FDA approves first drug for sexual desire disorder

FDA approved Addyi flibanserin from Sprout Pharmaceuticals Inc. (Raleigh, N.C.) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. The agency said Addyi is the first drug approved for the indication. Sprout plans to launch the drug by Oct. 17.

The approval includes a REMS requiring prescriber and pharmacist certification. Addyi's label will include a boxed warning noting risks of severe hypotension and syncope in patients who drink alcohol, use moderate or strong cytochrome P450 3A4 ( CYP3A4) inhibitors, or have liver impairment. Use of Addyi is contraindicated in all three patient groups. ...