The U.S. Food and Drug Administration approved on Friday the first drug treatment that can help men suffering from an embarrassing disease called Peyronie’s disease.
Peyronie’s disease is caused by a scar tissue, called plaque, which forms along the length of the penis which can lead to having a curved penis. Thus, affected men suffer from occasionally painful sexual intercourse. It is still uncertain what can cause the scar tissue but there were beliefs that occasional hitting or bending of the penis after a trauma may be the reason behind the disease. Others suggest that it may be genetic. According to the National Institutes of Health, one percent of men have the disease and most are middle-aged. Generally, five to 19 percent of the cases simply disappear or recover on their own.
A number of treatments have been applied to cure and care for this disease but all were found ineffective. Men wanted an effective cure for the disease as it causes their penis to bend even after erection which is such an embarrassing site during a sexual act. Current options are surgery to remove the plaque and vitamin E therapy to stop it from growing back.
Finally, after thorough trials and testing, the FDA agreed that Xiaflex is an effective treatment for Peyronie’s disease. It is the very first approved and non-surgical treatment that can save men from this embarrassing disease.
Researchers believe that it will work for Peyronie’s disease by disintegrating the buildup of collagen that causes the curvature deformity.
The Xiaflex treatment consists of a maximum of four cycles, wherein each cycle will use two Xiaflex injection procedures -- in which Xiaflex is injected directly into the collagen-containing structure of the penis – and one penile modeling procedure performed by a licensed medical practitioner.
The research contributed to the approval of Xiaflex were established in two unsystematic double-blind, placebo-controlled studies in 832 Peyronie's disease patients with a penile curvature of at least 30 degrees.
Some of the participants were given up to four treatment cycles of Xiaflex, while some were given a placebo. After the introduction of the medication and the placebo, they were observed for 52 weeks.
It was found out that those who have received Xiaflex treatment displayed a significant reduced penile curvature deformity and related bothersome effects.
However, when allowed to go for the Xiaflex treatment of Peyronie's disease, is restricted to a program under Risk Evaluation and Mitigation Strategy (REMS) as it can cause serious adverse reactions like penile fracture and penile injury.
Experts strictly cautioned that administration of Xiaflex must be carried out by a licensed medical practitioner who is experienced in the treatment of male urological diseases.
Audrey Gassman, M.D., deputy director of the Division of Bone, Reproductive and Urologic Products in the FDA’s Center for Drug Evaluation and Research, said in the press release, “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.”
Xiaflex is marketed by Auxilium Pharmaceuticals, Inc., based in Chesterbrook, Pa.