Sprout Pharmaceuticals receives clear guidance from FDA on path forward to resubmit NDA for flibanserin

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.

Sprout Pharmaceuticals president and COO Cindy Whitehead noted the company is encouraged by the FDA’s response and view it as a significant step toward the approval of flibanserin.

"With data in over 11,000 patients to date, we are confident that further supporting the predictable risk/benefit profile of flibanserin will result in women having the first ever treatment for the most common form of female sexual dysfunction. We are committed to working closely with the Agency to finally provide premenopausal women affected by HSDD with a medical treatment option," Whitehead added.