The U.S. Food and Drug Administration (FDA) today approved a drug for the treatment of Peyronie's disease, a medical condition that causes severe curvature of the penis. The drug, branded as Xiaflex, is the first FDA-approved medication for the treatment of the disease.
“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 Dr. Audrey Gassman, deputy director of Bone, Reproductive and Urologic Products at the FDA.
Peyronie's disease causes an abnormal bend in the penis while erect, and is caused by scar tissue that develops under the skin. The condition can cause sexual dysfunction, erectile dysfunction, shortening, and/or pain for men affected with it.
Treatment with Xiaflex involves multiple treatment cycles in which the drug is injected directly into a patient's penis, which then undergoes what the FDA refers to as "a penile modeling procedure performed by [a] health care professional." The drug is already FDA approved for the treatment of Dupuytren's contracture, a disease that can cause patients to have difficulty straightening their fingers.
The FDA approval comes after two clinical trials that were found to significantly reduce penile curvature in more than 800 men over the course of one year.
Though approved, Xiaflex does carry the risk of "serious adverse reactions," including possible penile fracture. Due to the risks, the drug may only be prescribed for the treatment of Peyronie's under a restricted program through a Risk Evaluation and Mitigation Strategy administered by a doctor with urological disease treatment experience.