The sBLA submission is based on data from the clinical studies known by the acronym IMPRESS – The I nvestigation for M aximal P eyronie's R eduction E fficacy and S afety S tudies – and other controlled and uncontrolled clinical studies, in which over 1,000 Peyronie's disease patients were enrolled and received over 7,400 injections of XIAFLEX.In the two phase III double-blind placebo-controlled IMPRESS studies, XIAFLEX demonstrated statistically significant improvement in the co-primary endpoints of penile curvature deformity and patient-reported bother versus placebo. In IMPRESS I at 52 weeks, the co-primary endpoints met statistical significance with a 37.6% mean reduction in penile curvature deformity for XIAFLEX subjects (p=0.0005) and a 3.3 point improvement in the Peyronie's Disease Questionnaire (PDQ) bother domain for XIAFLEX subjects (p=0.0451). In IMPRESS II at 52 weeks, the co-primary endpoints met statistical significance with a 30.5% mean improvement in penile curvature deformity for XIAFLEX subjects (p=0.0059) and a 2.4 point improvement in the PDQ bother domain for XIAFLEX subjects (p=0.0496). XIAFLEX was generally well-tolerated. The most common treatment related adverse events reported in the phase III studies were local to the treatment site and consistent with adverse events reported in previous PD trials with XIAFLEX, which included injection site hematoma, pain and swelling. Serious adverse events included corporal rupture (penile fracture) in 3 subjects in the placebo controlled studies.
Auxilium Pharmaceuticals, Inc. Submits Supplemental Biologics License Application To The FDA For XIAFLEX® For The Treatment Of Peyronie's Disease
Check Out Our Best Services for Investors
Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.
- Model portfolio
- Stocks trading below $10
- Intraday trade alerts
David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
Every recommendation goes through 3 layers of intense scrutinyquantitative, fundamental and technical analysisto maximize profit potential and minimize risk.
More than 30 investing pros with skin in the game give you actionable insight and investment ideas.