Sprout Pharmaceuticals Presents Phase 1 Clinical Trial Data Showing Treatment With Flibanserin Results In No Next-Day Driving Impairment

RALEIGH, N.C., Nov. 22, 2014 /PRNewswire/ -- Sprout Pharmaceuticals today 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 data were presented at the 20^th Annual Fall Scientific Meeting of the Sexual Medicine Society of North America in Miami.

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.

"With these preliminary results, Sprout has taken a key step toward the approval of flibanserin. The data are consistent with previous Phase 1 and Phase 3 safety data and further support our view that flibanserin has a favorable safety profile for women suffering with HSDD," said Cindy Whitehead, president and chief operating officer of Sprout Pharmaceuticals. "We believe that our planned NDA resubmission, which will include these new safety data, in addition to the previously submitted data in more than 11,000 patients, should result in women having the first ever treatment for Hypoactive Sexual Desire Disorder."

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.

Trial Design and Results

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. 

About Hypoactive Sexual Desire Disorder (HSDD)
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.

About Flibanserin
Flibanserin is a novel, non-hormonal drug that has been studied in clinical trials for the treatment of HSDD in premenopausal and postmenopausal 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 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.

For more information or the latest news about Sprout Pharmaceuticals, visit www.sproutpharma.com.

Media Contact:
Geoff Curtis
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312-550-8138 (c)
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SOURCE Sprout Pharmaceuticals