DOCSLIB.ORG

Let's Start a Conversation

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Let's Start a Conversation LET’S START A CONVERSATION Low Sexual Desire in Women LET’S START A CONVERSATION This educational activity is jointly providedVaginal by the North and Carolina Sexual Academy of Family Health Physicians at(NCAFP) Midlife and Spire Learning. This activity is supported by an educational funding donation provided by AMAG Pharmaceuticals, Inc. LET’S START A CONVERSATION Low Sexual Desire in Women PROGRAM OVERVIEW A lack of interest in sex, or decreased desire, is a common female sexual problem that often goes unrecognized. Hypoactive sexual desire disorder (HSDD) is characterized by diminished feelings of sexual interest or desire that in turn causes distress. HSDD is estimated to affect from 10% to 46% of women in the United States, including women of all ages, regardless of menopausal status. This live meeting series will provide the latest updates in the diagnosis and management of HSDD to help improve the quality of life for your female patients, and will provide insights into: • Recognizing the prevalence ofLET’S HSDD andSTART barriers A toCONVERSATION care • Diagnosis using updated criteria, sexualVaginal health and Sexual communication Health at Midlife strategies, and validated screeners • The importance of identifying and treating common causes and comorbidities of low sexual desire • The range of nonpharmacologic, approved, and emerging pharmacologic and device-based therapies for HSDD TARGET AUDIENCE Family physicians LEARNING OBJECTIVES At the conclusion of this live activity, family physicians should be better able to: • Define hypoactive sexual desire disorder (HSDD) • Use communication strategies and screening tools to increase proactive discussions about sexual health as well as identification and diagnosis of female patients with HSDD • Recognize common causes and comorbidities of HSDD that should be treated before initiating targeted treatment for HSDD • Discuss efficacy and safety data for approved, emerging, and off-label treatments for HSDD LET’S START A CONVERSATION Low Sexual Desire in Women ACCREDITATION AND DISCLAIMER STATEMENTS This live activity, Let’s Start a Conversation: Low Sexual Desire in Women has been reviewed and is acceptable for up to 1.00 Prescribed credit(s) by the American Academy of Family Physicians. Physicians should claim only the credit commensurate with the extent of their participation in the activity. AMA/AAFP Equivalency: AAFP Prescribed credit is accepted by the American Medical Association as equivalent to AMA PRA Category 1 Credit(s)™ toward the AMA Physician’s Recognition Award. When applying for the AMA PRA, Prescribed creditLET’S earned START must be reportedA CONVERSATION as Prescribed credit, not as Category 1. Vaginal and Sexual Health at Midlife HOW TO RECEIVE CREDIT To receive credit for your participation in this educational activity: • Read the objectives and other introductory CME information • Complete the preassessment prior to the start of the activity • Participate in the HSDD presentation • Complete the postassessment and evaluation at the conclusion of the activity If you are seeking Prescribed credit, you must complete the postassessment and evaluation at the conclusion of the activity. LEVELS OF EVIDENCE Levels of evidence are provided for any patient care recommendations made during this presentation. Level A (randomized controlled trial/meta-analysis): High-quality, randomized controlled trial (RCT) that considers all important outcomes. High-quality meta-analysis (quantitative systematic review) using comprehensive search strategies Level B (other evidence): A well-designed, nonrandomized clinical trial. A nonquantitative systematic review with appropriate search strategies and well-substantiated conclusions. Includes lower-quality RCTs, clinical cohort studies, and case-controlled studies with nonbiased selection of study participants and consistent findings. Other evidence, such as high-quality, historical, uncontrolled studies, or well-designed epidemiologic studies with compelling findings, is also included Level C (consensus/expert opinion): Consensus viewpoint or expert opinion Each rating is applied to a single reference in the presentation, not the entire body of evidence on the topic. LET’S START A CONVERSATION Low Sexual Desire in Women OFF-LABEL STATEMENT The faculty intend to discuss/present information