Sprout resubmits NDA for flibanserin for hypoactive sexual desire disorder

Sprout Pharmaceuticals Inc. (Raleigh, N.C.) said it resubmitted an NDA to FDA earlier this year for flibanserin to treat hypoactive sexual desire disorder (HSDD). The company, which expects a decision on the application by year end, acquired the serotonin (5-HT1A) receptor agonist and 5-HT2A receptor antagonist from Boehringer Ingelheim GmbH (Ingelheim, Germany) in 2011. Boehringer discontinued development of flibanserin after FDA issued a complete response letter for the compound in 2010 (see BioCentury Extra, Oct. 8, 2010). ...