Sprout Pharmaceuticals announced today that it has resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for flibanserin, an investigational, once-daily, non-hormonal pill for Hypoactive Sexual Desire Disorder (HSDD) in pre-menopausal women. If approved, flibanserin will be the first and only FDA-approved treatment for HSDD. “This NDA resubmission marks the completion of the additional clinical studies requested by FDA,” said Cindy Whitehead, CEO of Sprout Pharmaceuticals.

“The FDA has devoted significant resources to understand HSDD and the need for medical treatment. I believe that the Agency’s efforts to bring together panels of patients and clinical experts will prove to be a significant step in bringing about a solution for women with HSDD to market. This year, I am optimistic that women and their partners affected by the life impact of HSDD will have their first potential medical solution”.

The resubmission comes after Sprout received a Complete Response Letter from the FDA for flibanserin in 2013. Sprout appealed the FDA’s decision, and at the request of the Agency, completed a Phase 1 pharmacokinetic study and a Phase 1 driving study. Results from these studies were included in the resubmission package. “The brain plays an important role in regulating a woman’s sexual desire, and one of the root causes of persistent and recurrent low sexual desire, or HSDD, stems from an imbalance of neurotransmitters in the brain,” said Stephen Stahl, Adjunct Professor of Psychiatry, University of California San Diego, School of Medicine.

“Flibanserin is believed to work by correcting this imbalance and providing the appropriate areas of the brain with a more suitable mix of brain chemicals to help restore sexual desire.”

Flibanserin was evaluated in three pivotal Phase 3, randomized, double-blind, placebo-controlled, parallel-group North American studies of premenopausal women with a mean age of 36 years. In all trials, flibanserin demonstrated a statistically significant difference compared to placebo on three key endpoints: an increase of sexual desire; a decrease in distress from the loss of sexual desire; and an increase in the frequency of satisfying sex.

For more details, go to: http://sproutpharma.com/sprout-pharmaceuticals-resubmits-flibanserin-new-drug-application-for-the-treatment-of-hypoactive-sexual-desire-disorder-in-premenopausal-women/