PD occurs where plaque or scar tissue develops under the skin of the penis. The scar tissue hardens and causes a bend or arch of the penis during erection. Another symptom is pain during intercourse. The condition may affect up to 9% of men in the U.S.
The new drug, called Xiaflex, is the first non-surgical treatment for men with an erect curvature deformity of at least 30 degrees.
"For this physically and psychologically devastating disorder, Xiaflex is the first FDA-approved, in-office treatment to be administered non-surgically," said Martin K. Gelbard, M.D., clinical trial investigator and clinical faculty member of UCLA School of Medicine, Department of Urology.
Made by Auxillian, the drug was first approved by the FDA in 2010 for a disease that affects a person's ability to straighten their fingers.
The safety and effectiveness of the drug was established in studies of 832 men with penile curvature deformity. After one year, the drug "significantly reduced penile curvature deformity and related bothersome effects compared with placebo."
Xiaflex is a drug made from the protein of a living organism called collagenase clostridial histolyticum. Delivered by needle injection, the drug works by breaking down the buildup of collagen (a structural protein in connective tissue) that causes the curvature.
Most common side effects include penile hematoma, swelling and pain.
For questions, Auxilium offers a free call center at: 1-877-942-3539.