial for Xiaflex.
We hope they will apply to the FDA before the end of this year as they have written and get approve it during 2013.
James
Hi guys
I would just like to be clear about this drug.
From what I understand, have researched, and have been told by my urologist, Xiaflex will only actually work in people who are in the acute phase i.e. around the first six months. Anything after won't work - so that means for every person currently on this entire forum? (as by the time it comes out - anyone on here willbe well over the 6 month phase).
Is this correct? Or is there a chance that by the time the drug comes out, someone like me, who will have had the condition for at least a year and a half, may still be able to benefit from the drug, if their plaque has not calcified? Or does plaque always calcify and immediately after the 6 month acute phase?
If this is the case, how do I know if my plaque has calcified? Is there a chance that in some people that plaque never does calcify?
I cannot feel presently any notes or modules, but why do you feel are several I would describe them as phone lines of string that one from the base to the top of the head - is that calcification?
Kind regards
Luke
The exclusion from the trial was for calcified plaques only and not related to how long time you have Peyronies.
Early treatment will ensure (in most cases) in my opinion that the plaque will not calcify so you will be candidate for Xiaflex treatment.
James
There are several types of "calcification." A color Doppler ultrasound can determine if calcification has occurred, and the type that is present. After the drug becomes available, I expect there to be fewer exclusions than were imposed for the studies.
Oh wow! this has given me a glimmer of hope - provided i don't yet have calcification!
grrrr! this is like a full time job having to keep up woth all the latest info, treatments, drugs and ved etc
I'm going to aks for an ultrasound and hope i don't see any calcification - if i dont at least it will give me some hope.
ps apologies for my some of my post not making grammatical sense below - i typed it using voice recognition on my mac and forgot to check it for sense afterwards.
Thanks
Luke
lukewill
Not connected to:
QuoteI'm going to aks for an ultrasound and hope i don't see any calcification
Begin some treatment like VED and oral supplements/medications to increase your chance with the Xiaflex.
BrooksBro
Thanks for the information. I didn't know that have different kind of calcification's and I was sure I am out from Xiaflex treatment.
I will see if have around here a color Doppler ultrasound, mine was done black & white.
James
how does one know if one has calcification.
I have had Peyronies Disease now for well over 4 yrs and im sure that I must be in the mature phase of this - Im sure it must be calcification - if this is the case then xiaflex WONT work for me...is this true???
My uro made me the ultrasound and told me that my plaques are calcified. If I am not wrong, it shows more white if it is calcified. This is how I know that my plaques are calcified.
Regarding Xiaflex, I hope BrooksBro is right
QuoteThere are several types of "calcification." A color Doppler ultrasound can determine if calcification has occurred, and the type that is present. After the drug becomes available, I expect there to be fewer exclusions than were imposed for the studies.
In the Xiaflex trial calcified plaques were excluded.
James
November 07, 2012
sBLA Submitted for Xiaflex for Peyronie's Disease
Original Source: http://www.empr.com/sbla-submitted-for-xiaflex-for-peyronies-disease/article/267299/ (http://www.empr.com/sbla-submitted-for-xiaflex-for-peyronies-disease/article/267299/)
Auxilium Pharmaceuticals announced that it has submitted a supplemental Biologics License Application (sBLA) to the FDA for Xiaflex (collagenase clostridium histolyticum or CCH) for the potential treatment of Peyronie's disease (Peyronies Disease). Xiaflex consists of a highly purified combination of two subtypes of collagenase, derived from Clostridium histolyticum, in specific proportion. Together, the collagenase sub-types work synergistically to break the bonds of the triple helix collagen structure more effectively than human collagenase.
