Agency Proposes Select Phase I Studies as Part of Resubmission
Raleigh, N.C., February 11, 2014 – Sprout Pharmaceuticals announced today that their Formal Dispute Resolution, which was filed in December 2013, resulted in clear guidance from the FDA on the path forward. 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.
“We are encouraged by the FDA’s response and view it as a significant step toward the approval of flibanserin,” said Cindy Whitehead, president and chief operating officer of Sprout Pharmaceuticals. “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.”
About Hypoactive Sexual Desire Disorder
HSDD is the most commonly reported form of female sexual dysfunction. HSDD is defined as a persistent or recurrent deficiency or absence of sexual fantasies and desire for sexual activity that causes marked distress or interpersonal difficulty, and which is not better accounted for by a medical, substance-related, psychiatric (e.g., depression) or other sexual condition. The cause of HSDD is believed to involve a multitude of social, psychological and biological factors and may be attributed to a complex interplay of these factors.
Flibanserin is a novel, non-hormonal drug that has been studied in clinical trials for the treatment of HSDD in premenopausal and postmenopausal women. The application submitted to the FDA is for premenopausal women. Flibanserin is believed to work on key neurotransmitters, or chemicals, in the brain that affect sexual desire. More specifically, it is thought that flibanserin corrects an imbalance of levels of these neurotransmitters by increasing dopamine and norepinephrine (both responsible for sexual excitement) and decreasing serotonin (responsible for sexual inhibition). In clinical studies, flibanserin was evaluated for its ability to increase the frequency of satisfying sexual events, increase the intensity of sexual desire and decrease the associated distress women feel from its loss.
About Sprout Pharmaceuticals
Sprout Pharmaceuticals is passionate about women’s sexual health. With a breakthrough concept for women, the company “sprouted” out of Slate Pharmaceuticals in 2011. Based in Raleigh, NC, the company is focused solely on the delivery of a treatment option for the unmet need of millions of women with HSDD. Sprout is pursuing the FDA approval of flibanserin to treat HSDD in premenopausal women, for which there is currently no FDA-approved treatment.