Flibanserin, sold under the brand name Addyi, is a medication approved for the treatment of pre-menopausal women with hypoactive sexual desire disorder (HSDD).

All three trials showed that flibanserin produced an increase in the number of SSEs and reduced distress related to sexual desire.

The most commonly reported adverse events included dizziness, nausea, feeling tired, sleepiness, and trouble sleeping.

By modulating serotonin and dopamine activity in certain parts of the brain, flibanserin may improve the balance between these neurotransmitter systems in the regulation of sexual response.

In June 2010, a federal advisory panel to the US Food and Drug Administration (FDA) unanimously voted against recommending approval of flibanserin, citing an inadequate risk-benefit ratio.

Ahead of the votes, Boehringer Ingelheim had mounted a publicity campaign to promote the controversial disorder of "hypoactive sexual desire".

The letter cited several concerns, including the failure to demonstrate a statistical effect on the co-primary endpoint of sexual desire and overly restrictive entry criteria for the two Phase 3 trials.

The Agency agreed to call a new Advisory Committee meeting to consider whether the risk-benefit ratio of flibanserin was favorable after this additional data was obtained.

[34][35] On 18 August 2015, the FDA approved Addyi (Flibanserin) for the treatment of premenopausal women with low sexual desire that causes personal distress or relationship difficulties.

[36] Even the Score, a coalition of women's groups brought together by a Sprout consultant, actively campaigned for the approval of flibanserin.

[37] 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.

[45] The Even the Score campaign was managed by Blue Engine Message & Media, a public relations firm, and received funding from Sprout.

[48] 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;[49] and questions about the drug's efficacy and need.