related to a non–FDA-approved or investigational use of a product/device, including the investigational use of testosterone for the treatment of HSDD. Participants should appraise the information presented critically and are encouraged to consult appropriate resources for any product or device mentioned in this activity. LET’S START A CONVERSATION Vaginal and Sexual Health at Midlife LET’S START A CONVERSATION Low Sexual Desire in Women FACULTY PRESENTERS Activity Chair: Lisa Larkin, MD, FACP, NMCP, IF Owner and President Lisa Larkin, MD, and Associates Founder & CEO Ms.Medicine Cincinnati, OH LET’S START A CONVERSATION Dr Lisa Larkin is a board-certified internist,Vaginal businessand Sexual owner, Health and at entrepreneurMidlife practicing internal medicine and women’s health in both academic and private practice since 1991 in Cincinnati, Ohio. She received her medical degree from the Yale University School of Medicine in New Haven, Connecticut, and then completed an internal medicine residency with the University of Chicago Hospitals, Pritzker School of Medicine, in Chicago, Illinois. Dr Larkin is owner and President of Lisa Larkin, MD, and Associates, an independent multi-specialty internal medicine and women’s health Direct Primary Care practice, as well as founder and CEO of Ms.Medicine, a concierge women’s healthcare organization. Dr Larkin is also founder and Executive Director of the nonprofit Cincinnati Sexual Health Consortium, and serves as Director of Women’s Corporate Health for TriHealth. She formerly (2012-2016) served as Associate Professor and Division Director of Midlife Women’s Health at the University of Cincinnati (UC) College of Medicine and as Director of the UC Health Women’s Center. Dr Larkin is a Fellow of the American College of Physicians and the International Society for the Study of Women’s Sexual Health (ISSWSH), and is certified as a menopause clinician by the North American Menopause Society (NAMS). Additionally, she serves on the board of directors of ISSWSH and the board of trustees of NAMS. Dr Larkin is passionate about raising the standard of evidence-based care for women and devotes considerable time to women’s health advocacy efforts. Most recently, she launched a direct-to- consumer breast cancer risk assessment and prevention program. Considered a national expert in menopause management and sexual medicine, Dr Larkin is also well known as a clinician and community educator, publisher, lecturer, and expert media resource. Her work has led to publications in peer-reviewed journals such as Menopause, Mayo Clinic Proceedings, and OBG Management. Disclosure Statement: Advisory Board: AMAG Pharmaceuticals, Inc; Amgen Inc; Procter & Gamble Co; TherapeuticsMD, Inc Consultant: AMAG Pharmaceuticals, Inc; Amgen Inc; Procter & Gamble Co; TherapeuticsMD, Inc Speaker: AMAG Pharmaceuticals, Inc; Amgen Inc; Procter & Gamble Co; TherapeuticsMD, Inc LET’S START A CONVERSATION Low Sexual Desire in Women FACULTY PRESENTERS (CONT’D) Becky Lynn, MD, FACOG, IF Associate Professor of Obstetrics and Gynecology Director, Center for Sexual Health Saint Louis University Saint Louis, MO Dr Becky Lynn is Director of the Center for Sexual Health and an Associate Professor of Obstetrics and Gynecology at Saint Louis University in Missouri. She earned her medical degree from Georgetown University School ofLET’S Medicine START in Washington, A CONVERSATION DC, completed her residency in obstetrics and gynecology at Barnes-Jewish HospitalVaginal in andSaint Sexual Louis, Health and then at Midlifepracticed at the University of Missouri, Columbia, before joining the faculty of Saint Louis University in 2015. Dr Lynn is a Fellow of the International Society for the Study of Women’s Sexual Health (ISSWSH) and the American College of Obstetricians and Gynecologists (ACOG), as well as President of the Saint Louis Obstetrical and Gynecological Society. She is a certified sexual counselor, and completed her training at Sexual Medicine Associates in West Palm Beach, Florida. Currently, she is working towards her Master’s in Business Administration at the Richard A. Chaifetz School of Business of Saint Louis University. Dr Lynn’s research interests include vaginal treatments for genitourinary syndrome of menopause and the effects of cannabis on the sexual experience. She has spoken nationally and internationally on women’s sexual health, and is known for her patient/partner education YouTube channel that