The sBLA submission is based on data from the clinical studies known by the acronym IMPRESS – The I nvestigation for M aximal P eyronie's R eduction E fficacy and S afety S tudies – and other controlled and uncontrolled clinical studies, in which over 1,000 Peyronie's disease patients were enrolled and received over 7,400 injections of Xiaflex. In the two Phase 3 double-blind placebo-controlled IMPRESS studies, Xiaflex demonstrated statistically significant improvement in the co-primary endpoints of penile curvature deformity and patient-reported bother vs. placebo. In IMPRESS I at 52 weeks, the co-primary endpoints met statistical significance with a 37.6% mean reduction in penile curvature deformity for Xiaflex subjects (P=0.0005) and a 3.3 point improvement in the Peyronie's Disease Questionnaire (PDQ) bother domain for Xiaflex subjects (P=0.0451). In IMPRESS II at 52 weeks, the co-primary endpoints met statistical significance with a 30.5% mean improvement in penile curvature deformity for Xiaflex subjects (P=0.0059) and a 2.4 point improvement in the PDQ bother domain for Xiaflex subjects (P=0.0496).
Xiaflex for the treatment of Peyronies Disease was granted orphan drug designation in by the FDA in January 1996. Auxilium has requested Priority Review designation for this sBLA submission.
Xiaflex is approved for the treatment of adult Dupuytren's contracture patients with a palpable cord.
For more information call (877) 663-0412 or visit www.auxilium.com (http://www.auxilium.com).
My Uro did trials and was in front of the FDA pushing for fast track approval. Saw Uro last week, and FDA did not Fast Track...so usually that means a year for approval. So looking at late October for availability at this point.
It might be good if this means the FDA will look at this more carefully. Personally I am not convinced Xiaflex is a safe option for treating Peyronies Disease right now.
The drug is derived from Clostridium histolyticum, a bacteria that induces necrosis in wounds. We know it helps some some guys, but the drug maker did not disclose details about the guys that got worse. So similiar to surgery I would consider it a last line of defense. And I would not want to be one of the "early adopters". It will take a number of years to figure out the optimum dosage, frequency, and which doctors have the best technique/results.
We're looking at FDA action by September 6, 2013.
I really hate the FDA.
Quote from: funnyfarm on February 03, 2013, 06:04:42 PM
It might be good if this means the FDA will look at this more carefully. Personally I am not convinced Xiaflex is a safe option for treating Peyronies Disease right now.
The drug is derived from Clostridium histolyticum, a bacteria that induces necrosis in wounds. We know it helps some some guys, but the drug maker did not disclose details about the guys that got worse. So similiar to surgery I would consider it a last line of defense. And I would not want to be one of the "early adopters". It will take a number of years to figure out the optimum dosage, frequency, and which doctors have the best technique/results.
I don't think not fast tracking it is due to the drugs potential negative side effects, I think it is more of a case where the FDA thinks surgery is a viable option, so no need to fast track....even though surgery is a last resort.
so does this mean that if you have had Peyronies Disease for many years, then xiaflex wont work??
Some of the experts say that plaque begins to calcify after 18-24 months. But there are others that claim that they have had plaque for years but it never calcified. So the real question is not the length of time, but rather do you have calcified plaque or not. And if Xiaflex will be effective or not.
I think only an examination and testing by your doctor would be required first and then your doctor can help determine if Xiaflex is a possible treatment for you.
how do i go about getting this tested etc etc - when will it become available in australia?
i have a appt with a uro in sydney ( dr malouf) - would he know the answer OR are there specialists in Aust who are more up to speed on xiaflex treatment options.
If xiaflex breaks down the plaque that blocks blood flow, does this mean that erections will be harder due to restored blood flow to the penis?
The plaque is like a rubber band around your penis, so constriction of blood flow is taking place. So yes, it's a possibility that you might see an increase in blood flow. But like every other treatment there's no guarantee.
This article restates what we've been hearing. The FDA is expected to make a decision on the approval of Xiaflex by Sept 6th.
BioSpecifics Technologies Corp. to Host Conference Call to Report First Quarter 2013 Financial Results on Friday, May 10, 2013 - MarketWatch (http://www.marketwatch.com/story/biospecifics-technologies-corp-to-host-conference-call-to-report-first-quarter-2013-financial-results-on-friday-may-10-2013-2013-05-03)
Treatment for Painful Curved Penis Shows Promise - Erectile Dysfunction Center - Everyday Health (http://www.everydayhealth.com/erectile-dysfunction/0508/treatment-for-painful-curved-penis-shows-promise.aspx?xid=aol_eh-mens_9_20130506_&aolcat=HLT&icid=maing-grid7%7Cmain5%7Cdl2%7Csec3_lnk1%26pLid%3D310785)
Here is a link to a story I just spotted on AOL about Xiaflex. Most important, it sets the approval date as Sept. this year. Confirms what we have heard.
