Auxilium announced completion of enrollment for its Phase 3 double-blind, placebo-controlled study of Xiaflex (collagenase clostridium histolyticum) for the treatment of Peyronie’s Disease. The coprimary endpoints are the mean percent improvement from baseline in penile curvature compared with placebo and the mean change from baseline in the Peyronie’s disease bother domain of the Peyronie’s Disease Questionnaire (PDQ) compared with placebo. The PDQ is a proprietary questionnaire that Auxilium developed in conjunction with the FDA following its Phase 2b 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. In accordance with the study design, all enrolled patients will have received their first injection of either Xiaflex or placebo by the end of March 2011.
Xiaflex contains a mixture of collagenase proteins that hydrolyze collagen in its native triple helical conformation under physiological conditions, resulting in lysis of collagen deposits. Xiaflex is currently indicated for the treatment of adult patients with Dupuytren’s contracture with a palpable cord.
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