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FDA Approves Expensive Drug Xiaflex To Treat Penis Curvature

The Food and Drug Administration has approved a drug to treat severe and even painful curvature of the penis, a condition called Peyronie’s disease.

Xiaflex, which costs $3,300 per injection, is already used to treat Dupuytren’s contracture, a condition of the hand in which the fingers can’t be straightened.

Pyronie’s disease is the result of scar tissue forming beneath the skin of the penis. When erect the penis will bend 30 degrees or more, leading to painful erections and intercourse.

Between 65,000 and 120,000 men are diagnosed with Peyronie’s annually.

“It’s a soul-destroying disease,” Stan Hardin, a plumber in Colorado Springs, who started the Association of Peyronie’s Disease Advocates, told the New York Times.

Xiaflex is a bacterial enzyme derived from gangrene causing bacterium that reduces the build-up of collagen in the penis.

Treatment for Peyronie’s includes eight injection of Xiaflex into the penis, done once every six weeks.

The full course of treatment would cost at least $26,000, the Times reports.

Drug maker Auxilium Pharmaceuticals Inc., of Chesterbrook, Pa., says they are currently setting up a program to give patients insurance reimbursement. They also began a campaign to raise awareness of the disease.

"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.

Sources: Los Angeles Times, New York Times


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