'Female Viagra' Hits New Impasse With FDA

Dec 11, 2013 12:45 PM PST

WASHINGTON — Flibanserin, a libido-enhancing drug for women, has once again been kicked to the curb by wary members of the FDA. But its developers aren’t giving up yet.

After being rejected twice by the FDA since 2010, including once in October, Sprout Pharmaceuticals, where the drug is being developed, has already filed an appeal for FDA approval.

Often hailed as the “female Viagra,” Flibanserin purports to act on the neurotransmitter Dopamine to increase sexual appetite in women with low sex drives.

The FDA has questioned whether the drug's benefits outweigh its risks, considering its reportedly modest effectiveness coupled with its uncomfortable side effects, that include fatigue, dizziness and nausea.

Women taking the drug reported 1.7 more satisfying sexual experiences per month than those taking a placebo — a statistically significant effect, but not one strong enough to sway to the FDA.

Critics of the drug outside the FDA, including psychiatrists and medical doctors, have suggested that female sexuality may be too complex to confront with a single-pill solution.

"A pill just doesn't take care of it," said Dr. Virgina Sadock, who teaches human sexuality at New York University's School of Medicine. "You may take a statin drug to control your cholesterol, great. But you should also exercise and you should also watch your diet."

Sprout execs believe that approving their drug is the first step towards making progress with the issue, given that there are no other extant pharmaceutical options for hyposexual women.

The FDA does not comment on drugs under appeal, but is expected to make a decision about Flibanserin early next year. The Associated Press noted that of 17 appeals made to APA last year, 14 were rejected.  

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