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Welcome to Dr. Landon Trost - Directly answering member questions in the "Medical Professionals" section below the Treatment boards. https://www.peyroniesforum.net/index.php/topic,16512.0.html

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Author Topic: When Xiaflex will be available  (Read 48874 times)

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agent0

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Re: XIAFLEX Approval Delayed
« Reply #100 on: August 28, 2013, 01:59:06 PM »

Wtf are you serious? What does this mean? Is something wrong?
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metoo2

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Re: XIAFLEX Approval Delayed
« Reply #101 on: August 28, 2013, 02:35:40 PM »

Looks like it has been delayed:

Auxilium Receives Notification of XIAFLEX(R) PDUFA Extension - WSJ.com

Not sure what this means. The FDA needs more time to look at the results.
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RoyHobbs

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Re: XIAFLEX Approval Delayed
« Reply #102 on: August 28, 2013, 03:16:07 PM »

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.
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GS

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Re: XIAFLEX Approval Delayed
« Reply #103 on: August 28, 2013, 03:45:14 PM »

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.
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RoyHobbs

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Re: XIAFLEX Approval Delayed
« Reply #104 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.
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Old Man

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Re: XIAFLEX Approval Delayed
« Reply #105 on: August 28, 2013, 04:11:21 PM »

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
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Age 92. Peyronies Disease at age 24, Peyronies Disease after
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Three more stents in 2016. Hiatal hernia surgery 2017 with 1/3 stomach reduction. Many other surgeries too.

bummedout

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james1947

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Re: When Xiaflex will be available
« Reply #107 on: September 05, 2013, 05:45:49 AM »

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
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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

Craig

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Re: The Best Analysis of Auxilium FDA approval chances
« Reply #108 on: September 05, 2013, 07:42:32 AM »

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

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.
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james1947

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Re: When Xiaflex will be available
« Reply #109 on: September 05, 2013, 08:49:43 PM »

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
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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

jackp

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Re: When Xiaflex will be available
« Reply #110 on: September 05, 2013, 10:04:44 PM »

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
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Craig

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Re: When Xiaflex will be available
« Reply #111 on: September 06, 2013, 10:23:47 AM »

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.
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MikeSmith0

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Re: When Xiaflex will be available
« Reply #112 on: September 06, 2013, 08:45:46 PM »



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.
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MikeSmith0

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Re: When Xiaflex will be available
« Reply #113 on: September 06, 2013, 08:52:53 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. 
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MikeSmith0

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Re: XIAFLEX Approval Delayed
« Reply #114 on: September 06, 2013, 08:55:11 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.
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pointedly

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Re: When Xiaflex will be available
« Reply #115 on: September 14, 2013, 11:22:43 AM »

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...
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Litani

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Re: When Xiaflex will be available
« Reply #116 on: September 14, 2013, 11:24:50 AM »

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jackp

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Re: When Xiaflex will be available
« Reply #117 on: September 14, 2013, 04:34:17 PM »

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
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tdp1976

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Re: When Xiaflex will be available
« Reply #118 on: September 17, 2013, 02:40:01 PM »

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
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MattFoley

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Re: When Xiaflex will be available
« Reply #119 on: September 17, 2013, 05:51:48 PM »

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.

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Litani

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Re: When Xiaflex will be available
« Reply #120 on: September 17, 2013, 06:12:07 PM »

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.
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positiveoutlook

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FDA approves first drug treatment for Peyronie’s disease
« Reply #121 on: February 25, 2014, 11:55:22 PM »


FDA approves first drug treatment for Peyronie’s disease
Published on 06 December 2013

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inShare

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 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.
###

U.S. Food and Drug Administration (FDA)

 

[ NEWS RELEASE ]

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