Flibanserin

Flibanserin, sold under the brand name Addyi, is a medication approved for the treatment of pre-menopausal women with hypoactive sexual desire disorder (HSDD). The medication increases the number of satisfying sexual events per month by about one-half over the placebo from a starting point of about two to three. The certainty of the estimate is low. The side effects of dizziness, sleepiness, and nausea occur about three to four times more often.

Medical Uses

Flibanserin is used for hypoactive sexual desire disorder among women. Those receiving flibanserin report a 0.5 increase compared to placebo in the number of times they had "satisfying sexual events". In those on flibanserin, it rose from 2.8 to 4.5 times a month while women receiving placebo reported also an increase of "satisfying sexual events" from 2.7 to 3.7 times a month. The onset of the flibanserin effect was seen from the first timepoint measured after 4 weeks of treatment and maintained throughout the treatment period.

Side Effects

Adverse events are more common among women taking flibanserin. The majority of adverse events were mild to moderate. The most commonly reported adverse events included dizziness, nausea, feeling tired, sleepiness, and trouble sleeping. Drinking alcohol while on flibanserin may result in severely low blood pressure (low blood pressure that produced symptoms after two glasses of wine occurred in 17%).

Reception

The initial response since the 2015 introduction of flibanserin to the U.S. market was slow with 227 prescriptions written during the first three weeks. The slow response may be related to a number of factors: physicians require about 10 minutes of online training to get certified; the medication has to be taken daily and costs about US$400 per month; and questions about the drug's efficacy and need. Prescriptions for the drug continue to be few with less than 4,000 being made as of February 2016.

Advocacy

Even the Score, a coalition of women's groups brought together by a Sprout consultant, actively campaigned for the approval of flibanserin. The campaign emphasized that several approved treatments for male sexual dysfunction exist, while no such treatment for women was available. The group successfully obtained letters of support from the President of the National Organization for Women, the editor of the Journal of Sexual Medicine, and several members of Congress.

Other organizations supporting the approval of flibanserin included the National Council of Women's Organizations, the Black Women's Health Imperative, the Association of Reproductive Health Professionals, the National Consumers League, and the American Sexual Health Association.

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