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Flibanserin, sold under the trade name Addyi, is a medication approved for the treatment of pre-menopausal women with hypoactive sexual desire disorder (HSDD).
Development by Boehringer Ingelheim was halted in October 2010 following a negative evaluation by the U.S. Food and Drug Administration.
HSDD was recognized as a distinct sexual function disorder for more than 30 years, but was removed from the Diagnostic and Statistical Manual of Mental Disorders in 2013, and replaced with a new diagnosis called female sexual interest/arousal disorder (FSIAD).
1 Medical uses
2 Side effects
3 Mechanism of action
3.1 Activity profile
4 Society and culture
4.2 Approval process and advocacy
4.3 Physician and pharmacy certification
4.4 Advocacy groups
4.5 Acquisition by Valeant Pharmaceuticals
7 External links
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”.
The effectiveness of flibanserin was evaluated in three phase 3 clinical trials. Each of the three trials had two co-primary endpoints, one for satisfying sexual events (SSEs) and the other for sexual desire. Each of the 3 trials also had a secondary endpoint that measured distress related to sexual desire. All three trials showed that flibanserin produced an increase in the number of SSEs and reduced distress related to sexual desire. The first two trials used an electronic diary to measure sexual desire, and did not find an increase. These two trials also measured sexual desire using the Female Sexual Function index (FSFI) as a secondary endpoint, and an increase was observed using this latter measure. The FSFI was used as the co-primary endpoint for sexual desire in the third trial, and again showed a statistically significant increase.
Women’s overall feeling of improvement was small to none.
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 occurred after only 2 glasses of wine occurred in 17%).
Mechanism of action
Flibanserin acts as a full agonist in the frontal cortex and the raphe dorsalis, but only as a partial agonist in the CA3 region of the hippocampus
The proposed mechanism of action refers to the Kinsey dual control model of sexual response.
Society and culture
Flibanserin was originally developed as an antidepressant, before being repurposed for the treatment of HSDD.
Former proposed but abandoned trade names of flibanserin include Ectris and Girosa, and its former developmental code name was BIMT-17.
Current brand name is Addyi
Approval process and advocacy
On June 18, 2010, a federal advisory panel to the U.S. Food and Drug Administration (FDA) unanimously voted against recommending approval of flibanserin, citing an inadequate risk-benefit ratio. The Committee acknowledged the validity of hypoactive sexual desire as a diagnosis, but expressed concern with the drug’s side effects and insufficient evidence for efficacy, especially the drug’s failure to show a statistically significant effect on the co-primary endpoint of sexual desire.
Sprout responded to the FDA’s cited deficiencies and refiled the NDA in 2013. The submission included data from a new Phase 3 trial and several Phase 1 drug-drug interaction studies.
On June 4, 2015, the US FDA Advisory Committee, which includes the Bone, Reproductive, and Urologic Drugs Advisory Committee (BRUDAC) and the Drug Safety and Risk Management Advisory Committee (DSRM), recommended approval of the drug by 18–6, with the proviso that measures be taken to inform women of the drug’s side effects.
Physician and pharmacy certification
In the United States physicians and pharmacies dealing with flibanserin have to undergo a certification process, while patients need to submit a written agreement to abstain from alcohol.
Even the Score, a coalition of women’s group’s 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.
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, National Consumers League, and the American Sexual Health Association.
The approval was opposed by the National Women’s Health Network, the National Center for Health Research and Our Bodies Ourselves.
The Even the Score campaign was managed by Blue Engine Message & Media, a public relations firm, and received funding from Sprout.
Acquisition by Valeant Pharmaceuticals
On 20 August 2015 Valeant Pharmaceuticals and Sprout Pharmaceuticals announced that Valeant will acquire Sprout, on a debt-free basis, for approximately $1 billion in cash, plus a share of future profits based upon the achievement of certain milestones.
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.
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