After lobbying push, drugmaker resubmits women's sex pill
Source: AP-Excite
By MATTHEW PERRONE
WASHINGTON (AP) — The makers of a twice-rejected pill designed to boost female libido are resubmitting their drug to federal health regulators, following a recent lobbying blitz by politicians, women's groups and consumer advocates aimed at pushing it onto the market.
Sprout Pharmaceuticals said Tuesday it is refiling its application for the drug, flibanserin, adding new information requested by the Food and Drug Administration about how the pill affects driving ability. FDA scientists requested that data after their most recent rejection of the drug, in part, due to results showing nearly 10 percent of women in company trials reported sleepiness as a side effect. The company studied women's driving ability the morning after taking flibanserin compared with women taking placebo and a common sleeping pill.
If approved, Sprout's daily pill would be the first drug for women who report a lack of sexual desire, a market that drugmakers have been trying to tap since the blockbuster success of Viagra for men in the late 1990s. But the drug has already faced a long, winding review at the FDA because of lackluster effectiveness and side effects including fatigue, dizziness and nausea.
In an effort to break the regulatory logjam, groups sponsored by Sprout and other drugmakers have begun publicizing the lack of a "female Viagra" as a women's rights issue.
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