Objective: This study aimed to assess the efficacy and safety of flibanserin, a serotonin receptor 1A agonist/serotonin receptor 2A antagonist, in postmenopausal women with hypoactive sexual desire disorder (HSDD).
Methods: Naturally postmenopausal women with HSDD received flibanserin 100 mg once daily at bedtime (n = 468) or placebo (n = 481) for 24 weeks. Co–primary endpoints were changes from baseline to week 24 in the number of satisfying sexual events (SSEs) across 28 days and in the Female Sexual Function Index (FSFI) desire domain score. Secondary endpoints included change from baseline in Female Sexual Distress Scale—Revised (FSDS-R) Item 13 score (which assesses distress due to low sexual desire), FSDS-R total score, and FSFI total score. The Patient Benefit Evaluation was asked on treatment discontinuation.
Results: There were significant improvements with flibanserin versus placebo in the mean (SE) changes in the number of SSEs (1.0 [0.1] vs 0.6 [0.1]), FSFI desire domain score (0.7 [0.1] vs 0.4 [0.1]), FSDS-R Item 13 score (−0.8 [0.1] vs −0.6 [0.1]), FSDS-R total score (−8.3 [0.6] vs −6.3 [0.6]), and FSFI total score (4.2 [0.4] vs 2.7 [0.4]; all P < 0.01). More women on flibanserin (37.6%) than women on placebo (28.0%) reported experiencing meaningful benefits from the study medication on treatment discontinuation. The most frequent adverse events associated with flibanserin were dizziness, somnolence, nausea, and headache.
Conclusions: In naturally postmenopausal women with HSDD, flibanserin, compared with placebo, has been associated with improvement in sexual desire, improvement in the number of SSEs, and reduced distress associated with low sexual desire, and is well tolerated.
From the 1Women’s Health and Research Consultants, George Washington University School of Medicine, Washington, DC; 2University Hospitals Case Medical Center, Cleveland, OH; 3Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT; and 4Boehringer Ingelheim Pharma GmbH and Co KG, Ingelheim, Germany.
Received December 24, 2012; revised and accepted September 19, 2013.
The authors were responsible for all content and editorial decisions, were involved at all stages of manuscript development, and approved the final version.
Funding/support: The study reported in this article was funded by the previous owner of the flibanserin program and initiator of the study, Boehringer Ingelheim (ClinicalTrials.gov registry number: NCT00996372). Medical writing assistance, supported financially by Boehringer Ingelheim, was provided by Isobel Lever, PhD, and Wendy Morris, MSc, of Fleishman-Hillard Group Limited (London, UK) during the preparation of this manuscript. Sprout Pharmaceuticals Inc has acquired flibanserin and is now fully responsible for future development.
Financial disclosure/conflicts of interest: In the 12 months before the final submission of this article, J.A.S. has served as a consultant to or on the advisory boards of Abbott Laboratories/AbbVie Inc, Agile Therapeutics Inc, Amgen Inc, Apotex Inc, Ascend Therapeutics, BioSante, Depomed Inc, Everett Laboratories Inc, Intimina by Lelo Inc, Lupin Pharmaceuticals, TherapeuticsMD, Meda Pharmaceuticals Inc, Merck and Co Inc, Novartis Pharmaceuticals Corp, Noven Pharmaceuticals Inc, Novo Nordisk, Novogyne, Pfizer Inc, Shionogi Inc, Shippan Point Advisors LLC, Slate Pharmaceuticals Inc, Sprout Pharmaceuticals, Teva Pharmaceutical Industries Ltd, Warner Chilcott, and Watson Pharmaceutical Inc. He has received or is currently receiving grant/research support from Abbott Laboratories/AbbVie Inc, BioSante, EndoCeutics Inc, Novo Nordisk, Novogyn, Palatin Technologies, Teva Pharmaceutical Industries Ltd, and Warner Chilcott. He has served or is currently serving on the speaker’s bureaus of Amgen Inc, Eisai Inc, Merck and Co Inc, Novartis, Noven Pharmaceuticals Inc, Novo Nordisk, Novogyne, Shionogi Inc, Teva Pharmaceutical Industries Ltd, and Warner Chilcott. J.A.S. was the chief medical officer for Sprout Pharmaceuticals and holds stock options in the company. S.A.K. has served as a consultant to and/or advisory board member for Boehringer Ingelheim, The North American Menopause Society, Society for Assisted Reproductive Technologies, Sprout, Palatin, Emotional Brain, Trimel, Pfizer, Shionogi, BioSante, Apricus, and Novo Nordisk. She has been paid to give educational presentations by Boehringer Ingelheim, Medscape/WebMD, and Haymarket. She also holds stock/stock options in Viveve. V.H., M.G. Jr., and M.S. are employees of Boehringer Ingelheim. B.S. is a former employee of Boehringer Ingelheim.
Address correspondence to: James A. Simon, MD, George Washington University School of Medicine, Women’s Health & Research Consultants, 1850 M Street, NW, Washington, DC 20036. E-mail: firstname.lastname@example.org