Thursday, December 12, 2013

FDA Clears First Drug Treatment for Peyronie's Disease


The US Food and Drug Administration (FDA) has approved collagenase clostridium histolyticum (Xiaflex, Auxilium Pharmaceuticals) for the treatment of men with Peyronie's disease.
"Xiaflex is the first FDA-approved non-surgical treatment option for men with this condition, who have a plaque (lump) in the penis that results in a curvature deformity of at least 30 degrees upon erection," the FDA said in a statement.
Peyronie's disease affects about 5% of men. It is caused by scar tissue that develops under the skin of the penis, which causes an abnormal bend during erection and can cause problems such as bothersome symptoms during intercourse.
Collagenase C histolyticum is believed to work for Peyronie's disease by breaking down the buildup of collagen (a structural protein in connective tissue) that causes the curvature deformity, according to the FDA.
As reported by Medscape Medical News, collagenase C histolyticum was first approved by the FDA in 2010 for thetreatment of Dupuytren's contracture, a progressive hand disease that can affect a person's ability to straighten and properly use their fingers.
The safety and effectiveness of collagenase C histolyticum for treatment of Peyronie's disease were established in 2 randomized double-blind, placebo-controlled studies in 832 men with Peyronie's disease with penile curvature deformity of at least 30 degrees.
As reported by Medscape Medical News, participants were given up to 4 treatment cycles of collagenase C histolyticum or placebo and were followed-up for 52 weeks. Treatment with collagenase C histolyticum significantly reduced penile curvature deformity and the related bothersome effects compared with placebo.
For Peyronie's disease, a clinician injects collagenase C histolyticum directly into the scar tissue, using a technique that requires training. One cycle of treatment involves 2 injections 24 to 72 hours apart. Treatment consists of a maximum of 4 treatment cycles. The most common adverse reactions include penile hematoma, penile swelling, and penile pain.
"Today's approval expands the available treatment options for men experiencing Peyronie's disease, and enables them, in consultation with their doctor, to choose the most appropriate treatment option," said Audrey Gassman, MD, deputy director of the Division of Bone, Reproductive and Urologic Products in the FDA's Center for Drug Evaluation and Research.
The FDA says collagenase C histolyticum for Peyronie's disease is available only through a risk evaluation and mitigation (REMS) program because of a risk for serious adverse reactions, including penile fracture and other serious penile injury. The treatment "should be administered by a health care professional who is experienced in the treatment of male urological diseases," the agency notes.
The REMS requires participating healthcare professionals to be certified within the program by enrolling and completing training in the administration of collagenase C histolyticum for Peyronie's disease. The REMS also requires certification of healthcare facilities to ensure the drug is dispensed only for use by certified healthcare professionals.

Healthcare professionals are encouraged to report adverse reactions from the use of collagenase C histolyticum to MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online athttps://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

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