The FDA has approved a new indication for Xiaflex (collagenase clostridium histolyticum; Auxilium) for the treatment of Peyronie’s disease, a curvature deformity of the penis due to the presence of a plaque. Xiaflex is the first FDA-approved non-surgical treatment for men with this condition.

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The safety and efficacy of Xiaflex for the treatment of Peyronie’s disease were established in two randomized double-blind, placebo-controlled studies in men with Peyronie’s disease (n=832) with penile curvature deformity of >30 degrees. Treatment with Xiaflex significantly reduced penile curvature deformity and related bothersome effects compared to placebo.

A treatment course for Peyronie’s disease consists of a maximum of four treatment cycles. Each treatment cycle consists of two Xiaflex injection procedures (in which Xiaflex is injected directly into the collagen-containing structure of the penis) and one penile modeling procedure performed by the health care professional.

When prescribed for Peyronie’s disease, Xiaflex is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) due to the risks of serious adverse reactions, including penile fracture and other serious penile injury. 

Xiaflex was approved in 2010 for the treatment of adult Dupuytren’s contracture patients with a palpable cord.   

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