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

Dr. Larkin explains this case of inequality.

woman in courtDid you know there are 23 FDA-approved treatments for either erectile dysfunction (ED) or low testosterone in men, yet 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 who feel the loss of an integral part of themselves. In fact, more women than men voice some form of sexual complaint when asked — 43 percent vs. 31 percent. Low sexual desire impacts more than just sex. It 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. Many women say they keenly feel the loss of desire, leaving them feeling disappointed, frustrated and inadequate.

What makes this all the more disappointing is that a novel drug shown in clinical trials to improve sex drive in women has been facing FDA approval difficulty. 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 this 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]). In trials, the most frequently reported adverse events associated with flibanserin were dizziness, fatigue and nausea. The FDA asked for more information before the agency could approve it for the U.S. market. But, the manufacturer, Sprout Pharmaceuticals, argues that the company has gone far above and beyond what is necessary to prove its treatment works and is necessary for many women.

Since the drug was first denied in June 2010 by an FDA advisory panel, the company added 14 new clinical studies with data on more than 3,000 new patients to its re-submitted application. In total, more than 11,000 women have tried the drug and more than 5,000 subjects were enrolled in phase III trials, which marks the final stage of efficacy and safety testing.

On Dec. 3, the FDA accepted Sprout Pharmaceuticals appeal and is expected to rule in the first quarter of 2014. The appeals process isn’t guaranteed. Out of 17 appeals the FDA considered in 2012, 14 were denied, according to agency statistics.

If men are given 23 FDA-approved treatments for either erectile dysfunction or low testosterone to help improve their sex lives, shouldn’t women be given at least one?

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