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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
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
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