Peyronie’s agent meets phase III study endpoints

Data from phase III studies of collagenase clostridium histolyticum (CCH [XIAFLEX]) showed that the agent met primary endpoints related to Peyronie’s disease (PD) curvature and symptoms, and that it is effective and safe in certain subgroups of men with PD, according to Auxilium Pharmaceuticals, Inc.

Study data were presented at the Sexual Medicine Society of North America annual fall scientific meeting in New Orleans.

Highlights from the phase III IMPRESS (The Investigation for Maximal Peyronie’s Reduction Efficacy and Safety Studies) trials included:

• An open-label baseline analysis from IMPRESS 3 showed a mean penile curvature deformity (PCD) of 53.0 degrees and a mean PD symptom bother score of 7.3. In this study, both co-primary endpoints of change in PCD and PD symptom bother were met with statistical significance compared to baseline. The mean percent change in PCD was 34.4% and the mean change in PD symptom bother score was 3.3 from baseline.

• In a study examining different subgroups of men treated with CCH based on their prior PD treatment, erectile dysfunction scores, and prostatectomy history, the clinical outcomes related to PCD and PD bother did not vary among these subgroups.

• A comparison of adverse events related to CCH injections among men with a curvature ≥30 degrees versus <30 degrees concluded that there was no clinically meaningful difference.

"We are pleased to share these results with the medical community and remain dedicated to an ongoing examination of XIAFLEX for the potential treatment of Peyronie's disease," said James Tursi, MD, of Auxilium.

The company's supplemental biologics license application for the drug’s use in the treatment of PD is currently under review at the FDA. The Prescription Drug User Fee Act review date is this Friday, Dec. 6.

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