features monthly videos highlighting topics relating to sexual health and women’s health in general. She has also made several appearances in podcasts, television, radio, and print. Dr Lynn is a member of many professional societies, including the International Society for the Study of Vulvovaginal Disease, ACOG, ISSWSH, the International Society for the Study of Sexual Medicine, and the World Professional Association for Transgender Health. Her work has led to publications in peer-reviewed journals such as the Journal of Clinical Endocrinology and Metabolism and Sexual Medicine. Disclosure Statement: Speaker: AMAG Pharmaceuticals, Inc; Bausch Health Companies Inc (formerly Valeant Pharmaceuticals International, Inc); TherapeuticsMD, Inc;
Load more

Recommended publications
  • Uses of Bremelanotide in Therapy for Female Sexual
    (19) TZZ __T (11) EP 2 916 856 B1 (12) EUROPEAN PATENT SPECIFICATION (45) Date of publication and mention (51) Int Cl.: of the grant of the patent: A61K 9/00 (2006.01) A61K 38/12 (2006.01) 19.09.2018 Bulletin 2018/38 A61P 15/00 (2006.01) C07K 7/64 (2006.01) (21) Application number: 13851014.4 (86) International application number: PCT/US2013/068386 (22) Date of filing: 05.11.2013 (87) International publication number: WO 2014/071339 (08.05.2014 Gazette 2014/19) (54) USES OF BREMELANOTIDE IN THERAPY FOR FEMALE SEXUAL DYSFUNCTION VERWENDUNG VON BREMELANOTID IN DER THERAPIE VON WEIBLICHER SEXUELLER DYSFUNKTION UTILISATIONS DE BRÉMÉLANOTIDE DANS UNE THÉRAPIE DE DYSFONCTIONNEMENT SEXUEL FÉMININ (84) Designated Contracting States: • "Palatin Technologies Presents Positive Results AL AT BE BG CH CY CZ DE DK EE ES FI FR GB for Phase 2B Bremelanotide Female Sexual GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO Dysfunction Trial", PRNewswire , 8 November PL PT RO RS SE SI SK SM TR 2012 (2012-11-08), XP002757483, Retrieved from the Internet: (30) Priority: 05.11.2012 US 201261722511 P URL:http://www.palatin.com/investors/press 28.02.2013 US 201361770535 P -releases/ [retrieved on 2016-05-09] • ROSEN R C ET AL: "Evaluation of the safety, (43) Date of publication of application: pharmacokineticsand pharmacodynamic effects 16.09.2015 Bulletin 2015/38 of subcutaneously administered PT-141, a melanocortin receptor agonist, in healthy male (73) Proprietor: Palatin Technologies, Inc. subjects and in patients with an inadequate Cranbury NJ 08512 (US) response to Viagra(R)", INTERNATIONAL JOURNAL OF IMPOTENCE RESEARCH, (72) Inventors: STOCKTON, BASINGSTOKE, GB, vol.
    [Show full text]
  • Preclinical Effects of Melanocortins in Male Sexual Dysfunction
    International Journal of Impotence Research (2008) 20, S11–S16 & 2008 Nature Publishing Group All rights reserved 0955-9930/08 $30.00 www.nature.com/ijir Preclinical effects of melanocortins in male sexual dysfunction AM Shadiack1 and S Althof2 1Locus Pharmaceuticals, Blue Bell, PA, USA and 2The Center for Marital and Sexual Health of South Florida, West Palm Beach, FL, USA The neurobiology of sexual behavior involves the interrelationships between sex steroids and neurotransmitters that result in both central nervous system (CNS) effects and effects in the genitalia. Tools such as positron emission tomography (PET) and functional magnetic resonance imaging (fMRI) scanning can help determine what areas of the brain are activated under sexual stimulation. Our understanding of the role of various neurotransmitters, neurosteroids and other CNS-acting compounds is improving. The role of CNS-acting compounds such as dopamine agonists in the treatment of male sexual dysfunction is under active investigation. Melanocortins have CNS and peripheral roles in a wide variety of bodily functions. The melanocortin agonist bremelanotide appears to act in the CNS to promote erections in preclinical models, and may also stimulate behaviors that facilitate sexual activity beyond their erectogenic effects. International Journal of Impotence Research (2008) 20, S11–S16; doi:10.1038/ijir.2008.17 Keywords: erectile dysfunction; neuroanatomy; neurophysiology; CNS-acting agents; melanocortins; bremelanotide Introduction Neuroanatomy of male sexual response The neurobiology of sexual behavior involves the Sex and the brain interrelationships between sex steroids and neuro- Sexual arousal can now be studied with such transmitters that result in both central nervous sophisticated tools as PET (positron emission system (CNS) effects and effects in the genitalia.