Hey guys! I've had an appointment today with my Urologist, he just came back from the States (both me and my urologist live in Argentina). He was in a big meeting with Dr Levine and other urologists and he told me that Xiaflex was approved. Actually he didn't say "Xiaflex", he mentioned the drug "collagenase". So I asked him, "you mean Xiaflex?", and he said, "Well, Xiaflex is one of the brand names".
As a side note, he told me that he talked with Levine about Propolis (which I'm taking besides the Pentox) and that Dr Levine laughed, "do you really think that would help in any way?".
Quote from: betseyagopian on May 17, 2013, 02:57:41 AM
Hey guys! I've had an appointment today with my Urologist...he told me that Xiaflex was approved. Actually he didn't say "Xiaflex", he mentioned the drug "collagenase". So I asked him, "you mean Xiaflex?", and he said, "Well, Xiaflex is one of the brand names".
It was not approved for Peyronie's disease yet. It was approved in 2010 for dupuytren's contracture. It will not be approved until mid-September or later. There are no news releases about it being approved, and Auxilium would have something out if it were the case. You can see they are already gearing up: Banner 1 - Landing (http://askaboutthecurve.com/welcome) - which is sponsored by them now... but the drug is not available to urologists yet. Forecasts of dates are here (mid sept):
Auxilium Pharmaceuticals Inc: Testim Wins Patent Challenge, Cuts Generic Risks | iStockAnalyst.com (http://www.istockanalyst.com/finance/story/6372404/auxilium-pharmaceuticals-inc-testim-wins-patent-challenge-cuts-generic-risks)
The writer really breaks it down.
His final conclusion? Very close call but he thinks the risks outweigh the rewards and the FDA will not approve Auxilium for treatment of Peyronie's.
Auxilium Prediction: FDA Rejects Crooked Penis Drug - TheStreet (http://www.thestreet.com/story/12017590/1/auxilium-prediction-fda-rejects-crooked-penis-drug.html)
We will know September 6Th if the FDA approves Xiaflex for peyronies. The people at Xiaflex are confident of the approval that is why they are spending so much on Peyronies Awareness.
I can't tell you all I know about Xiaflex due to a confidentially agreement when we did the video of my story. I will tell you that most peyronies specialist say there is a place for it in peyronies treatment.
There are many men that would benefit from Xiaflex. We need all the help and awareness we can get.
Jackp
http://jackp-penileimplant.blogspot.com
I did participate in the trial phase 3 and got the real stuff. At the screening I had a deviation to the left of 70°. After 4x2 injection the doc could measure 60°. I think Xiaflex is a scam. The stuff is over 30 years old - why didn´t the inventor bring it to the market? You tell me!
Auxilium is only interested in your $$$ ! millions of $$$ ...
After the trial I started with Pentox, Larginine, CoQ10 and some Chinese stuff. Now after 16 month my fellow downunder is almost straight again.
I must add I have had some VED exercise too.
What Chinese stuff?
Some kind of Chinese herbs. Small brown/black pills. 8 pills 3 times a day. I ´ve got them from a friend living in Bangkok where a met a real Chinese doc. Don´t know the active ingredients.
Any lenght and girth gains TWW?
I don't want to threadjack, but I would be cautious about taking Chinese herbal remedies. I have some familiarity with that field from my work and it is an industry rife with corruption and quality issues. I would rather wait a few years for a drug like Xiaflex to be tested and approved than take something of unknown composition that could be harmful.
-Skjaldborg
I have to agree with Skjaldborg. I've taken alot of herbs over the years and some have had some bad side effects. Regards Inkhorn
Here's another link to a stock analysis that believes it will be approved. It's a mobile link, FYI.
