The first drug to treat Peyronie’s disease — an embarrassing and sometimes painful curvature of the penis — won approval on Friday from the Food and Drug Administration.
The drug, Xiaflex, is made by Auxilium Pharmaceuticals. It estimates as many as 9 percent of men have the condition, which can make intercourse painful or impossible.
“It’s a soul-destroying disease,†said Stan Hardin, a plumber in Colorado Springs, who started the Association of Peyronie’s Disease Advocates after developing the condition 12 years ago. He said the approval offered hope to men, many of whom might now seek treatment.
Named after the French physician who first described it in 1741, the condition is caused by the buildup of plaque under the skin of the penis.
Xiaflex is an enzyme, derived from a gangrene-causing bacterium, that breaks down collagen, the main component of the plaque.
The approval was based on two clinical trials involving 832 men.
Treatment with Xiaflex consists of a series of eight injections in the penis, spaced six weeks apart.
Doctors who administer the drug will have to be specially trained and certified. Pain, swelling and bruising can develop in the injection area.
Xiaflex costs $3,300 an injection, so a full course of eight injections would cost about $26,000, in addition to a doctor’s fee. Doctors already use less expensive drugs off-label to treat Peyronies, including injections of a generic blood pressure drug.
Auxilium, based in Chesterbrook, Pa., a Philadelphia suburb, is setting up a program to help patients obtain insurance reimbursement. It has also started a disease awareness campaign.
BioSpecifics Technologies, a small company in Lynbrook, Long Island, will receive royalties from Auxilium. BioSpecifics spent half a century trying to develop the drug, nearly going out of business in the process.
Xiaflex was first approved in 2010 to treat Dupuytren’s contracture, a condition in which fingers are bent toward the palm and cannot be straightened.
Sales have been below expectations, in part because hand surgeons, the main doctors administering Xiaflex, make more money by performing surgery to relieve the condition. Auxilium shares closed up 12 percent, to $21.64 on Friday. s of BioSpecifics were up nearly 7 percent.