ARTICLE | Clinical News

Flibanserin regulatory update

August 24, 2015 7:00 AM UTC

FDA approved an NDA from Sprout for Addyi flibanserin to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. The company said it plans to launch the serotonin (5-HT1A) receptor agonist and 5-HT2A receptor antagonist by Oct. 17.

The approval includes a REMS requiring prescriber and pharmacist certification. Addyi will have 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 those patient groups. ...