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flibanserin (Addyi, Girosa)

Indications: - hypoactive sexual desire disorder in premenopausal women Contraindications: - avoid alcohol within 2 hours of flibanserin (Addyi) Dosage: - PO QHS Pharmacokinetics: - metabolized by CYP3A4 Adverse effects: - syncope - hypotension Drug interactions: - alcohol use within 2 hours may increase risk of hypotension & syncope - CYP3A4 inhibitors including hormonal contraceptives & alcoholic beverages [1] Mechanism of action: - 5-hydroxytryptamine 1A receptor agonist - 5-hydroxytryptamine 2A receptor antagonist - number of satisfying sexual events per month increases by 0.5 from a baseline of 2.5/month [4] - mean increase in a sexual desire intensity score is 1.6 on an 84 point scale - mean increase in desire on the Female Sexual Function Index is 0.3 (scale of 1.2-6.0) [4] Notes: - FDA-approved Aug 2014 [1,2,3] - twice, the panel has declined to recommend the drug because the treatment effect was not much larger than placebo

General

endocrine agent heterocyclic compound, 2 rings amine amide anhydride

Database Correlations

PUBCHEM correlations

References

  1. FDA Briefing Document. June 4, 2015 Joint Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) and the Drug Safety and Risk Management (DSaRM) Advisory Committee. NDA 022526 Flibanserin (Proposed trade name: Addyi) http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DrugSafetyandRiskManagementAdvisoryCommittee/UCM449088.pdf
  2. FDA News Release. August 18, 2015 FDA approves first treatment for sexual desire disorder. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm458734.htm
  3. Joffe HV, Chang C, Sewell C et al Perspective. FDA Approval of Flibanserin - Treating Hypoactive Sexual Desire Disorder. N Engl J Med 2016; 374:101-104. January 14, 2016 PMID: 26649985 http://www.nejm.org/doi/full/10.1056/NEJMp1513686
  4. Jaspers L, Feys F, Bramer WM et al Efficacy and Safety of Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Women. A Systematic Review and Meta-Analysis. JAMA Intern Med. Published online February 29, 2016 PMID: 26927498 http://archinte.jamanetwork.com/article.aspx?articleid=2497781 - Woloshin S, Schwartz LM US Food and Drug Administration Approval of Flibanserin. Even the Score Does Not Add Up. JAMA Intern Med. Published online February 29, 2016 PMID: 26926770 http://archinte.jamanetwork.com/article.aspx?articleid=2497778
  5. FDA News Release. April 11l 2019 FDA orders important safety labeling changes for Addyi. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm635847.htm