FDA approves Xiaflex for Peyronie’s disease

FDA approved a new use for collagenase clostridium histolyticum (Xiaflex, Auxilium Pharmaceuticals) 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.

“The FDA approval of Xiaflex for the treatment of Peyronie’s disease offers a new therapeutic option for men to consider who may otherwise not receive adequate treatment either due to under-reporting or potential lack of accurate diagnosis,” said Formulary advisor Abimbola Farinde, PharmD, MS, who serves on the faculty at Columbia Southern University, Orange Beach, Ala.

Peyronie’s disease is caused by scar tissue that develops under the skin of the penis. This scar tissue causes an abnormal bend during erection and can cause problems such as bothersome symptoms during intercourse.

Xiaflex was first FDA approved 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 that causes the curvature deformity.

A treatment course for Peyronie’s disease consists of a maximum of 4 treatment cycles. Each treatment cycle consists of 2 Xiaflex injection procedures (in which Xiaflex is injected directly into the collagen-containing structure of the penis) and 1 penile modeling procedure performed by the healthcare professional.

The safety and effectiveness of Xiaflex for the treatment of Peyronie’s disease were established in 2 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 4 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.

For treatment of Peyronie’s disease, Xiaflex is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) because of the risks of serious adverse reactions, including penile fracture (rupture of 1 of the penile bodies within the penile shaft, also known as corporal rupture) and other serious penile injury. Xiaflex for the treatment of Peyronie’s disease should be administered by a healthcare professional who is experienced in the treatment of male urological diseases. The REMS requires participating healthcare professionals to be certified within the program by enrolling and completing training in the administration of Xiaflex treatment for Peyronie’s disease. The REMS also requires healthcare facilities to be certified within the program and ensure that Xiaflex is dispensed only for use by certified healthcare professionals.

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

Consumers and healthcare professionals are encouraged to report adverse reactions from the use of Xiaflex to FDA’s MedWatch Adverse Event Reporting program or by calling (800) FDA-1088.