Sexual Dysfunction Drugs for Men vs. Women: A Case of Inequality

Contributed by Lisa Larkin, MD, FACP, NCMP, Associate Professor and Division Director, Midlife Women’s Health

ThinkstockPhotos-137861610“Spectacular science has emerged,” in the form of a novel non-hormonal pill shown to improve low sexual desire in women, says Sprout Pharmaceuticals CEO Cindy Whitehead. In clinical trials, flibanserin has shown promise in treating Hypoactive Sexual Desire Disorder (HSDD) and has been facing FDA approval difficulty since 2010.

On June 4, I’ve been asked to present to the FDA as they hold a Joint Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee to review the approval of flibanserin for HSDD. Flibanserin has shown to offer a favorable safety and efficacy profile for the treatment of HSDD.

As a Board Member of The International Society for the Study of Women’s Sexual Health (ISSWSH), the preeminent scientific organization focused on research, education, and clinical practice of women’s sexuality, I applaud the FDA’s recent announcement and am hopeful the prolonged development of flibanserin, a drug that could be the first approved medical treatment for distressing low sexual desire in women, will be seriously considered.

While there are 23 FDA-approved treatments for either erectile dysfunction or low testosterone in men, there is not one single FDA-approved drug to help sexual dysfunction in women. This is true despite the estimated 1 in 10 women in the United States that suffer from low sexual desire—that’s 16 million women. Low sexual desire can be associated with significant distress that goes way beyond the bedroom and affects every aspect of life, including body image, mood, self-confidence and self-worth.

While ISSWSH fully endorses the FDA’s evidence-based review of the risks and benefits of flibanserin, ISSWSH recognizes the significant unmet need for safe and effective medical therapies to address all women’s sexual problems.

James A. Simon, MD, former president of the North American Menopause Society, a colleague and my mentor was lead investigator of the SNOWDROP trial. Dr. Simon coauthored Efficacy and safety of flibanserin in postmenopausal women with hypoactive sexual desire disorder and found that 100mg of flibanserin taken daily was associated with statistically significant improvements in the number of satisfying sexual episodes per month. Studies also showed improvements in reported sexual desire over placebo and reduction in stress associated with sexual dysfunction.

In one manufacturer-sponsored randomized controlled trial published last year (n = 1,087), the results of which were submitted to the FDA, flibanserin was seen increasing satisfying sexual events per month by an average of 2.5, compared with 1.5 for placebo (J. Sex. Med. 2013;10:1807-15 [doi: 10.1111/jsm.12189]). Since the drug was first denied in June 2010 by an FDA advisory panel, the manufacturer, Sprout Pharmaceuticals, added 14 new clinical studies with data on more than 3,000 new patients to its resubmitted application. In total, more than 11,000 women have tried the drug and more than 5,000 subjects were enrolled in phase III trials.

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