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First Drug Approved for Peyronie's Disease — Physician’s First Watch

Medical News |
December 9, 2013

First Drug Approved for Peyronie's Disease

By Kristin J. Kelley

The FDA has approved collagenase clostridium histolyticum (CCH, marketed as Xiaflex) as the first nonsurgical method for treating Peyronie's disease, a condition in which scar tissue develops under the skin of the penis and causes a curvature during erection, making sexual intercourse difficult.

Approval for the injectable, which works by breaking down collagen, was based on two randomized trials of some 830 men with penile curvature deformity of at least 30 degrees. Participants treated with CCH (four treatment cycles) experienced significantly reduced deformity and side effects compared with those on placebo.

The FDA is requiring a risk evaluation and mitigation strategy for those prescribing CCH for Peyronie's disease because of the risk for penile fracture and other serious adverse reactions. Penile hematoma, pain, and swelling were the most common side effects.

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