    [Show full text]
  • Modi Dissertation 2012 Submitted To
    Distribution Agreement In presenting this thesis or dissertation as a partial fulfillment of the requirements for an advanced degree from Emory University, I hereby grant to Emory University and its agents the non-exclusive license to archive, make accessible, and display my thesis or dissertation in whole or in part in all forms of media, now or hereafter known, including display on the world wide web. I understand that I may select some access restrictions as part of the online submission of this thesis or dissertation. I retain all ownership rights to the copyright of the thesis or dissertation. I also retain the right to use in future works (such as articles or books) all or part of this thesis or dissertation. Signature: ________________________ ______________________ Meera Modi Date Identifying Novel Therapeutic Strategies for Enhancing Social Cognition Using Functional Animal Models By Meera Modi Doctor of Philosophy Graduate Division of Biological and Biomedical Science Neuroscience _________________________________________ Larry Young, PhD Advisor _________________________________________ Lisa Parr, PhD Committee Member _________________________________________ Diana Robins, PhD Committee Member _________________________________________ Randy Hall, PhD Committee Member _________________________________________ Kerry J. Ressler, MD/PhD Committee Member Accepted: _________________________________________ Lisa A. Tedesco, Ph.D. Dean of the James T. Laney School of Graduate Studies ___________________ Date Identifying Novel Therapeutic
    [Show full text]
  • Female Sexual Interest / Arousal Disorder
    Female Sexual Interest / See SSRI sexual dysfunction Arousal Disorder decision support Asse ss for me dica tions w hich Refer to appropriate SSRI may affect sexual function History of physical/sexual/emotional abuse Present psychosocial services other (i.e SSRI, TCA, contraceptives, and/or intimate partner violence? and agencies available Benzodiazepines, antipsychotics) in community Reassess need for medication and transition if Substance use Appropriate Evaluate for partner Obtain full medical/sexual/ disorder? Present See corresponding Sexual dysfunction psychosocial history decision support Comorbid psychiatric Present disorder present? Treat underlyingPresent Evaluate for non-gynecological cause and reassess medical etiology Commorbidity absent Evaluate for gynecological etiology Symptom Is duration greater than 6 months Symptom persistence and causing significant distre ss? persistence Yes Female with Sexual Inte re st Arousa l Disorder Asse ss a nd e sta blish treatment expectations a nd goals Behavior Modification: Lifestyle changes Psychotherapy: Body image Sexual therapy Consider Sleep hygiene Trailored intervention Couples therapy combination therapy Stress reduction Based on H&P Mindfulness Pelvic therapy Relationship building Sexual novelty Inadequate response Continue Psychotherapy and Behavior modification interventions Inadequate response Consider topical oils (i.e. Zestra) in addition to Bupropion Pharmacotherapy Inadequate response Buspirone is less studied, however, it may be useful in some circumstances Postmenopausal? Buspirone No Yes Consider testosterone Flibanserin therapy. Consider consultation Inadequate response Bremelanotide FEMALE SEXUAL INTEREST /AROUSAL DISORDER Bupropion XL Antidepressant DOSING: starting dose 150mg XL qAM. Increase after 1 week to 300mg XL Wellbutrin XL (dopamine and qAM. Target dose 300mg- 450mg XL qAM. Max dose 450mg XL qAM. norepinephrine uptake inhibitor) SIDE EFFECTS: (common) insomnia, nausea, agitation, tremor (rare, serious) seizures, especially in patients with a history of seizures or eating disorders.
