Sprout Pharmaceuticals to resubmit NDA for flibanserin

US privately-held sexual health specialists Sprout Pharmaceuticals has received ‘clear guidance’ from the US Food and Drug Administration after a Formal Dispute Resolution was filed in December 2013.

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.