#157 Flibanserin: Feeling frisky or falling over?

CLINICAL QUESTION

QUESTION CLINIQUE

Does flibanserin improve sexual desire and the number of satisfying sexual episodes for women?

BOTTOM LINE

RÉSULTAT FINAL

Flibanserin results in ~7% improvement in desire and 0.4-1 additional “satisfying” sexual event per month. However, it is also associated with adverse events like dizziness or somnolence for one in 10-15 women. Concerns regarding hypotension, syncope, and interactions with commonly used drugs (particularly alcohol) are worrisome and require further research.

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EVIDENCE

DONNÉES PROBANTES

Four double-blind randomized controlled trials of 1,581,¹ 880,² and 1,087³ premenopausal women and 949⁴ postmenopausal women with Hypoactive Sexual Desire Disorder. Flibanserin (versus placebo) demonstrated:
- Statistically significant increase in “satisfying” sexual events: 0.4-1/28 days.^3,4
- No increase daily sexual desire.^1,2
- Increase in Female Sexual Function Index-Desire domain:
  - 0.3-0.4 on scale of 1.2-6.0.^1-4
- Number Needed to Harm (NNH) for any investigator defined adverse event =5, dizziness =10-15, somnolence =10-14, nausea =13-25, fatigue =29-42.³
- US Food and Drug Administration (FDA) review (including unpublished data)⁵ reports NNH for any serious adverse event =250, syncope =500.
- Study limitations:
  - Strict exclusion criteria (example no benzodiazepines, sleep aids, narcotics, antidepressants).^1-4
  - Change in primary outcome to find statistical significance.^3,4
  - Poor adverse events and drug interactions reporting.^1,2

Context:

FDA assessed phase 1-3 studies with 6,439 women reports safety concerns regarding hypotension, syncope, and somnolence, worsened with alcohol, oral contraceptives, and antifungals (among others).⁶
Among 25 patients (23 male) given both alcohol (0.4g/kg) and flibanserin, 17% developed hypotension and/or syncope requiring intervention.⁶
Following the second FDA rejection, an advocacy campaign entitled “Even the Score” (sponsored in part by flibanserin manufacturers) claimed the FDA was exhibiting gender bias by rejecting flibanserin.^7,8
FDA approved flibanserin for Hypoactive Sexual Desire Disorder on its third application, with a risk mitigation strategy including alcohol contraindication and further research.^6,8,9
Flibanserin has not yet been approved for use in Canada.

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February 29, 2016

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Author(s)

Auteur(s)

Christina Korownyk MD CCFP
Robert Webster MD CCFP

1. Thorp J, Simon J, Dattani D, et al. J Sex Med. 2012 Mar; 9(3):793-804.

2. Derogatis LR, Komer L, Katz M, et al. J Sex Med. 2012 Apr; 9(4):1074-85.

3. Katz M, DeRogatis LR, Ackerman R, et al. J Sex Med. 2013 Jul; 10(7):1807-15.

4. Simon JA, Kingsberg SA, Shumel B, et al. Menopause. 2014 Jun; 21(6):633-40.

5. FDA Briefing Document. Joint Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) and the Drug Safety and Risk Management (DSaRM) Advisory Committee. June 4, 2015. Available at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DrugSafetyandRiskManagementAdvisoryCommittee/UCM449088.pdf. Last accessed January 19, 2016.

6. Centre for Drug Evaluation and Research. Risk Assessment and Risk Mitigation Review(s) Available at: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/022526Orig1s000RiskR.pdf. Last accessed January 19, 2016.

7. Even the Score [website]. http://www.eventhescore.org. Last accessed January 19, 2016.