SproutPharma receives FDA guidance on flibanserin for Hypoactive Sexual Desire treatment

Sprout Pharmaceuticals announced that their Formal Dispute Resolution, which was filed in December 2013, resulted in clear guidance from the FDA on the path forward. Sprout will resubmit the New Drug Application (NDA) for flibanserin, a once-daily treatment for Hypoactive Sexual Desire Disorder (HSDD) in premenopausal women, by the third quarter.

The FDA has requested that Sprout complete two additional Phase I drug interaction studies and a Phase I driving simulator study. Consistent with their Phase I nature, each study is expected to include approximately 25-50 healthy volunteers. These studies will answer interaction questions on different enzyme pathways than those already studied, as well as identify if there is any possible driving impairment, as 9.8% of women experience somnolence, or sleepiness, while on flibanserin 100mg.