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Bremelanotide for Hypoactive Sexual Desire Disorder: Contraceptive Subgroups Efficacy Analysis [15OP]

Clayton, Anita H. MD; Kingsberg, Sheryl PhD; Simon, James A. MD, CCD, NCMP, IF; Jordan, Robert BS; Williams, Laura MD, MPH; Krop, Julie MD

doi: 10.1097/01.AOG.0000559073.00208.e2
Friday, May 3, 2019
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INTRODUCTION: Bremelanotide, an investigational new drug, demonstrated efficacy in premenopausal women with hypoactive sexual desire disorder (HSDD) in the RECONNECT studies. In this analysis, bremelanotide efficacy was investigated across hormonal contraceptive subgroups.

METHODS: RECONNECT comprised two replicate, phase 3, double-blind, randomized, placebo-controlled, IRB-approved studies. Subjects self-administered bremelanotide 1.75 mg or placebo subcutaneously for 24 weeks, using an autoinjector pen on demand prior to sexual activity. Subjects were evaluated (“yes” and “no” subgroups) based on concurrent use of hormonal contraceptives (including oral contraceptives and other estrogen-containing products). Efficacy was assessed using RECONNECT co-primary endpoints: change from baseline to end-of-study (EOS) for Female Sexual Function Index-desire domain (FSFI-D) and Female Sexual Distress Scale-Desire/Arousal/Orgasm (FSDS-DAO) Item 13 scores.

RESULTS: In the integrated population (N=1202), difference in mean change in FSFI-D and FSDS-DAO Item 13 from baseline to EOS (bremelanotide-placebo) was 0.35 and -0.33, respectively (P<.0001 for both endpoints). In the study, 18.4% (N=221) concurrently used hormonal contraceptives (“yes” subgroup). Subjects in "no" subgroup who were treated with bremelanotide (N=484) showed a statistically significant increase in FSFI-D relative to placebo (N=497; 0.39, P<.0001). Those in "yes" subgroup showed a numerical difference in favor of bremelanotide (N=112) versus placebo (N=109; 0.19, P=.1557). Change from baseline to EOS in FSDS-DAO Item 13 was statistically significant in favor of bremelanotide relative to placebo in both subgroups (-0.30 and -0.34; P=.0471 and P<.0001, respectively).

CONCLUSION: Independent of the type of contraceptive used, bremelanotide demonstrated improvements in sexual desire and related distress in premenopausal women with HSDD.

University of Virginia School of Medicine, Charlottesville, VA

Financial Disclosure: Anita Clayton disclosed the following—Alkermes: Consultant/Advisory Board—AMAG Pharmaceuticals, Inc.: Consultant/Advisory Board; Axsome: Grants; Endoceutics: Grants; Euthymics: Ownership Interest includes stock, stock options, patent or other intellectual property; Ivix: Consultant/Advisory Board; Janssen: Grants; Palatin Technologies, Inc.: Consultant/Advisory Board, Grants; S1 Biopharma: Consultant/Advisory Board, Ownership Interest includes stock, stock options, patent or other intellectual property; Sage: Grants; Sprout: Consultant/Advisory Board; Takeda: Consultant/Advisory Board, Grants; Valeant Pharmaceuticals: Consultant/Advisory Board. Sheryl Kingsberg disclosed the following—AMAG Pharmaceuticals, Inc.: Consultant/Advisory Board; Dare Bioscience: Consultant/Advisory Board; Duchesnay USA: Consultant/Advisory Board; Emotional Brain: Consultant/Advisory Board; Endoceutics: Consultant/Advisory Board; Ivix: Consultant/Advisory Board; Lupin/Symbiomix: Consultant/Advisory Board; Materna: Consultant/Advisory Board; Nuelle: Consultant/Advisory Board; Palatin Technologies, Inc.: Consultant/Advisory Board; Pfizer: Consultant/Advisory Board; Shionogi Inc.: Consultant/Advisory Board; SST: Consultant/Advisory Board; TherapeuticsMD: Consultant/Advisory Board; Valeant Pharmaceuticals: Consultant/Advisory Board; Vieve: Ownership Interest includes stock, stock options, patent or other intellectual property; James Simon disclosed the following—Abbvie, Inc.: Consultant/Advisory Board, Speaker/Honoraria includes speakers bureau, symposia, and expert witness, Grants/Research Funding; Agile Therapeutics: Grants/Research Funding; Allergan, plc: Consultant/Advisory Board, Grants/Research Funding; AMAG Pharmaceuticals, Inc.: Consultant/Advisory Board, Speaker/Honoraria includes speakers bureau, symposia, and expert witness; Amgen: Consultant/Advisory Board; Ascend Therapeutics: Consultant/Advisory Board; Bayer Healthcare LLC.,: Grants/Research Funding; Bayer HealthCare Pharmaceuticals Inc.: Consultant/Advisory Board; CEEK Enterprises, LLC.: Consultant/Advisory Board Covance, Inc.: Consultant/Advisory Board; Dare Bioscience: Consultant/Advisory Board; Dornier MedTech: Grants/Research Funding; Duchesnay USA: Consultant/Advisory Board; Endoceutics, Inc.: Grants/Research Funding; GTx, Inc.: Grants/Research Funding; Hologic Inc.: Consultant/Advisory Board, Grants/Research Funding; KaNDy Therapeutics Ltd.: Consultant/Advisory Board; Millendo Therapeutics, Inc.: Consultant/Advisory Board; Mitsubishi Tanabe Pharma Development America, Inc.: Consultant/Advisory Board; Myovant Sciences: Grants/Research Funding; NeRRe Therapeutics Ltd.: Consultant/Advisory Board; New England Research Institute, Inc.: Grants/Research Funding; Novo Nordisk: Speaker/Honoraria includes speakers bureau, symposia, and expert witness; ObsEva SA: Consultant/Advisory Board, Grants/Research Funding; Palatin Technologies, Inc.: Grants/Research Funding; Radius Health, Inc.: Consultant/Advisory Board; Sanofi S.A.: Consultant/Advisory Board; Sebela Pharmaceuticals, Inc.: Consultant/Advisory Board; Sermonix Pharmaceuticals, Inc.: Ownership Interest includes stock, stock options, patent or other intellectual property; Shionogi Inc.: Consultant/Advisory Board, Speaker/Honoraria includes speakers bureau, symposia, and expert witness; Symbio Research, Inc.: Grants/Research Funding; Symbiotec Pharmalab: Consultant/Advisory Board; TherapeuticsMD: Consultant/Advisory Board, Speaker/Honoraria includes speakers bureau, symposia, and expert witness, Grants/Research Funding; Tissue Genesis: Grants/Research Funding; Valeant Pharmaceuticals: Consultant/Advisory Board, Speaker/Honoraria includes speakers bureau, symposia, and expert witness Viveve Medical: Grants/Research Funding. Robert Jordan disclosed the following—Palatin Technologies, Inc.: Employment, Ownership Interest includes stock, stock options, patent or other intellectual property. Laura Williams disclosed the following—AMAG Pharmaceuticals, Inc.: Employment, Ownership Interest includes stock, stock options, patent or other intellectual property. Julie Krop: AMAG Pharmaceuticals, Inc.: Employment, Ownership Interest includes stock, stock options, patent or other intellectual property.

© 2019 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.