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posted by martyb on Friday June 05 2015, @11:55AM   Printer-friendly
from the just-getting-started dept.

A committee of advisers to the U.S. Food and Drug Administration (FDA) are meeting to consider whether the FDA should approve the first drug that aims to boost a woman's libido:

The FDA has twice before rejected the drug, called flibanserin, after previous advisory panels concluded there were questions about its safety and insufficient evidence that the drug was effective for women with low sex drives. Sprout Pharmaceuticals, which makes flibanserin, has submitted more research that the company hopes will finally convince the advisers and the agency the drug is ready for the market. The company's evidence includes a study it says shows women can safely drive after using the medication. One concern about the drug is that it can leave women drowsy the day after taking it, increasing the risks for accidents. "The review of flibanserin... represents a critical milestone for the millions of American women and couples who live with the distress of this life-impacting condition without a single approved medical treatment today," Cindy Whitehead, Sprout's CEO, said in a statement before the hearing began.

Flibanserin, which the company plans to sell under the brand name Addyi if approved, shifts the balance of three key brain chemicals, increasing dopamine and norepinephrine and decreasing serotonin.

The drug has long been the focus of an intense debate. The company and some advocacy groups, including the National Organization for Women and Even the Score, have suggested that the FDA is being sexist by holding the drug to a higher standard than drugs, such as Viagra and Cialis, for male sexual problems. The FDA denies those charges. In documents posted online in advance of the hearing, Hylton Joffe, director of the FDA's Division of Bone, Reproductive and Urologic Products, said that such claims "are misleading and inaccurate." "The FDA rejects claims of gender bias," Joffe wrote. "The FDA's regulatory decision for each product is based on an assessment of whether the benefits outweigh the risks, and does not take gender into consideration." Many women's health advocates agree with the agency's caution and remain opposed to the drug despite the company's new research.


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  • (Score: 1, Redundant) by morgauxo on Friday June 05 2015, @01:26PM

    by morgauxo (2082) on Friday June 05 2015, @01:26PM (#192507)

    Wow, I bet you have a happy partner.

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