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Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder

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Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder Sexuality: Original Research 12/02/2019 on PaiGAmD1iBWIto1wobQLbbXEjpGPprd9Qk+dUdz/v66UbpPNth/EIuMmALaG/DFiVRtbJMTKzxT7pGXPxSWTRbUkiaO2A8oxvG33gXZRvBgACeRKNWLCWBoBDAXHORnCvjUrnLjhAuOkIKwgoF5A6cj8xFFfGTIlYMGuqZlTBYflBTBDsh1zBg== by https://journals.lww.com/greenjournal from Downloaded Downloaded Bremelanotide for the Treatment of from Hypoactive Sexual Desire Disorder https://journals.lww.com/greenjournal Two Randomized Phase 3 Trials Sheryl A. Kingsberg, PhD, Anita H. Clayton, MD, David Portman, MD, Laura A. Williams, MD, MPH, Julie Krop, MD, Robert Jordan, BS, Johna Lucas, MD, and James A. Simon, MD by PaiGAmD1iBWIto1wobQLbbXEjpGPprd9Qk+dUdz/v66UbpPNth/EIuMmALaG/DFiVRtbJMTKzxT7pGXPxSWTRbUkiaO2A8oxvG33gXZRvBgACeRKNWLCWBoBDAXHORnCvjUrnLjhAuOkIKwgoF5A6cj8xFFfGTIlYMGuqZlTBYflBTBDsh1zBg== OBJECTIVE: To evaluate the safety and efficacy of treatment with bremelanotide or placebo. Sample size bremelanotide for the treatment of premenopausal was estimated based on simulations from key endpoints women with hypoactive sexual desire disorder. in patients with hypoactive sexual desire disorder from METHODS: Two identical phase 3, randomized, double- a prior trial. Coprimary efficacy endpoints were change blind, placebo-controlled, multicenter clinical trials (RE- from baseline to end-of-study in the Female Sexual CONNECT) evaluated the safety and efficacy of breme- Function Index–desire domain score and Female Sexual lanotide 1.75 mg administered subcutaneously as needed Distress Scale–Desire/Arousal/Orgasm item 13. in premenopausal women with hypoactive sexual desire RESULTS: Study 301 began on January 7, 2015, and disorder. Patients were randomized 1:1 to 24 weeks of concluded on July 26, 2016. Study 302 began on January 28, 2015, and concluded on August 4, 2016. Of the 1,267 See related editorial on page 897. women randomized, 1,247 and 1,202 were in the safety From the University Hospitals Cleveland Medical Center, Cleveland, Ohio; for AMAG Pharmaceuticals, Inc.; he is an employee and stockholder of Sermonix University of Virginia, Charlottesville, Virginia; Sermonix Pharmaceuticals, Pharmaceuticals. Dr. Williams and Dr. Krop are employees and stockholders of Columbus, Ohio; AMAG Pharmaceuticals, Inc., Waltham, Massachusetts; AMAG Pharmaceuticals, Inc. (the licensee of bremelanotide). Mr. Jordan is Vice Palatin Technologies, Inc., Cranbury, New Jersey; and George Washington President, Clinical Operations and Project Management, and a stockholder of University and IntimMedicine Specialists, Washington, DC. Palatin Technologies, Inc. (the sponsor of the trial). He has a BS in Biology The RECONNECT studies were sponsored by Palatin Technologies, Inc., the and has worked in clinical development for over 20 years. He led the Palatin innovator of bremelanotide. Editorial support in the preparation of this manu- team in the development of bremelanotide (clinical, regulatory, etc.) since 2007, script was provided by Phase Five Communications, supported by AMAG Phar- including having a very significant role in designing the phase 3 studies, conduct of maceuticals, Inc., the licensee of bremelanotide. the studies, and analysis of the data. Dr. Lucas was an employee of Palatin Technologies, Inc. at the time of the study. She has no remaining financial interests Presented at the ISSWSH Annual Meeting in Atlanta, Georgia, February 23–26, 2017. in Palatin Technologies. She was the medical lead for the entire trial. She was the The authors thank all participants in these studies, their families, and personnel physician who ran the trial and provided safety evaluation and analysis for all at all study sites. adverse events as they occurred during the trial. She was also responsible for aggregate assessment of the adverse event database. She was the physician who ’ Each author has confirmed compliance with the journal s requirements for authorship. provided medical information to the DSMB during the trial. Dr. Simon has served Corresponding author: Sheryl A. Kingsberg, PhD, Division of Behavioral on advisory boards or has been a consultant for AbbVie, Allergan, AMAG Phar- Medicine, MacDonald Women’s Hospital, University Hospitals Cleveland Med- maceuticals, Inc., Amgen, Ascend Therapeutics, Azure Biotech, Bayer HealthCare ical Center, Cleveland, OH; email: [email protected]. Pharmaceuticals, Inc., CEEK Enterprises, Covance Inc., Daré Bioscience, Duch- Financial Disclosure esnay, Hologic Inc., KaNDy/NeRRe Therapeutics Ltd., Millendo, Mitsubishi Ta- nabe Pharma, ObsEva, Radius Health, Sanofi, Sebela, Sermonix, Shionogi, Dr. Kingsberg has served on advisory boards or has been a consultant for AMAG Symbiotec Pharmalab, TherapeuticsMD, and Valeant. He