WASHINGTON (AP) — The multi-decade search for a pill that boosts sexual desire in women hit another roadblock, raising questions about the future of efforts to develop a female equivalent to Viagra.
Sprout Pharmaceuticals said Wednesday it reached an impasse with the Food and Drug Administration about its drug, flibanserin. The daily pill is designed to increase libido in women by acting on brain chemicals linked to mood and appetite.
The FDA questioned whether the drug’s benefits outweigh its risks, considering its “modest” effectiveness and side effects including fatigue, dizziness and nausea.
Sprout, based in Raleigh, N.C., said it is appealing an October letter from the FDA that denied approval and asked for more information. But chances for approval appear slim: Of the 17 appeals FDA considered last year, 14 were denied, according to government figures.
The agency’s latest rejection raises serious questions for more than a half-dozen companies working to develop therapies for women who report stress because of lack of libido.
But unlike sexual problems in men, most of women’s sexual issues are psychological, not physical. As a result, there are a number of alternate causes doctors must consider before diagnosing female sexual desire disorders, including relationship problems, hormone disorders, depression and mood issues caused by other medications.