FDA Approvals New Drug Approved for Peyronie's Disease -- Scott Roberts

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FRIDAY, Dec. 6, 2013 (HealthDay News) -- Xiaflex (collagenase clostridium histolyticum) has been approved by the U.S. Food and Drug Administration to treat Peyronie's disease, an uncomfortable curvature of the penis.

The drug -- first sanctioned three years ago to treat a hand deformity called Dupuytren's contracture -- is the first medication to be approved by the agency to treat Peyronie's.

The condition occurs when scar tissue forms under the skin, causing a curvature of the penis of at least 30 degrees, the FDA said Friday in a news release. This can lead to problems including "bothersome symptoms" during intercourse, the agency said.

The injected drug will be available for restricted use due to significant risk for "serious penile injury," the FDA said. Both the healthcare professional and the associated facility must be certified for use, the agency added.

Potential side effects of the drug and a related non-surgical procedure include bruising, swelling and pain, the FDA said.

Xiaflex is marketed by Auxilium Pharmaceuticals, based in Chesterbrook, Penn.

More information

The FDA has more about this approval.

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