Men who suffer with symptoms of Peyronie’s disease, which is characterized by a painful penis that may be bent at a 45 degree angle or more, have limited treatment options and none approved by the Food and Drug Administration (FDA). That may change soon, as an experimental drug for Peyronie’s disease has done well in two recent, 52-week trials.
Peyronie’s disease is not only painful and embarrassing, it is also difficult to treat. That difficulty arises partly from not completely understanding what causes the penis to bend, become painful, and frequently make sexual intercourse impossible, although trauma to the penis, undergoing a prostatectomy for prostate cancer, and diabetes have been named as contributors.
Auxilium Pharmaceuticals hopes to change the drug options for men with this penile deformity by getting FDA approval for its drug Xiaflex for Peyronie’s disease treatment.
Currently, Xiaflex has FDA approval for Dupuytren’s contracture, a disease in which the fingers are permanently bent inward toward the palm and a condition often seen in men who have Peyronie’s disease.
In the two new trials, which had more than 800 participants, injections of Xiaflex reduced the curvature of the penis significantly more than placebo. For example, in one trial the average curvature for men who received Xiaflex declined from 48.8 degrees to 31.0 degrees one year later, compared with a decline from 49.0 degrees to 39.0 degrees in the placebo group.
If Xiaflex is approved by the FDA for Peyronie’s disease, it will provide men with a viable treatment option in a field currently with few choices. According to Dr. Culley C. Carson III, a professor of urology at the University of North Carolina and one of the investigators, “it’s a major advantage over what we have now, which is nothing.”
Pollock A. Treatment for penis curvature sees results. New York Times. 2012 Jun 3