Female Sexual Desire Drug Rejected by U.S. Regulators

A pill to treat low sexual desire in women was rejected by U.S. regulators, a decision that has been appealed by the drug’s maker in a bid to make it the first product for the disorder.

The U.S. Food and Drug Administration based its decision to turn down the medicine on what the agency called a modest effect, closely held Sprout Pharmaceuticals Inc. said today in a statement. Sprout, based in Raleigh, North Carolina, is seeking approval of the therapy, known as flibanserin, as an option for women whose low libido causes stress in their lives.

In clinical trials, Sprout’s pill almost doubled the increase women saw in satisfying sexual experiences over a month’s time compared with patients who took a placebo, the company said. The agency’s decision contrasts with its review of drugs to treat male sexual dysfunction, Cindy Whitehead, president and chief operating officer at Sprout, said in an interview. The agency on Dec. 6 issued its 24th approval of a treatment for male sexual dysfunction, an injection called Xiaflex to treat a condition that causes a curved penis.

“I do believe that women deserve a solution to their most common form of sexual dysfunction,” Whitehead said. “Flibanserin has been in 11,000 patients at this point. It’s pretty well defined.”
The FDA accepted Sprout’s appeal on Dec. 3 after turning down the drug about two months ago. Because Sprout isn’t publicly traded, the company didn’t make public when the pill was rejected.

Causes Stress  Flibanserin, if approved, would treat a sexual disorder known as female hypoactive sexual desire disorder, which is low libido that causes stress, according to Sprout. The drug is indicated for use by women who haven’t yet gone through menopause.
“I think this could be a blockbuster drug,” Whitehead said.
Sprout expects to hear FDA’s decision on its appeal in the first quarter of next year.