has also served on Pharmaceuticals, Inc., Daré Bioscience, Duchesnay, Emotional Brain, Valeant, the speaker’s bureau for AbbVie, AMAG Pharmaceuticals, Inc., Duchesnay, Novo Endoceutics, Ivix, Palatin Technologies, Inc., Pfizer, Shionogi, Materna, Nuelle, Nordisk, Shionogi, and Valeant. He has received grants/research funding from Mitsubishi Tanaka North America, TherapeuticsMD, SST, and Lupin/Symbio- AbbVie, Allergan, Agile Therapeutics, Bayer Healthcare LLC, Dornier MedTech, mix. She has stock options in Viveve Medical. Dr. Clayton has served on advisory Endoceutics Inc., GTx Inc., Hologic Inc., Myovant Sciences, New England boards or has been a consultant for Acadia, Alkermes, Allergan, AMAG Pharma- Research Institutes, ObsEva, Palatin Technologies, Inc., Symbio Research, Ther- ceuticals, Inc., Fabre Kramer, Lundbeck, Palatin Technologies, Inc., S1 Biophar- apeuticsMD, Tissue Genesis, and Viveve Medical. He owns stock in Sermonix. ma, Sage Therapeutics, Sprout, and Takeda. She has received grants from Endoceutics, Inc., Janssen, Sage Therapeutics, and Takeda. In addition, she has © 2019 The Author(s). Published by Wolters Kluwer Health, Inc. This is an received royalties and/or owns the copyright to works published by Ballantine open-access article distributed under the terms of the Creative Commons Books/Random House and Guilford Publications, and the Changes in Sexual Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), on 12/02/2019 Functioning Questionnaire. She has shares or restricted stock units in Euthymics where it is permissible to download and share the work provided it is properly and S1 Biopharma. Dr. Portman has served on advisory boards or has been cited. The work cannot be changed in any way or used commercially without a consultant to AMAG Pharmaceuticals, Inc., Palatin Technologies, Inc., permission from the journal. Endoceutics, Valeant Pharmaceuticals, and Sprout, and is on the speaker’s bureau ISSN: 0029-7844/19 VOL. 134, NO. 5, NOVEMBER 2019 OBSTETRICS & GYNECOLOGY 899 and efficacy (modified intent-to-treat) populations, endogenous neuropeptide a-melanocyte-stimulating respectively. Most participants were white (85.6%), from hormone with high affinity for the melanocortin-4 U.S. sites (96.6%), and had a mean age of 39 years. From receptor.10 Preclinical studies suggest that bremelano- baseline to end-of-study, women taking bremelanotide tide acts on physiologic and neurobiologic compo- had statistically significant increases in sexual desire nents of female sexual function by modulating P, P, (study 301: 0.30, .001; study 302: 0.42, .001; inte- neurotransmitter pathways involved in sexual desire P, grated studies 0.35, .001) and statistically significant and arousal in women with hypoactive sexual desire reductions in distress related to low sexual desire (study disorder.8 2 P, 2 P5 301: 0.37, .001; study 302: 0.29, .005; integrated A phase 2b, randomized, double-blind, placebo- studies 20.33, P,.001) compared with placebo. Patients controlled, dose-finding trial (NCT01382719) was taking bremelanotide experienced more nausea, flush- conducted with 397 premenopausal women with ing, and headache (10% or more in both studies) com- hypoactive sexual desire disorder, female sexual pared with placebo. arousal disorder, or both. Self-administered subcuta- CONCLUSIONS: Both studies demonstrated that bre- neous bremelanotide, taken as needed for up to 12 melanotide significantly improved sexual desire and weeks, showed dose-responsive improvements in related distress in premenopausal women with hypoac- desire, arousal, and associated distress, as well as tive sexual desire disorder. The safety profile was favor- increases in the number of satisfying sexual events able. Most treatment-emergent adverse events were related to tolerability and the majority were mild or compared with placebo. The 1.75 mg dose of breme- moderate in intensity. lanotide was selected for phase 3 studies based on optimal efficacy and an acceptable safety profile.11 CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, After discussion with the FDA, two separate, NCT02333071 (study 301) and NCT02338960 (study 302). identically designed phase 3 clinical trials were con- FUNDING SOURCE: Palatin Technologies, Inc., and ducted as per their recommendation. The current AMAG Pharmaceuticals, Inc. report details the individual study results and the (Obstet Gynecol 2019;134:899–908) integrated data from the core phase 3 RECONNECT DOI: 10.1097/AOG.0000000000003500 pivotal studies, designed to evaluate the safety and efficacy of bremelanotide in premenopausal women emale sexual dysfunction refers to a heterogenous with acquired, generalized hypoactive sexual desire F group of sexual disorders, including difficulties disorder. with desire, interest, arousal, orgasm, or pain (dyspar- eunia) that may
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