Men with a condition that causes a curvature of the penis now have a drug treatment option that has been approved by the Food and Drug Administration.
Today, the agency said it had approved the drug Xiaflex to treat Peyronie’s disease, a condition that causes a curvature in the penis, which can make it difficult for men to achieve erections, or make erections painful.
The curvature is caused by scar tissue under the skin of the penis, which is felt as a lump, and may develop after injury to the penis, such as a ruptured blood vessel occurring during sex or athletic activity, according to the Mayo Clinic.
It's not clear exactly how many men have Peyronie’s disease, but it's estimated to be somewhere around 1 to 3 percent, according to Weill Cornell Medical College. However, this could be an underestimate because some men may not know they have the condition, or may not disclose it.
While some drugs have been used to treat Peyronie’s disease, these drugs were approved for other conditions. Xiaflex is the first drug to be approved specifically for the purpose of treating Peyronie's disease. Surgery is also a treatment option. [8 Wild Facts About the Penis]
"Today’s approval expands the available treatment options for men experiencing Peyronie’s disease," Dr. Audrey Gassman, deputy director of the Division of Bone, Reproductive and Urologic Products in the FDA’s Center for Drug Evaluation and Research, said in a statement.
Xiaflex is for men who have a lump in the penis that results in a curvature of at least 30 degrees upon erection, the agency said.
It is thought that Xiaflex breaks down the connective tissue that causes the deformity, the agency said.
The FDA based their approval on two randomized, controlled trials of 832 men with Peyronie’s disease who were followed for a year. The drug significantly reduced penis curvature and symptoms compared with a placebo, the agency said.
The most common side effects of the drug were penile hematoma (a collection of blood under the skin), penile swelling and penile pain, the FDA said.
However, the drug can have serious side effects, including penile fracture. For this reason, doctors must undergo a certification before they can prescribe the drug.Copyright 2013 LiveScience, a TechMediaNetwork company. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
- Pharmaceuticals & Drug Trials
- Food and Drug Administration