When Xiaflex will be available

Previous topic - Next topic

0 Members and 1 Guest are viewing this topic.

Luciano

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


BSSS

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.

MikeSmith0

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.

Luciano

Thank you for the replies.
I will definetly contact auxilium

Luc

agent0

when do you think xiaflex will be approved and ready for the public?

Ben

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.  

agent0

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?

agent0

PEOPLE WERE SAYING IT WOULD COME OUT EARLY THIS YEAR! I NEED THIS DRUG WHATS TAKING THEM SO LONG!

agent0

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?

agent0

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?!

Worried Guy

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.   

agent0

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. =(

james1947

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
Age 71, Peyronies from Jan 2009 following penis fracture during sex. Severe ED.
Lost 2" length and a lot of girth. Late start, still VED, Cialis & Pentox helped. Prostate surgery 2014.
Got amazing support on the forum

agent0

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.

Rob

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......

agent0

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.

Rob

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.

MikeSmith0

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.   

Kempenstein

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"!

agent0

so xiaflex comes out in 2013? anyone have an estimation on what month?

Luciano

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)

newguy


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.  

ThisWontWork

Will there be any guarantees that Xiaflex will cure your ANNOYANCE? How much are you willing to pay without any guarantees ?
Pentox, CoQ-10, L-Arginine, VED, some Chinese herbs

james1947

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
Age 71, Peyronies from Jan 2009 following penis fracture during sex. Severe ED.
Lost 2" length and a lot of girth. Late start, still VED, Cialis & Pentox helped. Prostate surgery 2014.
Got amazing support on the forum

yyy

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

charlie44

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.


james1947

charlie44

Thank you for the information. Good news for many of us.

James
Age 71, Peyronies from Jan 2009 following penis fracture during sex. Severe ED.
Lost 2" length and a lot of girth. Late start, still VED, Cialis & Pentox helped. Prostate surgery 2014.
Got amazing support on the forum

charlie44

Sure, glad to help. Xiaflex is pretty much my last resort for hourglassing, since VI's did not do any good.  

agent0

yeah im really praying that itl make my nerves come back and gets rid of this hard flaccid penis.  

Luciano

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


james1947

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
Age 71, Peyronies from Jan 2009 following penis fracture during sex. Severe ED.
Lost 2" length and a lot of girth. Late start, still VED, Cialis & Pentox helped. Prostate surgery 2014.
Got amazing support on the forum

ronners

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 ...  

Luciano

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.-

James


jackp

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/



james1947

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
Age 71, Peyronies from Jan 2009 following penis fracture during sex. Severe ED.
Lost 2" length and a lot of girth. Late start, still VED, Cialis & Pentox helped. Prostate surgery 2014.
Got amazing support on the forum

ThisWontWork

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!
Pentox, CoQ-10, L-Arginine, VED, some Chinese herbs

james1947

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
Age 71, Peyronies from Jan 2009 following penis fracture during sex. Severe ED.
Lost 2" length and a lot of girth. Late start, still VED, Cialis & Pentox helped. Prostate surgery 2014.
Got amazing support on the forum

agent0

so does anyone think that xiaflex will come out by the end of this year?

james1947

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
Age 71, Peyronies from Jan 2009 following penis fracture during sex. Severe ED.
Lost 2" length and a lot of girth. Late start, still VED, Cialis & Pentox helped. Prostate surgery 2014.
Got amazing support on the forum

agent0

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?

addboy

"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
Implant: AMS
Date installed: June 2014
Doctor: Dr. Garber, Philadephia, PA

james1947

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
Age 71, Peyronies from Jan 2009 following penis fracture during sex. Severe ED.
Lost 2" length and a lot of girth. Late start, still VED, Cialis & Pentox helped. Prostate surgery 2014.
Got amazing support on the forum

agent0

omg july to december of 2013! thats like another year....F~@xiaflex hasnt given there information to the fda yet then?

how can i find out when xiaflex gives there information to the fda?

james1947

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
Age 71, Peyronies from Jan 2009 following penis fracture during sex. Severe ED.
Lost 2" length and a lot of girth. Late start, still VED, Cialis & Pentox helped. Prostate surgery 2014.
Got amazing support on the forum

agent0


agent0

when is xiaflex coming out. im so sick and tired of being numb..... :(

agent0

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?

james1947

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
Age 71, Peyronies from Jan 2009 following penis fracture during sex. Severe ED.
Lost 2" length and a lot of girth. Late start, still VED, Cialis & Pentox helped. Prostate surgery 2014.
Got amazing support on the forum

agent0