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Drugmaker resubmits women’s sex pill

WASHINGTON — The makers of a twice-rejected pill designed to boost sexual desire in women are hoping a yearlong lobbying push by politicians, women’s groups and consumer advocates will move their much-debated drug onto the market.

The ongoing saga of Sprout Pharmaceutical’s female libido drug illustrates the complicated politics and unresolved science surrounding women’s sexuality.

For decades, drugmakers have tried unsuccessfully to develop a female equivalent to Viagra, the blockbuster drug that treats men’s erectile dysfunction drug by increasing blood flow. But disorders of women’s sexual desire have proven resistant to drugs that act on blood flow, hormones and other simple biological functions.

Supporters of Sprout’s drug say women’s sexual disorders have been overlooked for too long by regulators at the Food and Drug Administration. But critics argue that women’s sexuality is too complex to be addressed by a single pill.

Sprout’s drug flibanserin is the first attempt to increase libido by acting on brain chemicals linked to appetite and mood. But the Food and Drug Administration has already twice rejected the drug 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.

“Women deserve equal treatment when it comes to sex,” states an online petition to the FDA organized by one such group, Even the Score, which garnered almost 25,000 supporters. The group’s corporate backers include Sprout Pharmaceuticals, Palatin Technologies and Trimel Pharmaceuticals — all companies developing drugs to treat female sexual disorders. A spokeswoman for Blue Engine Media, the public relations group for Even the Score, declined to disclose how much of the group’s funding comes from companies. The group’s nonprofit supporters include the Women’s Health Foundation, the Institute for Sexual Medicine and other organizations.

Drugmakers frequently cite a 1999 survey in the Journal of the American Medical Association that found 43 percent of U.S. women had some type of sexual dysfunction.

Sprout said Tuesday it is refiling its application for flibanserin, adding new information requested by the FDA 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.

If approved, flibanserin would be labeled for premenopausal women with hypoactive sexual desire disorder, described as a lack of sexual appetite that causes emotional distress. Because so many factors affect female sexual appetite, there are a number of other possible causes doctors must rule out before diagnosing the condition, including relationship problems, hormone disorders, depression and mood issues caused by other drugs like sleeping aids and pain medications.