Seeking Alpha (http://m.seekingalpha.com/article/1659162)
From Skjaldborg:
QuoteI would be cautious about taking Chinese herbal remedies
Maybe snake oil will help? (to make the sales man rich ;D)
From the other side, I used TIENS herbal capsules that after 3 months cleared all the many stones I had in both kidneys.
It not helped me with the bladder stones, don't know why.
As you say you are familiar with the subject, I would like to ask your opinion about TIENS
I know we are "off topic", I will split later the subject from Xiaflex.
James
Bad news bears. It's delayed until Dec 6th.
Auxilium: Goal Date for Xiaflex Extended by Three Months - WSJ.com (http://online.wsj.com/article/BT-CO-20130828-704113.html)
Wtf are you serious? What does this mean? Is something wrong?
Looks like it has been delayed:
Auxilium Receives Notification of XIAFLEX(R) PDUFA Extension - WSJ.com (http://online.wsj.com/article/PR-CO-20130828-903870.html)
Not sure what this means. The FDA needs more time to look at the results.
Auxillium filed an amendment to their application within 3 months of the original approval date, Sept 6th. The FDA deemed it a major amendment filing which triggered an automatic extension.
It does make you wonder why they felt the need to submit additional statistical data. This is purely speculation, but you're not usually offering additional evidence unless approval is in doubt.
It might have something to do with the pictures that were floating around here a while back. I know they scared me enough that I don't know what I think about Xiaflex any more.
Yeah but in regards to the pictures they represented three patients out of 500 plus?? And they were mentioned in the stock analysis write ups posted a couple of days ago. I think more likely is that the FDA is trying to determine how effective the drug really is, thus the additional information submitted. But again, I'm not an expert.
Hey guys:
This sounds like old times with the other company who tried to get this approved, but failed and passed the project on to their subsidiary.
Sorry to pour cold water on the many guys who are waiting with bated breath for this med's approval by FDA. This dates back almost 20 years now for this medicine to be brought to the table for its use.
The success rate for its use with Dupuytren's Contractures has also not been that great according to my personal hand ortho surgeon. So, hope that it can be approved soon for those vitally interested in its use for themselves.
Old Man
http://ir.auxilium.com/phoenix.zhtml?c=142125&p=irol-newsArticle&ID=1850220&highlight=
bummedout
Thanks for the update. Sad news for people waiting for Xiaflex, an other three months :(
I just don't understand who is playing. Auxilium or FDA?
James
Quote from: metoo2 on August 26, 2013, 06:21:18 PM
His final conclusion? Very close call but he thinks the risks outweigh the rewards and the FDA will not approve Auxilium for treatment of Peyronie's.
Auxilium Prediction: FDA Rejects Crooked Penis Drug - TheStreet (http://www.thestreet.com/story/12017590/1/auxilium-prediction-fda-rejects-crooked-penis-drug.html)
This analyst is either misleading (maybe has a short position in the stock), or doesn't have a good understanding of statistics. He says "The placebo-adjusted difference is small but still statistically significant with a p value of 0.0451. A p value greater than 0.05 would have been a negative result so this study barely passed."
Wrong. A p value of greater than .05 would simply mean the result isn't statistically significant at the 5% significance level, meaning there's not a 95% chance the conclusion is right, based on the sample size and results of the study. P-value is highly dependent on sample size (n), so smaller samples will naturally give a larger p-value.
He goes on to say "the margin of victory in the IMPRESS-2 study on the PDQ bother score was even smaller, with a p value of 0.0496. If a patient sneezed at the wrong time, this portion of the study would have failed."
He doesn't mention that it would've failed at the 5% significance level. At a 10% significance level, it passed by a longshot, at 2%, it did fail. Again, this could be due to too small a sample size.
I am expressing my private opinion
We are hopping two much that Xiaflex will be a silver bullet for Peyronies.
Just two things from a long list:
1. Calcified plaques and severe deformities were excluded from the trials. So just new Peyronies sufferers not with grave symptoms have a chance with it?
2. The extremely high price for Dupuytren's Contracture ($4000 without doctors fee and other expenses) will be present for Peyronies sufferers also. It will make a huge barrier for the insurance companies.
Regarding statistics, I learned some back in my university times, the difference between the drug and placebo was not so significant.
