HealthDay News — The FDA has expanded the indication for collagen clostridium histolyticum (CCH, Xiaflex) to treat penile plaque accumulation that results from abnormal curvature of the penis, known as Peyronie’s disease.
Peyronie’s disease can cause pain, interfere with sexual function and severely affect men’s quality of life. CCH is an enzyme that dissolves the plaque and can alleviate curvature and associated symptoms in conjunction with physical therapy.
The drug — first sanctioned three years ago to treat Dupuytren’s contracture, another connective tissue disorder that affects the hands and fingers — is the first medication to be approved by the agency to treat Peyronie’s.
“Today’s approval expands the available treatment options for men who experience Peyronie’s disease and enables them, in consultation with their doctor, to choose the most appropriate option,” Audrey Gassman, MD, deputy director of the FDA division of bone, reproductive and urologic products, said in a statement.
The new indication for Peyronie’s disease covers men who have penile curvature of at least 30° and specifies a maximum of four treatment cycles with CCHD, with each cycle consisting of two injections and one penile remodeling procedure performed by a health care professional.
The injected drug will be available for restricted use due to significant risk for “serious penile injury,” and will require a Risk Evaluation and Mitigation Strategy (REMS), the FDA said.
The REMS for CCH requires healthcare professionals to complete a training program for administration of CCH to patients with Peyronie’s disease. Both the health care professional and the associated facility must be certified for use, the agency added.
CCH’s approval was based on data from two randomized double-blind, placebo-controlled studies that involved 832 men with Peyronie’s disease. At 52-week follow-up, patients treated with CCH had significantly reduced penile curvature deformity and related bothersome symptoms compared with placebo.
The most common side effects are penile hematoma, swelling and pain. There is a risk for serious problems, including penile fracture, and the drug should be given by a health care professional with experience in treating male urological diseases, the FDA said.
CCH is marketed by Auxilium Pharmaceuticals, based in Chesterbrook, Penn.