Recent clinical trials have shown encouraging results for the drug Xiaflex as a potential treatment for Peyronie’s disease.
Pennsylvania-based Auxilium Pharmaceuticals announced good results from two Phase III trials. In a Phase III trial, a drug is given to a large group of people to make sure it’s effective and watch for side effects. Auxilium plans to apply for approval from the U.S. Food and Drug Administration (FDA) by the end of this year. If approved by the FDA, the drug can then be marketed for the treatment of Peyronie’s disease.
Peyronie’s disease is believed to be caused by a wound to the penis that does not heal properly. As a result, areas of hardened scar tissue called plaques form on the shaft of the penis. The plaques interfere with flexibility, leading to a distinct curvature when the penis is erect. For some men, the curvature is noticeable, but not bothersome. But for others, the condition is painful and makes sexual intercourse impossible. Many men have emotional distress because of Peyronie’s disease.
Surgery is a common treatment for Peyronie’s disease, but because it can cause erectile dysfunction and penile shortening, it’s considered a last resort.
Xiaflex is already prescribed to treat Dupuytren’s contracture, a connective tissue disorder in the hand caused by thickened scar tissue. The condition cause fingers to curve or clench. The drug works by breaking down collagen, which forms the scar tissue.
Some men with Peyronie’s disease also have Dupuytren’s contracture.
Each Auxilium trial had approximately 400 participants. One trial took place in the United States; the other was in Australia. Some men received injections of Xiaflex; the rest received a placebo. A physician also manipulated the penis to break up the plaques.
In one trial, the men taking Xiaflex saw a mean curvature reduction of 38%. In the other, the mean reduction was 31%. In contrast, the men receiving placebo treatments experienced mean curvature reductions of 21% and 15%, respectively.
In both groups, the men who took Xiaflex reported less bother, fewer psychological and physical symptoms of Peyronie’s disease, and less pain.
The most common side effects of Xiaflex were hematoma (blood accumulation), pain, and swelling at the treatment site.
Auxilium estimates that between 65,000 and 120,000 cases of Peyronie’s disease are diagnosed each year in the United States.
Auxilium Pharmaceuticals, Inc.
“Auxilium Pharmaceuticals, Inc. Announces Positive Top-Line Results from Both Phase III Trials of XIAFLEX® for the Potential Treatment of Peyronie’s Disease”
(Press release. June 4, 2012)
“Question: What are clinical trial phases?”
(Last reviewed: April 18, 2008)
“Possible Help For Men With Peyronie’s, Crooked Penis Disease”
(June 8, 2012)
Los Angeles Times
Maugh, Thomas H., II
“Penis too curvy from Peyronie’s disease? A new drug might help”
(June 5, 2012)
New York Times
“Treatment for Penis Curvature Sees Results”
(June 3, 2012)
Nathan, Vidya L.
“Auxilium penile curvature drug meets study goal”
(June 4, 2012)
Sexual Medicine Society of North America
“Peyronie’s and Dupuytren’s Contracture”