James
James
MY PERSONAL OPINION
There is NO silver bullet for peyronies. Once afflicted there is treatment but no silver bullet. Each of us is different and respond differently to different treatments.
Even with my implant I can not say peyronies does not affect me. I got the best treatment in the world for my peyronies and the damage but it was not a silver bullet. After 20+ years the the emotional and physical scar is still there.
Jackp
http://jackp-penileimplant.blogspot.com
Yeah even though there's no silver bullet, we're starting to find things that DO help (i.e. pentox), which give us a great advantage over those who had Peyronies just 10 or 20 years ago.
One thing that's reassuring is in The Street article, the Adverse Events for xiaflex injections decreased from the first study to the second study (Impress I to Impress II). For example, Penile Swelling after xiaflex injections decreased from 41.2% in the first study to 34.7% in the second, and Penile Hemorrhage rate decreased from 21.7% to 15.7%. This shows they may be optimizing the dosage, and improving the technique of the treatment and after care. They just got 3 more months before the FDA makes a decision, so maybe they can further improve it before it hits the market, if its approved.
Quote from: Craig on September 06, 2013, 10:23:47 AM
I think the only difference between Impress I and II was the timing of injections (spaced out differently)...not the injection technique or dose. I could be wrong (it's been like 4 years of this), but I think it has always been the same.
I would have loved to see this w/ the placebo control being Pentox + a saline injection...because cancer/HIV drug trials never give placebos to patients in the placebo condition. They just give the next best line of chemo/antivirals and compare the two. I would bet xiaflex would never have gotten approval if placebo patients were given pentox...since they already had quite a reduction from saline injections. I don't know if xiaflex is any better than pentox and traction given the risks involved (and basically no risk from pentox or saline injections). Naturally, they wouldn't want to study it themselves.
Quote from: james1947 on September 05, 2013, 08:49:43 PM
It's not FDA approved for calcification, so the salespeople who post on cafe pharma seem to think it will not be allowed to be used on calcified patients or *ANY* patient symptom not in the trial (so, no hourglassing, no curves over 90 degrees, etc...same restrictions). Insurance won't cover "off label use" of a $4000 (retail) drug. The docs will charge a lot of money on top of the drug cost too. Nobody knows if insurance will cover it now, but insurance covers other reconstructive procedures (which this sort of is similar to) that aren't as distressing as this.
Quote from: RoyHobbs on August 28, 2013, 03:51:47 PM
Yeah but in regards to the pictures they represented three patients out of 500 plus?? And they were mentioned in the stock analysis write ups posted a couple of days ago. I think more likely is that the FDA is trying to determine how effective the drug really is, thus the additional information submitted. But again, I'm not an expert.
Neither of the guys in those pictures had a penile fracture. They had bleeding under the skin that led to blood blisters and what seemed to be some kind of longstanding hematoma.
Has anyone else heard that Xiaflex is being delayed until December 6th due to FDA labeling issues? Heard about it from my PA yesterday - he was set to begin training for Xiaflex injection protocol and that was postponed...
Yes. That is true. Here is an article.
FDA extends PDUFA goal date for Auxilium Pharmaceuticals' sBLA for XIAFLEX (http://www.news-medical.net/news/20130828/FDA-extends-PDUFA-goal-date-for-Auxilium-Pharmaceuticals-sBLA-for-XIAFLEX.aspx)
pointedly
Yes it is not uncommon for a short delay with the FDA.
My wife and I did a Peyronies Awareness video for Auxilium/Xiaflex that is to be shown to make doctors aware of the problems that peyronies causes. It will become part of the Xiaflex training program. There are also other peyronies awareness programs in the works. Our goal is to make doctors aware of what happens when peyronies is not properly treated.
Everything is still on go once Xiaflex gets the FDA approval.
Jackp
http://jackp-penileimplant.blogspot.com
I saw my urologist yesterday and he also confirmed availability to be around the 1st of December. He believes that the best treatment approach for me is Collagenase. He said he wasn't sure about insurance coverage so I've got my fingers crossed.
