New Drug Approved for Peyronie's Disease12/06/13
FRIDAY, Dec. 6, 2013 (HealthDay News) -- Xiaflex (collagenase clostridium histolyticum) has been approved by the U.S. Food and Drug Administration to treat Peyronie's disease, an uncomfortable curvature of the penis.
The drug -- first sanctioned three years ago to treat a hand deformity called Dupuytren's contracture -- is the first medication to be approved by the agency to treat Peyronie's.
The condition occurs when scar tissue forms under the skin, causing a curvature of the penis of at least 30 degrees, the FDA said Friday in a news release. This can lead to problems including "bothersome symptoms" during intercourse, the agency said.
The injected drug will be available for restricted use due to significant risk for "serious penile injury," the FDA said. Both the healthcare professional and the associated facility must be certified for use, the agency added.
Potential side effects of the drug and a related non-surgical procedure include bruising, swelling and pain, the FDA said.
Xiaflex is marketed by Auxilium Pharmaceuticals, based in Chesterbrook, Penn.
The FDA has more about this approval.
Copyright © 2013 HealthDay
. All rights reserved.
Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.