U.S. Drugmaker Complains of Deadlock With FDA Over Flibanserin, Female Sex Desire Booster

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By Vittorio Hernandez | December 16, 2013 10:12 AM EST

If men had been enjoying Viagra and other male erection enhancement drugs for almost 20 years, flibanserin, the equivalent of the sex enhancement drug for women, has suffered from another impasse with the regulator, the U.S. Food and Drugs Administration (FDA).

Sprout Pharmaceuticals, the manufacturer, reported the second rejection by the FDA of the drug, a daily pill designed to boost female libido by acting on brain chemicals linked to mood and appetite.

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In rejecting flibanserin, FDA questioned if the drug's benefits outweigh its risks. The regulator said the effectiveness was modest, while it pointed to side effects such as fatigue, dizziness and nausea.

In October, the FDA rejected the Sprout-made drug but asked for more information. Sprout appealed the decision, although based on the regulator's record of 14 rejections of 17 appeals in 2012, flibanserin's chances are said to be slim.

Besides Sprout, there are over half a dozen pharmaceutical firms developing medication for women who have low sex drive, often linked to stress. There are questions if women really need libido-boosting drugs since most of their sexual issues are psychological in nature, not physical.

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Doctors have been looking into other alternate causes why some women have low sex drive such as relationship problems, hormonal disorders, depression and mood issues caused by other drugs.

The development of female sexual dysfunction is made more difficult by the paucity of understanding of the root causes of lower sex drive among women.

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