Efficacy and Sedation-Related Safety of Flibanserin in Premenopausal Women

Author: Sexual Medicine Society of North America
Published: 23rd Nov 2014
Peer-Reviewed Publication: N/A
Additional References: Female Sexual Health Publications

Summary: Flibanserin for Hypoactive Sexual Desire Disorder (HSDD) does not impair next-day cognitive function or driving performance in premenopausal women.

Main Document

New data demonstrates that flibanserin, a novel, non-hormonal medicine being investigated for the most common form of female sexual dysfunction, Hypoactive Sexual Desire Disorder (HSDD), does not impair next-day cognitive function or driving performance in premenopausal women when taken at bedtime. The data was presented at the Sexual Medicine Society of North America's (SMSNA) 20th Annual Fall Scientific Meeting in Miami.

SMSNA accepted this study as a late breaking abstract for presentation under criteria that it could have a material impact on the field of sexual medicine within the next six months.

"We're at a pivotal inflection point nearing what we hope will be the first FDA-approved medicine for HSDD," said Dr. Lawrence S. Hakim, Chairman of Urology at Cleveland Clinic Florida and President of the Sexual Medicine Society of North American (SMSNA). "Thanks in large part to last month's landmark FDA meeting on treatments for female sexual dysfunction, interest in this issue has never been higher, both among the scientific community and among the millions of women who experience HSDD."

"Healthcare providers routinely question men about sexual health and have a variety of medical options for managing erectile dysfunction, low sexual desire and Peyronie's Disease," said Dr. Stanley Althof, Professor Emeritus, Case Western Reserve School of Medicine and Executive Director, Center for Marital and Sexual Health of South Florida. "A couple's sexual well-being can't be optimized by treating his erectile dysfunction and ignoring her sexual health."

The study, conducted by Sprout Pharmaceuticals and presented by Dr. Noel Kim, Senior Investigator, Institute for Sexual Medicine, examined the sedation-related safety of flibanserin, which has been studied in more than 11,000 clinical trial participants. The medicine showed no impairment of next day cognitive function even after women were given double the recommended dose of 100 mg, according to the study results.

During the study, 72 women completed a cumulative total of 576 drives, encompassing more than 35,000 miles of simulated driving.

Potential next-day residual effects were evaluated the next morning after bedtime dosing in a preliminary analysis of a randomized, double-blind, placebo-controlled, four-way crossover study with validated assessments including simulated driving performance and symbol digit coding substitution test in healthy premenopausal women.

Driving and cognitive assessment scores indicated that flibanserin 100 mg was no worse than placebo for both acute and chronic dosing. Flibanserin 200 mg was similar to the 100 mg dose for cognitive testing and driving performance, although commonly reported AEs were predictably increased in a dose-dependent manner. Consistent with the phase three clinical trials for flibanserin, this new study shows no impairment of next day cognitive function, even after women were given double the recommended dose.

Last month, Dr. John Mulhall, incoming Editor of the Journal of Sexual Medicine and the Director of the Male Sexual and Reproductive Medicine Program at Memorial Sloan Kettering Cancer Center, led a group of more than 80 clinical experts specializing in male sexual dysfunction in sending a letter to the FDA applauding the Agency's decision to hold a two-day workshop focused on FSD. The experts noted that "as clinicians, we see on a daily basis the impact that sexual dysfunction has on the affected woman as well as her partner. We have seen, over the years, the benefits to women of treating their sexually dysfunctional male partners and we expect that treating the similarly affected woman will enhance not just her life but that of the couple."

The Sexual Medicine Society of North America is committed to the sexual health treatment of both genders and has established a Committee on Female Sexual Function to advise the Board of Directors of the SMSNA. "Female sexual health has largely gone unaddressed in in North America; we need to educate clinicians on how to identify and manage female sexual dysfunctions," said Dr. Gregory Broderick Professor of Urology Mayo Clinic and founding member of the SMSNA. The Committee on Female Sexual Health of the SMSNA will develop educational content for consumers, and health care providers.

The study's abstract may be found here: http://smsna.org/V1/index.php?option=com_content&view=article&id=196&abstract_id=190

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