Auxilium Pharmaceuticals, Inc. (AUXL) revealed top-line efficacy and safety results for the phase IIb clinical trial for XIAFLEX in the treatment of Peyronie's disease. The company noted that the phase IIb study was designed to measure efficacy endpoints of improvement in penile curvature and improvement in patients' sexual quality of life using the Company's Peyronie's disease Patient Reported Outcome, or PRO, questionnaire.
According to the company, overall, XIAFLEX demonstrated a statistically significant change compared to placebo at 36 weeks in both improvement in penile curvature and the PRO Peyronie's disease bother domain.
The company also noted that XIAFLEX was well-tolerated and the most common treatment related adverse events in the phase IIb study were consistent with adverse events reported in previous Peyronie's disease trials with XIAFLEX, which included injection site bruising, edema and pain.
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