FDA approves Xiaflex to treat Peyronie’s disease

The U.S. Food and Drug Administration today approved a new use for Xiaflex (collagenase clostridium histolyticum) as the first FDA-approved medicine to treat men with bothersome curvature of the penis, a condition known as Peyronie’s disease.

Xiaflex is the first FDA-approved non-surgical treatment option for men with this condition, who have a plaque (lump) in the penis that results in a curvature deformity of at least 30 degrees upon erection.

“Today’s approval expands the available treatment options for men experiencing Peyronie’s disease, and enables them, in consultation with their doctor, to choose the most appropriate treatment option,” said Audrey Gassman, M.D., deputy director of the Division of Bone, Reproductive and Urologic Products in the FDA’s Center for Drug Evaluation and Research.

Xiaflex is a biologic medicine (made from the protein product of a living organism, collagenase clostridial histolyticum). Xiaflex was first approved by the FDA in 2010 for the treatment of Dupuytren’s contracture, a progressive hand disease that can affect a person’s ability to straighten and properly use their fingers. Xiaflex is believed to work for Peyronie’s disease by breaking down the buildup of collagen (a structural protein in connective tissue) that causes the curvature deformity.

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.

What is Peyronie’s disease?

It’s an abnormal bend in the penis that occurs during erection. In Peyronie’s disease, fibrous scar tissue develops under the skin of the penis. The cause of this fibrous tissue is not known.

Fracture of the penis (injury during intercourse) can lead to this condition. Patients have a higher risk after surgery or radiation treatment for prostate cancer.

Peyronie’s disease is uncommon and affects men ages 40 – 60 and older.

During erection, there may be a bend in the penis, which usually begins at the area where you feel the scar tissue or hardening, a narrowing of the penis, pain, problems with penetration or pain during intercourse and a shortening of the penis.

The safety and effectiveness of Xiaflex for the treatment of Peyronie’s disease were established in two randomized double-blind, placebo-controlled studies in 832 men with Peyronie’s disease with penile curvature deformity of at least 30 degrees. Participants were given up to four treatment cycles of Xiaflex or placebo and were then followed 52 weeks. Xiaflex treatment significantly reduced penile curvature deformity and related bothersome effects compared with placebo.

The most common adverse reactions associated with use of Xiaflex for Peyronie’s disease include penile hematoma, penile swelling and penile pain.

Xiaflex is marketed by Auxilium Pharmaceuticals, Inc., based in Chesterbrook, Pa.

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