Peyronie's Disease aka curved penis, erectile dysfunction,impotence

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Summer 2010
Edition

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dedicated solely to news about Peyronie's Disease

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XIAFLEX FOR PEYRONIES PHASE IIb STUDY RESULTS

MIXED RESULTS...UNANSWERED QUESTIONS

In 12/2009, Auxilium Pharmaceuticals released results of their Phase IIb
clinical trial for the use of Xiaflex for Peyronies Disease (PD) and stated
that the results showed that Xiaflex demonstrated a sustained benefit
versus a placebo. Their researcher concluded that Xiaflex offered a
statistically significant improvement in the reduction of penile curvature
and was an enormous advantage for men with PD. In reviewing the
available material, there are a number of unanswered questions and
issues about the effectiveness of Xiaflex still outstanding that are
discussed below.

First, some background information:

For readers not familiar with Xiaflex, Click Here for a detailed
history of the discovery and development of this drug

I hoped to write a completely favorable article about Xiaflex.
However, I wrote to Auxilium Pharmaceuticals with questions
about their study. Although I was promised answers, none were
forthcoming

This clinical trial included a relatively small number of men and
this may have some bearing on the validity of the outcome.
However, I have no choice to work with the data that is available.
A total of 145 men were enrolled in the trial nationwide at 12
clinical sites. One hundred and nine (109) received penile
injections of Xiaflex into the Peyronies plaque and they were
divided into 2 groups; half performed modeling and the other half
did not. Thirty-six (36) men received a placebo injection. Study
participants were followed over a 36 week period. Further testing
should begin later this year in a larger Phase III clinical trial

For the purpose of this study, "modeling" means bending and
stretching the penis for 60 seconds, twice a day. Note that in
Auxilium's financial report they erroneously report that modeling
refers to massaging the penis in order to increase the affect of
Xiaflex

The goal of the study was to demonstrate that Xiaflex injections
would reduce penile curvature by 25%. This does not mean a 25
degree reduction. For example, if a man had a 60 degree
curvature, success would be defined as a curvature decrease of
15 degrees

Another goal was the company's Patient Reported Outcomes (PRO)
questionnaire that measured responses that addressed penile
pain, Peyronies Disease bother, intercourse discomfort and
intercourse restraint

A 100% Cure...In 10 Years