FDA Approval for "Female Viagra"

August 19, 2015

August 18, 2015.

The U.S. Food and Drug Administration (FDA) has approved Addyi (flibanserin) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Prior to Addyi’s approval, there were no FDA-approved treatments for sexual desire disorders in men or women. The treatment has become popularly known as "female viagra".

HSDD is characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition.

Addyi is being approved with a risk evaluation and mitigation strategy (REMS), which FDA is requiring because of the increased risk of severe hypotension and syncope due to the interaction between Addyi and alcohol. The drug is also being approved with a Boxed Warning to highlight the risks of severe hypotension and syncope in patients who drink alcohol during treatment with Addyi, in those who also use moderate or strong CYP3A4 inhibitors, and in those who have liver impairment. 

FDA reports that it "has recognized for some time the challenges involved in developing treatments for female sexual dysfunction". Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER) said “Today’s approval provides women distressed by their low sexual desire with an approved treatment option".

Source: FDA

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