FDA approves drug for severe curvature of the penis

The U.S. Food and Drug Administration on Friday approved the first drug treatment for Peyronie’s disease, a condition that results in severe and sometimes painful curvature of the penis, officials said.

The action marks a new use for the drug Xiaflex, which is already used to treat Dupuytren’s contracture, a disease of the hand that impairs a person’s ability to straighten their fingers.

Xiaflex is a bacterial enzyme -- collagenase clostridium histolyticum -- that is believed to reduce the build-up of collagen, the structural protein that makes up scar tissue.

Peyronie’s disease is the result of scar tissue forming beneath the skin of the penis and causing it to deform and bend 30 degrees or more during an erection. The condition can cause a painful erection in some men and prevent intercourse, according to doctors.

According to a statement from the drug’s maker, Auxilium Pharmaceuticals Inc. of Chesterbrook, Pa., between 65,000 and 120,000 men are diagnosed with Peyronie’s disease each year.

“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 Dr. Audrey Gassman, deputy director of the FDA’s Division of Bone, Reproductive and Urological Products.

Treatment with Xiaflex involves two injections of the drug into the penile scar tissue and a penile “modeling” procedure that involves manipulation of the penis by a healthcare provider.

Currently, the drug is available only through a restricted program under a risk evaluation and mitigation strategy, due to the potential for serious adverse reactions, such as penile fracture -- the rupture of tissue within the penis -- and other injuries. The strategy requires that healthcare practitioners and facilities be specially trained and certified to use the drug.

Other, less severe, side effects include penile bruising, swelling and pain, according to the FDA.