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FDA Approves Treatment for Curved Penis

Update Date: Dec 07, 2013 11:47 AM EST

The U.S Food and Drug Administration (FDA) has approved a drug for treating Peyronie's disease, which occurs when the penis curves during erection and causes a lot of pain. According to the Peyronie's Association, the condition affects a little over nine percent of men, which is about one out of 11. The condition can greatly affect men's mental health and now, a new treatment option might be able to help these men.

"It's a soul-destroying disease," said Stan Hardin, a plumber in Colorado Springs, who started the Association of Peyronie's Disease Advocates after being diagnosed 12 years ago according to the New York Times.

The drug that won approval is called Xiaflex, which is manufactured by Auxilium Pharmaceuticals. The drug was approved after the results from two clinical trials including 832 men proved to be successful. Xiafex treatment includes a total of eight injections into the penis done six weeks apart. The drug is an enzyme that helps breakdown collagen, which causes the condition. Peyronie's disease is caused by a buildup of plaque underneath the skin of the penis and collagen is the main component of the plaque buildup.

Even though the drug is approved, administration of it will require doctors to become certified after being specially trained. The drug costs $3,300 per injection, which totals to around $26,000.

"Patients with Peyronie's have been very eager for an effective minimally invasive therapy and we believe that the sBLA approval represents tremendous advance in the treatment for this physically and psychologically devastating disease," said Thomas L. Wegman, President of BioSpecifics. "We expect to continue the XIAFLEX market expansion as we move forward in our own development of the product in human and canine lipomas and the preclinical work in uterine fibroids. We also will be working with our partner Auxilium to advance additional indications such as frozen shoulder and cellulite towards potential commercialization."

Xiaflex was originally approved in 2010 for Dupuytren's contracture, which is a condition in which the fingers become bent and cannot be straightened out.

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