MALVERN, Pa. (AP) – Auxilium Pharmaceuticals Inc. said its drug Xiaflex worked as a treatment for a condition that causes curvature of the penis and makes sex difficult.
Xiaflex was previously approved in 2010 as a treatment for Dupuytren’s contracture, which causes the tendons of the hand to thicken and shorten and makes the fingers curve inward.
Auxilium is also testing the drug as a treatment for Peyronie’s disease, which is caused by development of scar tissue that can harden and curve the penis. The company said the drug reduced that abnormal curvature in two late-stage clinical trials.
Auxilium said it plans to file for marketing approval of Xiaflex as a treatment for Peyronie’s disease by the end of 2012. The company said it believes the condition is diagnosed in 65,000 to 120,000 men per year, and 5,000 to 6,500 people per year are treated with surgery or injectable therapies for the condition. It said Xiaflex would be the first biologic therapy for Peyronie’s disease.
The most common side effects in the trial were bruising, pain and swelling at the injection site. Most of those side effects cleared up within two weeks.
The Food and Drug Administration approved Xiaflex in early 2010. Auxilium reported a total of $56.4 million in Xiaflex revenue in 2011 and $14.9 million in the first quarter of 2012. In both periods, that was about 20 percent of the company’s revenue.
Date: June 4, 2012
Source: Associated Press
Filed Under: Drug Discovery