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News From the Food and Drug Administration
October 6, 2015

New Drug for Sexual Desire Disorder

JAMA. 2015;314(13):1332. doi:10.1001/jama.2015.11901

The first drug to treat acquired generalized hypoactive sexual desire disorder (HSDD) in premenopausal women has gained FDA approval, with a boxed warning and special requirements for prescribers. Flibanserin, marketed as Addyi, is a serotonin 1A receptor agonist and a serotonin 2A receptor antagonist, but the mechanism by which it improves sexual desire and related distress is not known.

The drug’s approval “provides women distressed by their low sexual desire with an approved treatment option,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement (http://1.usa.gov/1PyaCOZ). “We are committed to supporting the development of safe and effective treatments for female sexual dysfunction.”

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