FRIDAY, Dec. 6, 2013 (HealthDay News) -- The first drug treatment for unusual curvature of the penis has been approved by the U.S. Food and Drug Administration, the agency announced Friday.
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Men with the condition, called Peyronie's disease, have a lump in the penis that causes curvature of at least 30 degrees during an erection. The disorder, which is caused by scar tissue under the skin of the penis, can cause bothersome symptoms during sex.
Until now, surgery was the only medical option for men with the condition, according to an FDA news release.
The FDA's approval of the drug Xiaflex (collagenase clostridium histolyticum) to help men with Peyronie's disease calls for a maximum of four treatment cycles. Each cycle consists of two injections and one penile remodeling procedure performed by a health care professional.
The approval is based on two studies involving more than 800 men with Peyronie's disease. Men who received the drug had significant reductions in penile curvature and related bothersome effects, compared to those who were given an inactive placebo.
The most common side effects associated with the use of Xiaflex are swelling and pain in the penis. There is a risk for serious problems, including penile fracture, and the drug should be given by a health care professional with experience in treating male urological diseases, the FDA said.
Xiaflex was first approved by the FDA in 2010 to treat Dupuytren's contracture, a progressive hand disease that can affect a person's ability to straighten and use their fingers.
The drug is believed to work for Peyronie's disease by breaking down the buildup of collagen (a structural protein in connective tissue) that causes the deformity in the penis, the FDA explained.
The drug is marketed by Pennsylvania-based Auxilium Pharmaceuticals, Inc.
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SOURCE: U.S. Food and Drug Administration, news release, Dec. 6, 2013