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New Australian drug approvals subject to budget cuts

January 29, 2016

The trials' co-primary endpoints are the mean percent improvement from baseline in penile curvature compared to placebo and the mean change from baseline in the Peyronie's disease bother domain of the Peyronie's Disease Questionnaire (PDQ) compared to placebo.  The PDQ is a proprietary questionnaire that the Company developed with the FDA following our phase IIb studies as a valid tool for measuring Peyronie's disease bother.  The PDQ also measures severity of psychological and physical symptoms of Peyronie's disease and penile pain.  Safety measurements include adverse event monitoring, immunogenicity testing and clinical labs.

"We are encouraged by the clinical profile of XIAFLEX, which emerged from our earlier phase II and IIb clinical trials in Peyronie's disease," said James P. Tursi, M.D., Auxilium's Vice President of Clinical Research & Development.  "We believe that our phase III double-blind studies with XIAFLEX in Peyronie's disease should provide pivotal evidence that XIAFLEX is well-tolerated and produces clinically and statistically significant reductions in both penile curvature and disease bother."  

SOURCE Auxilium Pharmaceuticals, Inc.