FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs / Submissions and Approvals / Research and Development

Sprout to Resubmit NDA for Flibanserin After FDA Requests More Trial Data

Feb. 12, 2014

Sprout Pharmaceuticals said Tuesday it plans to resubmit the NDA for its sexual dysfunction drug flibanserin by the third quarter of this year after the FDA requested the sponsor conduct additional trials.

Flibanserin is an investigational, non-hormonal treatment for hypoactive sexual desire disorder (HSDD) in premenopausal women. The Raleigh, N.C.-based drugmaker cites data showing that 1 in 10 women are affected by HSDD, the symptoms of which include low sexual desire.

Sprout’s Phase I trials will focus on drug interaction over different enzyme pathways in the liver and on drowsiness in driving simulations, respectively, and will include approximately 25-50 healthy volunteers. Sprout spokesman Geoff Curtis told Drug Daily Bulletin that the company is seeking guidance from the FDA before beginning these trials. Fourteen previous trials, including two Phase I studies and 12 Phase III studies, collected data on over 11,000 patients, he added.

The company resubmitted an NDA in June 2013 with the results of a 1,000-patient Phase III trial that showed statistically significant improvements in sexual desire and satisfying sexual events compared with placebo. The agency responded with a complete response letter in December, which Sprout’s formal dispute resolution request appealed.

Flibanserin is thought to work by increasing levels of dopamine and norepinephrine and decreasing levels of serotonin in the brain in order to correct chemical imbalances that lead to low sexual desire in women, Sprout says. — Lena Freund

Subscribe to Drug Industry Daily for complete coverage of the pharmaceutical industry. Click here for more information.