"Female viagra" leaves FDA unsatisfied

Studies fail to prove that the so-called "pink pill" can fix women's sex drive

Published June 16, 2010 9:50PM (EDT)

The feverish excitement over a "female Viagra" prototype has once again proven to be anticlimactic. Oh, Big Pharma, you're such a tease. 

The Food and Drug Administration announced Wednesday that flibanserin has performed poorly in two studies, failing to result in a significant increase in women's self-reported sexual desire. The cutesily nicknamed "pink pill" did manage to slightly increase the number of sexually satisfying romps (by 0.8 more than with the placebo), but that's not the aim of the drug. Its makers are seeking approval for use as a treatment for hypoactive sexual desire disorder, which is defined as a flagging sex drive in generally healthy pre-menopausal women.

Unlike past failed attempts at a female sex-drive drug that increased blood flow to the genitals or boosted testosterone levels, flibanserin targets a woman's brain chemistry. Originally tested as an antidepressant, it suppresses serotonin while pumping up levels of dopamine and norepinephrin. Dr. Peter Piliero, the drug maker's executive director for medical affairs, told the Associated Press: "We don't know specifically what the exact mechanism of action is but we believe it acts on brain chemicals that have a role in human sexual response." But, according to the FDA's preliminary review, the evidence doesn't bear that out. That doesn't mean the drug doesn't have a chance of approval, though -- on Friday, an FDA advisory panel will meet to debate its safety and effectiveness. 

Women who desperately desire a female sex-drive drug are no doubt crossing their fingers that the many prototypes and trials that have come before will be but foreplay ramping up to flibanserin's big finish. Meanwhile, those of us who are skeptical of the definition of female sexual dysfunction and the motivations behind the pursuit of "lady Viagra" are left once again saying: Quit it already, we're not in the mood.

By Tracy Clark-Flory

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