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 drugs 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, Sprouts pill almost doubled the increase women saw in satisfying sexual experiences over a months time compared with patients who took a placebo, the company said. The agencys 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. Its pretty well defined.

The FDA accepted Sprouts appeal on Dec. 3 after turning down the drug about two months ago. Because Sprout isnt publicly traded, the company didnt make public when the pill was rejected.

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 havent yet gone through menopause.

I think this could be a blockbuster drug, Whitehead said.

Sprout expects to hear FDAs decision on its appeal in the first quarter of next year.

Treatments for female sexual dysfunction have lagged behind those for men in the 15 years since Pfizer Inc. (PFE)s Viagra was approved for erectile dysfunction. Treatment for men has since grown into a $4.4 billion market in 2012, according to data compiled by Bloomberg.

Pfizer gave up studying Viagra for women in 2004. BioSante Pharmaceuticals Inc.s testosterone gel for women failed to work in two large studies in 2011.

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