FDA approves Xiaflex for Peyronie’s disease


The Food and Drug Administration has approved the biologic drug Xiaflex (collagenase clostridium histolyticum) for Peyronie’s disease, making it the first FDA-approved medicine for men with the disease.

Xiaflex, originally approved in 2010 to treat the hand deformity Dupuytren’s contracture, is the first available nonsurgical treatment option for Peyronie’s disease, a condition in which scar tissue develops under the skin of the penis to form a lump. This scar tissue causes an abnormal bend during erection that may cause discomfort during intercourse.

"Xiaflex is believed to work for Peyronie’s disease by breaking down the buildup of collagen that causes the curvature deformity," the FDA said in a statement Dec. 6.

A treatment cycle with Xiaflex consists of two injections directly into the collagen-containing part of the penis and one penile modeling procedure. The patient may undergo a maximum of four treatment cycles.

Xiaflex was studied in two trials of a total of 832 men with Peyronie’s disease and a penile curvature deformity of at least 30 degrees. Patients received either placebo or up to four Xiaflex treatment cycles and were followed over 52 weeks.

The FDA reported that Xiaflex "significantly reduced penile curvature deformity and related bothersome effects" compared with placebo, but warned of possible adverse side effects of the drug, such as penile fracture, hematoma, swelling, and pain.

Because of the risk for adverse reactions, Xiaflex for the treatment of Peyronie’s disease is available only through a restricted program under a Risk Evaluation and Mitigation Strategy. The program requires participating doctors to undergo training and certification in the administration of the drug.

Adverse reactions from the use of Xiaflex should be reported to the FDA’s MedWatch Adverse Event Reporting Program online or by calling 800-FDA-1088.

Xiaflex is marketed by Auxilium Pharmaceuticals.

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