Sprout Pharmaceuticals has announced that it has resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for a non-hormonal pill aimed to treat Hypoactive Sexual Desire Disorder (HSDD) in premenopausal women.
The investigational once-daily drug is called flibanserin, and would be the first FDA approved drug to treat this disorder, a news release reported.
"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."
In 2013 Sprout received a Complete Response Letter from the FDA for flibanserin, but appealed the FDA's decision. At the agency's request they completed a Phase 1 pharmacokinetic study and a Phase 1 driving study.
"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."
In the clinical trials including over 11,000 women, flibanserin was linked to significant improvements in sexual desire, sexual satisfaction, and stress caused by the disorder when compared with a placebo. The most common side effects seen in the clinical trials were nausea, dizziness, and sleepiness.
