FDA clinical trial penis
Auxilium Pharmaceuticals Inc. (AUXL) won approval to expand use of its hand-disorder drug Xiaflex to treat men with curvature of the penis from a painful buildup of scar tissue. The company’s shares climbed on the approval.
The Food and Drug Administration cleared the injection that uses enzymes to break down the scar tissue under the skin of the penis, a condition called Peyronie’s disease, the agency said today in a statement. Men with the disease develop an abnormal curvature of the penis resulting in painful erections and difficulty having sex. Xiaflex is approved for men whose deformity leads to a bend of at least 30 degrees upon erection, the FDA said.
Surgery has been the only viable option for patients, which doesn’t always work well and can shorten the penis or cause impotence, Daniel Elliott, a urologist at the Mayo Clinic in Minnesota, said in an interview. As a result, only about 6, 500 of about 120, 000 men who are diagnosed with Peyronie’s each year are treated with injectables or surgery, Chesterbrook, Pennsylvania-based Auxilium said in a Nov. 25 statement.
“When I get involved and start doing surgery, we’re able to bypass the problem with some sort of alternative, but it’s never as good as the original equipment so to speak, ” Elliot said.
Xiaflex was approved as a treatment for a hand condition in which collagen builds up and prevents fingers from straightening. The drug generated $55 million in U.S. sales in 2012, according to data compiled by Bloomberg.
The therapy consists of a maximum of four treatment cycles that each include two Xiaflex injections directly into the collagen, FDA said. The drug is only available through certified doctors in certified health-care facilities because of the potential for serious risks, including penile fracture.
BioSpecifics Technologies Corp. (BSTC), based in Lynbrook, New York, developed Xiaflex and will receive low double-digit royalties based on a percent of sales, the company said in a regulatory filing.
Trauma can cause the scarring on the penis, while many patients also don’t know the origin of their condition.
Xiaflex improved penile curvature a mean 34 percent compared to 18 percent in men who received a placebo in two clinical studies in which patients received as many as eight injections during four treatment cycles done six weeks apart, according to results published in February in The Journal of Urology.
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