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Erectile Dysfunction Health Center

Treatment for Painful Curved Penis Shows Promise

Xiaflex up for FDA approval later this year, but some experts think injections required would be a tough sell
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Lee, who has been dealing with Peyronie's for about two years, has used a "straightening machine" that stretches the penis, and he participated in one of two clinical trials for a new drug that is up for review by the U.S. Food and Drug Administration: Xiaflex, produced by Auxilium Pharmaceuticals Inc. He said his penis is now 70 percent of its pre-disease length as a result of the interventions.

Xiaflex, which breaks down the scar tissue that is a component of penile plaque, was approved by the FDA in 2010 to treat Dupuytren's contracture, an inherited connective tissue disorder that causes the fingers to bend toward the palm. The concept of using Xiaflex with Peyronie's is based on some common features of both diseases. The hand condition is caused by an abnormal buildup of a substance called collagen. Fingers begin to bend toward the palm and the patient cannot straighten them.

The two clinical trials designed to test how Xiaflex worked in people with Peyronie's disease -- done in 2011 and 2012 -- together involved a total of 551 patients who received Xiaflex and 281 who were given a placebo. Each participant received four to six injections with a small needle into the penis every 25 to 72 hours over a period of several weeks. "The results showed people got a 30 percent improvement in curvature, which is clinically significant in terms of function," Lipshultz said

Recent data on the treatment appeared online in February and will be published in the July print issue of the Journal of Urology.

Lipshultz, who was involved in the clinical trials and is paid by Auxilium to speak to physicians about the treatment, said the company thinks Xiaflex will be approved by the FDA by mid-September.

Yet, Kavaler expressed concerns about whether Xiaflex will be helpful.

"The data show it looks like the drug made people feel better about their condition, maybe because they were getting treatment in the clinical trial, but I'm not sure if functionally it made a big difference," she said. "I don't think I could convince somebody to let me inject their penis four to six times with the hope of getting some small improvement."

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