The Food and Drug Administration (FDA) had answered prayers on Friday, of men affected by Peyronie's disease, by approving the first drug that can address the painful curvature of the male sex organ.
The governing body approved the use of Xiaflex as a non-surgical treatment for men affected by the condition. Peyronie's manifests with a lump that causes a curvature of the penis measured at a minimum of 30 degrees when erect. The condition is said to be caused by a scar tissue resulting to a bent organ that may be painful during sexual intercourse. Xiaflex is an enzyme extracted from a bacterium that can break down the lump or plaque causing the painful deformity.
"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 deputy director Dr. Audrey Gassman of the Division of Bone, Reproductive and Urologic Products under the Center for Evaluation and Research of the FDA, in a press statement.
The approval of the FDA comes after two stages of clinical trials that involved 832 men afflicted with Peyronie's disease. The subjects were given four cycles of Xiaflex and a follow-up was done after 52 weeks. The drug significantly decreased deformity and pain of the patients.
"Xiaflex for the treatment of Peyronie's disease should be administered by a health care professional who is experienced in the treatment of male urological diseases. The REMS [Risk Evaluation and Mitigation Strategy] requires participating health care professionals to be certified within the program by enrolling and completing training in the administration of Xiaflex treatment for Peyronie's disease. The REMS also requires health care facilities to be certified within the program and ensure that Xiaflex is dispensed only for use by certified health care professionals," the FDA stated.
According to a report by The New York Times, the drug costs $3,300 per injection. With the complete treatment requiring eight shots in six weeks, one may spend around $26,000 plus doctor's fees.
The FDA listed penile pain, penile swelling, and penile hematoma as possible side effects in the administration of Xiaflex.
The drug is also used for the treatment of adult Dupuytren's contracture, a hand condition that affects that movement of the patient's fingers and hands caused by abnormal collagen buildup.
Auxilium Pharmaceuticals made Xiaflex in partnership with BioSpecifics Technologies.