Jackp, I am interested in the peyronies awareness programs. As you mentioned, I believe the more we can educate the medical community (outside of specialists) the better.
tdp1976
The fact that medical research for Peyronie's is so scant speaks volumes about how our society regards the horrific ailments that men have to deal with. It makes me angry knowing that there are a number of viable options that could very well be used to heal us from this nightmare. Yet, there is so little effort put into it by the medical community and the government because there is little to no demand by the public for enhanced treatment options for Peyronie's.
But when it comes to women's issues, the amount of money unloaded on such research is so inequitable that it makes me sick.
No matter what happens, I'm gonna spend the rest of my life making Peyronie's disease awareness one of my objectives.
I had an appointment with my doctor this morning. He told me the Xiaflex date was pushed due to packaging. He said it was not due to complications.
FDA approves first drug treatment for Peyronie's disease
Published on 06 December 2013
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SILVER SPRING, MD USA (News Release) - December 6, 2013 - The U.S. Food and Drug Administration today approved a new use for Xiaflex (collagenase clostridium histolyticum) as the first FDA-approved medicine to treat men with bothersome curvature of the penis, a condition known as Peyronie's disease.
Xiaflex is the first FDA-approved non-surgical treatment option for men with this condition, who have a plaque (lump) in the penis that results in a curvature deformity of at least 30 degrees upon erection.
Peyronie's disease is caused by scar tissue that develops under the skin of the penis. This scar tissue causes an abnormal bend during erection and can cause problems such as bothersome symptoms during intercourse.
"Today's approval expands the available treatment options for men experiencing Peyronie's disease, and enables them, in consultation with their doctor, to choose the most appropriate treatment option," said Audrey Gassman, M.D., deputy director of the Division of Bone, Reproductive and Urologic Products in the FDA's Center for Drug Evaluation and Research.
Xiaflex is a biologic medicine (made from the protein product of a living organism, collagenase clostridial histolyticum). Xiaflex was first approved by the FDA in 2010 for the treatment of Dupuytren's contracture, a progressive hand disease that can affect a person's ability to straighten and properly use their fingers. Xiaflex is believed to work for Peyronie's disease by breaking down the buildup of collagen (a structural protein in connective tissue) that causes the curvature deformity.
A treatment course for Peyronie's disease consists of a maximum of four treatment cycles. Each treatment cycle consists of two Xiaflex injection procedures (in which Xiaflex is injected directly into the collagen-containing structure of the penis) and one penile modeling procedure performed by the health care professional.
The safety and effectiveness of Xiaflex for the treatment of Peyronie's disease were established in two randomized double-blind, placebo-controlled studies in 832 men with Peyronie's disease with penile curvature deformity of at least 30 degrees. Participants were given up to four treatment cycles of Xiaflex or placebo and were then followed 52 weeks. Xiaflex treatment significantly reduced penile curvature deformity and related bothersome effects compared with placebo.
When prescribed for the treatment of Peyronie's disease, Xiaflex is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) because of the risks of serious adverse reactions, including penile fracture (rupture of one of the penile bodies within the penile shaft, also known as corporal rupture) and other serious penile injury. Xiaflex for the treatment of Peyronie's disease should be administered by a health care professional who is experienced in the treatment of male urological diseases. The REMS requires participating health care professionals to be certified within the program by enrolling and completing training in the administration of Xiaflex treatment for Peyronie's disease. The REMS also requires health care facilities to be certified within the program and ensure that Xiaflex is dispensed only for use by certified health care professionals.
The most common adverse reactions associated with use of Xiaflex for Peyronie's disease include penile hematoma, penile swelling and penile pain.
Consumers and health care professionals are encouraged to report adverse reactions from the use of Xiaflex to the FDA's MedWatch Adverse Event Reporting program at MedWatch: The FDA Safety Information and Adverse Event Reporting Program (http://www.fda.gov/MedWatch) or by calling 1-800-FDA-1088.
Xiaflex is marketed by Auxilium Pharmaceuticals, Inc., based in Chesterbrook, Pa.
For more information:
FDA Approved Drugs: Questions and Answers
NIH: Peyronie's disease
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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U.S. Food and Drug Administration (FDA)
[ NEWS RELEASE ]