Positive Top-line Results from Both Phase III Trials of XIAFLEX

[ThisWontWork]

Auxilium Pharmaceuticals, Inc. Announces Positive Top-line Results from Both Phase III Trials of XIAFLEX® for the Potential Treatment of Peyronie's Disease

Read on: http://ir.auxilium.com/phoenix.zhtml?c=142125&p=irol-newsArticle&ID=1701869&highlight=

what is your verdict?

[james1947]

First of all I think you was faster than all of us with this news that all of us waited so much  

Second you should (maybe) change your name to ThisWillWork, but not so fast.  

The reason I am saying not so fast (to change to ThisWillWork) is that in the results as presented in the table are good, better than anything before, but they are:
Improvement (in degrees; %) XIAFLEX 17.8 (37.6%) via PLACEBO 10.1 (21.3%) IMPRESS I
Improvement (in degrees; %) XIAFLEX 16.2 (30.5%) via PLACEBO 8.5 (15.2%) IMPRESS II

So again we have something that in some cases working excellent and in some cases not so. It may be the skill of the Doctor that injects the XIAFLEX or the PLACEBO.

Encouraging that they are expecting to get FDA approval before the end of 1012.
For many of us will be the end of this ordeal

James

[Old Man]

James1947:

Not so fast for you too! The cost of Xiaflex will put it well out of the range for most guys, especially those who do not insurance that will pay. My doctor says that my insurance will not pay for Xiaflex even for Dupuytens.

So, it may not be the panacea that most think it will be not to put a damper on expectations though.

Old Man

[agent0]

for other guys that have peyronies disease do you have your scar tissue inside of the shaft of your penis or on the outside of the shaft? god i really hope this works for me cause my uro said the scar tissue is deep within the shaft of my penis. im really hoping this will work. im praying so hard to get my nerves back.

[Mathias]

Did some of you have any experience with XIAFLEX yet?

In the case of Dupuytren, it really helps. And I hope that applies for xialflex and Peyronies Disease ...

[james1947]

Mathias

Have many on the forum that were in the Xiaflex trial and have written about thy results.
You may check out the topics on "Developmental Drugs & Treatments" board related to Xiaflex.
Thread for Guys in Xiaflex Trial - Currently or Previously« 1 2 3 ... 9»
What to expect from Xiaflex
And so on...

James

[james1947]

Old Man
I understand your concerns and your point of view, but who knows? Maybe things will change regarding the insurance coverage and also we don't know yet what will be the price for a treatment. We are just guessing the subject.

If really the FDA will approve Xiaflex before the end of the year 2012 all those things will be more clear.
From yahoo, an other article stating end of 2012:
http://health.yahoo.net/news/s/nm/auxilium-penile-curvature-drug-meets-study-goal

Anyhow, those newses are not for me as my plaques are calcified and was an exclusion for calcified plaques in the trial

James

[Old Man]

James:

Recently, I inquired of my ortho hand surgeon about Xiaflex use in Dupuytren's and how much the cost would be. I may have to redo surgery on my left for the problem.

He said that one treatment of shots with Xiaflex costs him about $3,000.00. Adding the administration costs and profit for the firm would bring the total to somewhere around $4,000.00 per visit. My insurance will not pay for Xiaflex treatments, so the price puts it out of my league, etc.

The above is furnished for information in case anyone is interested in getting Xiaflex treatments. Their physicians may or may not charge these prices, etc.

Old Man

[bummedout]

Does anyone know when detailed data will be released?

[Luciano]

well there is an article in the NYTIMES 2 days ago, breaking down the info for amateur readers. They talk about the US and Australian studies.
Full article:
http://www.nytimes.com/2012/06/04/health/treatment-for-peyronies-disease-shows-promise.html

The two trials, each with more than 400 patients in the United States and Australia, were virtually identical in design and had fairly similar results.

In one trial, for instance, the average curvature for men treated with Xiaflex went from 48.8 degrees at the start of the study to 31.0 degrees a year later, an improvement of 37.6 percent. A 20 percent improvement is considered medically meaningful.

In the control group the curvature went from 49.0 degrees to 39.0 degrees, an improvement of 21.3 percent.

thats 37.6 vs 21.3 (i.e.: 16 percent ) better for xiaflex than the control group.

Now my question: I know 16 percent more reduction is better than nothing, but: how did the control group manage to get a reduction of 21.3 percent ? ? ? ?
Because as long as Xiaflex is not available, I would want to do what they did, and then, try xiaflex as soon as its on the market.

Luc

[james1947]

Luciano

I have invested time thinking about the subject when I first read the Xiaflex release form Auxilium.
In my opinion also what they inject in the placebo group (I don't know what it was) helped. Less than the Xiaflex, but helped.
Or maybe the stretching (torturing like Dracula was doing in his castle basement) had done most of the improvement and the injected material, Xiaflex or other making the rest.
Maybe VI will have the same or maybe better results if accompanied by the stretching? As no trial in the subject, maybe we will never know!

In my opinion also the capability of the doctor to inject in the exact place, exact deep was also a big factor that explain many of the differences in the results we have read on the forum.

