Auxilium completes enrollment in Phase IIb Peyronie’s trial

In accordance with the study design, all enrolled patients have received their first injection of either Xiaflex or placebo. Due to the high level of interest from patients and physicians, the company exceeded its enrollment target of 120 patients.

The Phase IIb study is a randomized, double-blind, placebo-controlled study that is designed to assess the safety and efficacy of Xiaflex, when administered two times a week every six weeks for up to three treatment cycles, in subjects with Peyronie’s disease. The study is being conducted at 12 sites throughout the US, and patients will be monitored for 36 weeks following the first injection.

The trial is designed to complete the validation of the company’s Peyronie’s patient reported outcome (PRO) questionnaire, which will measure several domains of patients’ sexual quality of life, over a 36 week period. The four domains measured by the PRO are penile pain, Peyronie’s disease bother, intercourse discomfort and intercourse constraint. After validation, the company plans to use the PRO for its Phase III Peyronie’s disease trials, where it is intended to be used as the primary endpoint.

Armando Anido, CEO and president of Auxilium, said: We are quite pleased to achieve this important development milestone in Peyronie’s disease and advance what can potentially be a second indication for Xiaflex. We continue to believe that we will report top line results from the study in the fourth quarter of 2009.