Peyronie’s Disease/Xiaflex

Peyronie’s disease is a disorder in which scar tissue, called a plaque, forms in the penis—the male organ used for urination and sex. The plaque builds up inside the tissues of a thick, elastic membrane called the tunica albuginea. The most common area for the plaque is on the top or bottom of the penis. As the plaque builds up, the penis will curve or bend, which can cause painful erections. Curves in the penis can make sexual intercourse painful, difficult, or impossible. Peyronie’s disease begins with inflammation, or swelling, which can become a hard scar.

The plaque that develops in Peyronie’s disease is not the same plaque that can develop in a person’s arteries. The plaque seen in Peyronie’s disease is benign, or non-cancerous, and is not a tumor. Peyronie’s disease is not contagious or caused by any known transmittable disease.

Treatment of Peyronie’s

The treatment for Peyronie’s disease depends on the severity. For some men, the problem resolves on its own or the curve is not bothersome.  For others, the symptoms are severe and will require treatment.

A number of options are available for treatment of Peyronie’s disease. Most studies note using oral PD medications do not offer any benefit.  Intra-lesional therapy that is injected directly into the Peyronie’s plaque is used to stop collagen synthesis and increase collagenase activity. Verapamil and Interferon injections have been associated with PD improvement in placebo-controlled studies.   Traction therapy of the penis (wearing a medical device specifically designed to pull the penis) has shown improvement in curvature and length. Surgical treatments for Peyronie’s disease are usually recommended for patients with chronic disease that are unable to have intercourse. There are different types of surgical corrections that may be recommended to straighten the curvature of the penis.

XIAFLEX is a prescription medicine used to treat adult men with Peyronie’s disease who have a “plaque” that can be felt and a curve in their penis greater than 30 degrees when treatment is started.

Prescription XIAFLEX is injected into the scar tissue or Peyronie’s plaque. Each injection of XIAFLEX works to help weaken and break down the plaque and help straighten the curve caused by Peyronie’s disease.

It is not known if XIAFLEX is safe and effective in children under the age of 18.

Get the Facts about Peyronie’s Disease Urology Care Foundation

FDA approves first drug treatment for Peyronie’s disease

FDA NEWS RELEASE

For Immediate Release: Dec. 6, 2013
Media Inquiries: Andrea Fischer, 301-796-0393301-796-0393, andrea.fischer@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA888-INFO-FDA

The U.S. Food and Drug Administration today approved a new use for Xiaflex (collagenase clostridium histolyticum) as the first FDA-approved medicine to treat men with bothersome curvature of the penis, a condition known as Peyronie’s disease.

Xiaflex is the first FDA-approved non-surgical treatment option for men with this condition, who have a plaque (lump) in the penis that results in a curvature deformity of at least 30 degrees upon erection.

Peyronie’s disease is caused by scar tissue that develops under the skin of the penis. This scar tissue causes an abnormal bend during erection and can cause problems such as bothersome symptoms during intercourse.

“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 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.

Xiaflex is a biologic medicine (made from the protein product of a living organism, collagenase clostridial histolyticum). Xiaflex was first approved by the FDA in 2010 for the treatment of Dupuytren’s contracture, a progressive hand disease that can affect a person’s ability to straighten and properly use their fingers. Xiaflex is believed to work for Peyronie’s disease by breaking down the buildup of collagen (a structural protein in connective tissue) that causes the curvature deformity.

A treatment course for Peyronie’s disease consists of a maximum of four treatment cycles. Each treatment cycle consists of 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 the healthcare professional.

The safety and effectiveness of Xiaflex for the treatment of Peyronie’s disease were established in two randomized double-blind, placebo-controlled studies in 832 men with Peyronie’s disease with penile curvature deformity of at least 30 degrees. Participants were given up to four treatment cycles of Xiaflex or placebo and were then followed 52 weeks. Xiaflex treatment significantly reduced penile curvature deformity and related bothersome effects compared with placebo.

When prescribed for the treatment of Peyronie’s disease, Xiaflex is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) because of the risks of serious adverse reactions, including penile fracture (rupture of one of the penile bodies within the penile shaft, also known as corporal rupture) and other serious penile injury. Xiaflex for the treatment of Peyronie’s disease should be administered by a healthcare professional who is experienced in the treatment of male urological diseases. The REMS 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 healthcare professionals.

The most common adverse reactions associated with the use of Xiaflex for Peyronie’s disease include penile hematoma, penile swelling, and penile pain.

Consumers and health care professionals are encouraged to report adverse reactions from the use of Xiaflex to the FDA’s MedWatch Adverse Event Reporting program at https://www.fda.gov/MedWatch or by calling 1-800-FDA-10881-800-FDA-1088.

Xiaflex is marketed by Auxilium Pharmaceuticals, Inc., based in Chesterbrook, Pa.



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