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#157 Flibanserin: Feeling frisky or falling over?


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


BOTTOM LINE
Flibanserin results in ~7improvement 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
  • 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 
    • Nincrease 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 =10-15somnolence =10-14nausea =13-25fatigue =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    • US Food and Drug Administration (FDA) review (including unpublished data)5 reports NNH for any serious adverse event =250, syncope =500.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 manufacturersclaimed 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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Author(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.

8. Moynihan R. BMJ. 2014 Oct 17; 349:g6246.

9. Joffe HV, Chang C, Sewell C, et al. N Engl J Med. 2016 Jan 14; 374(2):101-4.

Authors do not have any conflicts to disclose.