Based on the feedback I receive at this site, there is considerable interest in Xiaflex as a non-surgical treatment for Peyronies Disease (PD).
The Xiaflex clinical trials are completed and Auxilium Pharmaceuticals, Inc. has submitted their findings to the Federal Drug Administration (FDA) for review and on various website and forums have often been misleading and at most, only provide a minimal amount of useful information. The reason is that this more recent material relates to phase III/open source studies of Xiaflex and they are press releases. The material in these press releases are summarized and repeated, mostly on financial websites concerning whether or not Auxilium stock is a good buy. Only Auxilium and the FDA have the data necessary to properly evaluate the findings of the phase III and open source Xiaflex trials.
The latest Xiaflex Peyronies Disease study with reliable and detailed information available to the public is from an earlier phase IIb clinical trial. In the Summer 2010 edition of this website, I wrote about these study results based on press releases from Auxilium. If you are considering, taking Xiaflex for your Peyronies, I urge you to start by reading that article. Click Here . You can also obtain additional information on Xiaflex by typing it in the search box of this site.
More detailed findings from the phase IIb trial have been published in the June 2012, Journal of Urology article and findings and protocol information have been posted on the U.S. Government's clinical trials website. Some of this information will be repetitive when compared with the Summer 2010 article, but there is additional, valuable information to be found.
I was in this phase IIb study where I received a placebo and also participated in the open source clinical trial where I did receive the Xiaflex treatment. This open source trial ran essentially concurrently with the last phase III Xiaflex trial.
In order to decrease the level of anxiety we all feel when undergoing medical testing and particularly, penile injections, I will inform my readers what to expect during their screening and Xiaflex treatment based on the current protocol. Unfortunately, I will also discuss what can go very wrong and how to decrease the odds of experiencing a serious adverse event or events.
Summary of Phase IIb of the Xiaflex study
total of 147 participants
mean age was 57 years
mean curvature was 54 degrees (range 33-89)
majority of men reported some degree of erectile dysfunction
modeling is defined as gently stretching the placid penis in the opposite direction of the curvature and holding it in that position for 30 seconds before allowing the penis to return to the non-modeled state for 39 seconds. This procedure was repeated 3 times 24 to 72 hours after the 2nd injection at each treatment cycle in the phase IIb Xiaflex clinical trial. Men in the modeling group were also instructed to perform this procedure at home.
74 men were in the modeling group - 54 received Xiaflex and 20 received a placebo
73 men were in the non-modeling group - 57 received Xiaflex and 16 received a placebo
each cycle of injections consisted of 2 injections with an interval of 24 to 72 hours
this regimen was repeated after 6 weeks for a period of up to 3 treatment cycles
In the last edition of this site, I reviewed the use of coenzyme Q10 for the treatment of Peyronies. If you want to read the entire article on this topic Click
There is a man who had Peyronies and through treatment was able to become sexually functional again. He has started a website and I recommend you also visit his site. Click Here is another informational Peyronies site that I would recommend Click