FDA Approves New Drug for Peyronie's Disease
Xioflex is first non-surgical treatment to get FDA approval
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. The drug -- first sanctioned three years ago to treat Dupuytren's contracture -- is the first medication to be approved by the agency to treat Peyronie's.
The FDA's approval of the drug Xiaflex (collagenase clostridium histolyticum) to help men with Peyronie's disease calls for a maximum of four treatment cycles. Each cycle consists of two injections and one penile remodeling procedure performed by a health care professional.
The injected drug will be available for restricted use due to significant risk for "serious penile injury," the FDA said. Both the health care professional and the associated facility must be certified for use, the agency added.
The most common side effects associated with the use of Xiaflex are swelling and pain in the penis. There is a risk for serious problems, including penile fracture, and the drug should be given by a health care professional with experience in treating male urological diseases, the FDA said
Xiaflex is marketed by Auxilium Pharmaceuticals, based in Chesterbrook, Penn.