FDA Approves First Non-surgical Treatment for Peyronie's Disease

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FDA Approves First Non-surgical Treatment for Peyronie's Disease

 

The US Food and Drug Administration (FDA) cleared Auxilium Pharmaceutical's Xiaflex product to treat Peyronie's disease, a condition that causes painful curvature of the penis. Peyronie's is thought to affect up to 5 per cent of the male population and occurs as a result of chronic inflammation of soft tissues in the penis, leading to the formation of scars or plaques. The plaques can cause pain and curvature of the penis on erection and may make intercourse difficult.

 

Xiaflex (collagenase clostridium histolyticum) is the first non-surgical treatment to be approved for Peyronie's disease and is indicated for men who have a palpable plaque that results in a curvature deformity of at least 30 degrees upon erection, according to the FDA.

 

The product is already approved in the US to treat Dupuytren's contracture, a progressive hand disease that can affect a person's ability to straighten and properly use their fingers, and is thought to work by breaking down collagen deposits that form in connective tissue. There seems to be some crossover between the two indications - around 30 per cent of men with Peyronie's also develop connective tissue problems in other parts of the body, including the hand, and it is though there may be some genetic component to the disease.

 

See the full article on PMLiVE.com.

See the official FDA Announcement on FDA.gov.

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Here's the WebMD article about the drug approval:

 

[big]Xiaflex is first non-surgical treatment to get FDA approval[/big]

WebMD News from HealthDay

 

By Scott Roberts - HealthDay Reporter

 

FRIDAY, Dec. 6, 2013 (HealthDay News) -- Xiaflex (collagenase clostridium histolyticum) has been approved by the U.S. Food and Drug Administration to treat Peyronie's disease, an uncomfortable curvature of the penis.

 

The drug -- first sanctioned three years ago to treat a hand deformity called Dupuytren's contracture -- is the first medication to be approved by the agency to treat Peyronie's.

 

The condition occurs when scar tissue forms under the skin, causing a curvature of the penis of at least 30 degrees, the FDA said Friday in a news release. This can lead to problems including "bothersome symptoms" during intercourse, the agency said.

 

The injected drug will be available for restricted use due to significant risk for "serious penile injury," the FDA said. Both the healthcare professional and the associated facility must be certified for use, the agency added.

 

Potential side effects of the drug and a related non-surgical procedure include bruising, swelling and pain, the FDA said.

 

Xiaflex is marketed by Auxilium Pharmaceuticals, based in Chesterbrook, Pennsylvania.