December 28, 2014 6:30 PM ET


Company Overview of Sprout Pharmaceuticals, Inc.

Company Overview

Sprout Pharmaceuticals, Inc. develops products for treatment of female sexual health. The company was incorporated in 2011 and is based in Raleigh, North Carolina.

4208 Six Forks Road

Raleigh, NC 27609

United States

Founded in 2011



Key Executives for Sprout Pharmaceuticals, Inc.

Chief Financial Officer
Director and Secretary
Compensation as of Fiscal Year 2014.

Sprout Pharmaceuticals, Inc. Key Developments

Sprout Pharmaceuticals Announces Positive Preliminary Results from a Phase 1 Driving Stud

Sprout Pharmaceuticals announced positive preliminary results from a Phase 1 driving study, which demonstrate that women treated with flibanserin up to 200 mg at bedtime had no next-day impairment of driving ability. The Phase 1 driving study was completed in response to the Complete Response Letter and the Formal Dispute Resolution that was filed in December 2013. The study design, including the selection of primary endpoint and flibanserin and control groups, was developed in close consultation with the FDA. Sprout plans to resubmit the flibanserin New Drug Application in the first quarter of 2015. In addition to the Phase 1 driving study, Sprout has completed a Phase 1 drug interaction study and will include it as part of the NDA resubmission. The Phase 1, randomized, double-blind four-way crossover study was designed to assess next-day impairment in women treated with flibanserin, which was taken at bedtime, compared to women treated with zopiclone (a medication for insomnia that served as a positive control) and placebo. Eighty-three healthy women were randomized to one of four treatment arms and 72 completed the entire study. Treatments consisted of: flibanserin 100 mg for seven days; flibanserin 100 mg for six days and then flibanserin 200 mg on day seven; placebo for seven days and zoplicone for one day at the beginning and end of treatment (drives completed morning after first and last night dose). Next-day driving impairment was measured by the CRC driving simulator (CRCDS-MiniSim) and the primary endpoint was standard deviation of lateral position (SDLP), a validated assessment reflecting the degree of side-to-side movement on the road and hence, driver control. Completers of the study collectively participated in 576 drives for a cumulative total of 57,600 km of simulated driving. Specific results showing the difference in SDLP are as follows, Adverse events were consistent with the flibanserin safety profile exhibited in the phase 3 program. No serious adverse events were reported during the study and most adverse events (>98%) were mild to moderate in severity.

Sprout Pharmaceuticals Receives Clear Guidance from FDA on Path Forward to Resubmit New Drug Application for Flibanserin

Sprout Pharmaceuticals announced 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.

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