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FDA Asks for More Trials of Female Libido Treatment

Agency rejected flibanserin last year (February 11)

Sprout Pharmaceuticals has appealed the FDA’s complete response letter (CRL) for flibanserin, an investigational, once-daily treatment for hypoactive sexual desire disorder (HSDD) in premenopausal women.

The CRL was received in response to Sprout’s resubmission of a new drug application (NDA) for flibanserin earlier this year. The company’s resubmission included 14 new clinical studies with data on more than 3,000 new patients, expanding the number of subjects having completed clinical trials to more than 11,000.

The FDA has asked for three additional studies: two to test the interaction of flibanserin with other drugs, and a third to simulate driving since nearly 10% of women in clinical trials became sleepy while taking flibanserin.

The FDA rejected the drug last year saying its effects were “modest” and did not outweigh its adverse effects, such as dizziness, nausea, and fatigue. Sprout appealed the decision, and women’s groups have been pressing the FDA to approve the product, claiming gender bias in the drug approval process.

Flibanserin, a nonhormonal treatment, is believed to work on key neurotransmitters in the brain that affect sexual desire. More specifically, it is thought that flibanserin corrects an imbalance of levels of these neurotransmitters by increasing dopamine and norepinephrine (both responsible for sexual excitement) and by decreasing serotonin (responsible for sexual inhibition).

Sources: Sprout Pharmaceuticals; February 11, 2014; and Reuters; February 11, 2014.

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