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When Xiaflex will be available

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Hawk

Lets be cautious about referring to Xiaflex as a cure.  It is a treatment with mixed results.
Prostatectomy 2004, radiation 2009, currently 70 yrs old
After pills, injections, VED - Dr Eid, Titan 22cm implant 8/7/18
[url=http://www.peyroniesforum.net/index.php/topic,872.0.html]Hawk - Updated 10/27/18 - Peyronies Society Forums[/url]

james1947

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
Age 71, Peyronies from Jan 2009 following penis fracture during sex. Severe Erectile Dysfunction.
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

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?



agent0

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.

james1947

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

ComeBacKid

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
[url=http://www.peyroniesforum.net/index.php?topic=899.0]My History[/url]

MattFoley

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.


Got Testosterone?

LWillisjr

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".  ;-)
Developed peyronies 2007 - 70 degree dorsal
Traction/MEDs/Injections/Surgery 2008
66y/o  14 years Peyronies free
[URL="[url="http://www.peyroniesforum.net/index.php/topic,895.0.html"]http://www.peyroniesforum.net/index.php/topic,895.0.html[/url]"]My History

BrooksBro

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


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://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.

BrooksBro

June 4 2012 Top Line Phase III results

Shows Q3-Q4 2013 potential FEA approval of Xiaflex for Peyronie's disease and launch

Iceman

so when will this treatment be ready for actual use......

BrooksBro


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......

Iceman

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!

james1947

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

Iceman

does anyone know if there will be clinical trials of xiaflex in Australia?? - i would like to try

james1947

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

BrooksBro

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


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

james1947

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

lukewill

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

james1947

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

BrooksBro

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.

lukewill

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

james1947

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

Iceman

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???

james1947

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

addboy

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/

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.

charlie44

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.

funnyfarm

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.   
When you are in tune with the unknown, the known is peaceful.

MattFoley

We're looking at FDA action by September 6, 2013.

I really hate the FDA.
Got Testosterone?

charlie44

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.

Iceman

so does this mean that if you have had Peyronies Disease for many years, then xiaflex wont work??

LWillisjr

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.
Developed peyronies 2007 - 70 degree dorsal
Traction/MEDs/Injections/Surgery 2008
66y/o  14 years Peyronies free
[URL="[url="http://www.peyroniesforum.net/index.php/topic,895.0.html"]http://www.peyroniesforum.net/index.php/topic,895.0.html[/url]"]My History

Iceman

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.

watcher

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?

RoyHobbs

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.

RoyHobbs

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

Norm

Treatment for Painful Curved Penis Shows Promise - Erectile Dysfunction Center - Everyday Health

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.
Plication Surgery Dec. 2013. Straight Again!

betseyagopian

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?".

MikeSmith0

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 - 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

metoo2

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

jackp

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
[url=http://www.peyroniesforum.net/index.php/topic,890.0.html]My History[/url]

ThisWontWork

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.

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

MattFoley

Got Testosterone?

ThisWontWork

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

damian


Skjaldborg

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

inkhorn

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

RoyHobbs

Here's another link to a stock analysis that believes it will be approved. It's a mobile link, FYI.

Seeking Alpha

james1947

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

RoyHobbs