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FDA approves first drug treatment for abnormal curvature of the penis

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Xiaflex, a biologic medicine (made from the protein product of a living organism, collagenase clostridial histolyticum) originaaly used to treat Dupuytren’s contracture, a progressive hand disease that can affect a person’s ability to straighten and properly use their fingers, has now been approved to treat curvature of the penis as well.
Known as Peyronie’s disease the condition is results from a build up of scar tissue that develops under the skin of the penis, causong it to bend by (at least) 30 degrees during erection. It is believed that Xiaflex serves to correct this problem by breaking down the buildup of collagen within the organ. that causes the curvature deformity.

“This is the first non-surgical treatment available for men experiencing Peyronie’s disease, and enables them, in consultation with their doctor, to choose the most appropriate course of action in curing it,” said Audrey Gassman, M.D., deputy director of the Division of Bone, Reproductive and Urologic Products in the FDA’s Center for Drug Evaluation and Research.

The actual treatment course for Peyronie’s disease consists of a maximum of four cycles each consisting of two Xiaflex injection (made directly into the collagen-containing structure of the penis) and one penile modeling procedure performed by the health care professional.
The most common adverse reactions reported included penile hematoma, swelling of the penis, and penile pain.

It should be noted that Xiaflex treatments are only available through a “ restricted program under a Risk Evaluation and Mitigation Strategy (REMS)” due to risks of serious adverse reactions, including penile fracture (rupture of one of the penile bodies within the penile shaft . According to the FDA, REMS health care facilities must be certified within the program and guarantee that the drug is “dispensed only for use by certified health care professionals.”

For more information, readers can contact the FDA at 888-INFO-FDA



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