James

[MUSICMAN]

Sorry but I don't read all the posts on the forum. It seem that some don't have much faith in the ability of Xiaflex to help with the reduction of the scar tissue related to the peyronies disease.
As I have completed the phase II trial and received the placebo I know I did not have any improvement. As I was eligible to enter the phase III trial I received the real drug this time and had some very positive results. You can read about my journey under the "Improvement" board of this forum. My feeling is that each persons condition is unique and their reaction to any type of treatment will be different. I believe that Xiaflex will help many men. I have not been put back together as if I never had peyronies and I don't think anything can make that happen, but I have been very much improved. One thing that I think is very important it the Doctor that works with you. Having the drug and knowing how to use it is a big factor. Remember there is hope and there are miracles. Musicman

[james1947]

MUSICMAN

Thank you for jumping in and your post in "Improvements" is very important to understand what to expect from Xiaflex.

My faith regarding Xiaflex is limited exactly because I think as you think:

My feeling is that each persons condition is unique and their reaction to any type of treatment will be different.

According to this statement you can judge all the other treatments (Pentox, L-Arginine, VED etc') on the same basis.

If you see the trial numbers, the placebo group improved 21.3 and the Xiaflex group 37.6. Not so drastic difference in my opinion.

From the other side, I agree with you that Xiaflex will help many of us. Just remember, the people that have calcified plaques (and I have) are excluded from the trial. Have some strong reason for that, I suppose Xiaflex in our case will help much less or not help at all.

James

[yyy]

Sorry guys

As Im not English I can't understand everything about Xiaflex results.

I'd like to know if any of the partecipants had a worsening of the fibrotic plaque, or other issues that worsen their situation

I will try Xiaflex if Im 99% sure my situation will not get worse; I never tried any kind of penile injections,I cannot risk.

Do you have some info about that??

Cheers  

[ohjb1]

To yyy - I received Xiaflex and did have serious, long term side effects. In my opinion, this was due to the Xiaflex (a powerful drug) combined with the physician's inattention to the protocol.  If you can get a copy of the informed consent form which maybe available online, you will see the potential side effects listed and should be aware that the consent form was modfied as more men had adverse effects.

I an not advising against Xiaflex, but be aware there is potential for improvement as well as damage.  Feel free to contact me at my email address if you want to discuss further.  

[james1947]

I am not against Xiaflex, as we have some testimonies on the forum that Xiaflex had excellent results.
Maybe the side effects are from physician's incompetency and not physician's inattention to the protocol?

Maybe the placebo group average improvement of 21.3 is because of competent doctors that injected the placebo liquid in the correct place and performed the correct protocol regarding stretching?

Maybe if we will see the improvement of the placebo group and the improvement of the Xiaflex group doctors related we will find out that if the placebo group had higher than everage improvement the Xiaflex group had much better improvement than the everage of 37.6 also?

More I am thinking about this research, more it seems to me that the results are doctors competency related. Just my opinion.

James

[ohjb1]

to james - I do not disagree with anything you wrote. Think it is entirely proper to equate inattention to protocol to incompetency.    

[yyy]

does anyone know the name of the doctors invloved in Xiaflex trials?

[bummedout]

Ya know, I'd really like to believe that Xiaflex is the answer, but it just seems like it's more of a shareholder drug to me.  They've invested too much in it already for it to fail.  I'm really not impressed with their baseline data, and the side effects are just f'~c<+d.  This drug seems dangerous, and it seems like it could make things worse, especially with people like me who have plaques located in difficult spots.  I didn't want to believe it but it looks like I'll never please a woman sexually again.  At my young age of 32, it really sucks to think that I'm going to be alone the rest of my life.  I hate to admit it, but suicide has been on my mind.  Sorry to bum everyone out.  I'm just venting.

[rd]

I have to agree with bummedout. I would like a answer to this horrific condition but I don't think Xiaflex is it. I don't want to bring anyone down but I'm not sure what all the excitement is about for this treatment. I don't see how the results are top-line when the results they refer to  as top-line weren't  far off from the people not getting the drug. To me this seem to be in the category of VI where some have improvements some don't and some get worse, basically the same out comes I have read about with VI and the only difference being that this has a backing because lots of money was been put into it. I think I'll save my excitement for the day where they can not just improve the condition but actually get rid of it.  

[james1947]

As I have stated in my previous post, some of the forum members had very good results.
I will say again, have no big difference between the average improvement in the placebo and Xiaflex group.

In my opinion, the good results in both groups are results of competent doctors that know how to inject and follow the protocol and not the substance that is injected.
Unfortunately we will never know who are the competent doctors!

bummedout
I know that in your age is very difficult to accept the situation and really you should not accept, bu this disease affected many older people in a very devastated way.
Personally at the age of 64, this disease devastated my life in a way that I will never be even close to what was before.

You are too young for your statement:

I hate to admit it, but suicide has been on my mind

Do everything you can to go out from this mood!
I was also very depressed (never suicidal), what helped me most is being active on this forum.

Have solution to make you to be like before the Peyronies, some solutions even better. Some on the forum are approaching the Peyronies like me, giving a chance to oral remedies & VED before proceeding to surgery (including implant) some are not and going to surgery after a short time. Most, including on other forums also regarding ED are very pleased with the results of the surgeries.

James