Small Molecule / Compliance Management

Sprout Pharmaceuticals Resubmits NDA for Female Sex Drug

Feb 17, 2015

Sprout Pharmaceuticals has resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for flibanserin -- an investigational, once-daily, non-hormonal pill for Hypoactive Sexual Desire Disorder (HSDD) in premenopausal 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.”

Last February, Sprout announced that their Formal Dispute Resolution, filed in December 2013, resulted in clear guidance from the FDA on the path to resubmit the New Drug Application for flibanserin. At the request of the agency, Sprout 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.”

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