    [Show full text]
  • Bremelanotide in HSDD Presented at the 22Nd Annual Fall Scientific Meeting of 1 2 2 2 3 Sexual Medicine Society of North America Anita H
    222 The Neurobiology and Efficacy of Bremelanotide in HSDD Presented at the 22nd Annual Fall Scientific Meeting of 1 2 2 2 3 Sexual Medicine Society of North America Anita H. Clayton, Johna Lucas, Robert Jordan, Carl Spana, James G. Pfaus November 3– 6, 2016 Scottsdale, AZ 1University of Virginia, Charlottesville, VA, USA; 2Palatin Technologies, Cranbury, NJ, USA; 3Concordia University, Montréal, Québec, Canada • Introduction Mechanism of Sexual and Reward Circuitry Rat Study Human Study — Decreased (less distress) both the total score and • These neurochemicals act on similar regions of the brain, • BMT’s downstream CNS effects of increasing arousal • Among premenopausal women with HSDD with or scores on the desire, arousal, and orgasm items of • Female sexual dysfunctions are classified as dysfunctions Sexual Response such as the medial preoptic area (mPOA) in the hypothalamus, and desire are thought to result from its action as a without FSAD, subcutaneous (SC) administration of the FSDS–Desire-Arousal-Orgasm measure. Mean of desire (eg, hypoactive sexual desire disorder [HSDD]), attention- and reward-related regions of the limbic system, MC-receptor agonist BMT 1.25 or 1.75 mg: (SE) change, –11.1 (12.0) vs –6.8 (13.6); BMT vs arousal (eg, female sexual arousal disorder [FSAD]), • Excitatory signals are regulated by dopamine (DA), placebo, respectively ( P=0.0014; Figure 7 )11 and the prefrontal cortex • Among female rats primed with estrogen and proges - — Significantly increased the number of sexually satisfying delay or absence of orgasm, or sexual pain (dyspareunia norepinephrine (NE), oxytocin, and the melanocortins 5,6 — Gamma aminobutyric acid projections help regulate DA terone or estrogen alone, BMT significantly increased events (SSEs) vs placebo when taken 45 minutes or vaginismus) 1 (MCs) Figure 7.
    [Show full text]
  • Conversations with Women About Female Sexual Dysfunction (FSD)
    235 Conversations With Women About Female Sexual Dysfunction (FSD) and Treatment With Bremelanotide Presented at the 22nd Annual Fall Scientific Meeting of 1 2 3 4 5 5 6 Sexual Medicine Society of North America Patricia E. Koochaki , Stanley Althof , Sheryl A. Kingsberg , Michael A. Perelman , Johna Lucas , Robert Jordan , Dennis A. Revicki November 3– 6, 2016 Scottsdale, AZ 1PEK Market Research, Inc., Cincinnati, OH, USA; 2Case Western Reserve University School of Medicine, Cleveland, OH, USA; 3University Hospitals Case Medical Center, Cleveland, OH, USA; 4Weill Cornell Medical College, New York, NY, USA; 5Palatin Technologies, Cranbury, NJ, USA; Evidera, Bethesda, MD, USA • Recognizing There Was a Problem Partner and Relationship Effects Physical Effects of BMT Sexual Satisfaction Increased Summary of Benefits That Women With HSDD With/Without Introduction Results Decreased Arousal During the interviews, women described how they Partner Blamed Himself • About three-quarters of all participants reported experiencing Approximately two-thirds of participants taking 1.25 and 1.75 mg Female sexual dysfunctions (FSD) include a Pre-Study: Conceptualizing and Explaining Why began to recognize they were experiencing sexual “There were a couple of times where he did blame himself. He physical effects from BMT of BMT reported an improvement in sexual satisfaction. range of distressing, multifactorial conditions, They Experienced FSD difficulties that required intervention. thought something was wrong with him.” • Nine of 10 women taking the 1.75-mg dose of BMT reported “A positive way …I think it restored or rebuilt what [sexual such as dysfunctions of sexual interest/desire, • Most women were unaware that FSD is a recognized “Because for a young man our age, he’s thinking like, it must be me.
    [Show full text]
  • VYLEESI Is Not These Highlights Do Not Include All the Information Needed to Use Recommended in Patients at High Risk for Cardiovascular Disease
    HIGHLIGHTS OF PRESCRIBING INFORMATION treatment and ensure blood pressure is well-controlled. VYLEESI is not These highlights do not include all the information needed to use recommended in patients at high risk for cardiovascular disease. (5.1) VYLEESI™ safely and effectively. See full prescribing information for • Focal hyperpigmentation: Reported by 1% of patients who received up to 8 VYLEESI doses per month, including involvement of the face, gingiva and breasts. Higher risk in patients with darker skin and with daily dosing. Resolution VYLEESI (bremelanotide injection), for subcutaneous use was not confirmed in some patients. Consider discontinuing VYLEESI if Initial U.S. Approval: 2019 hyperpigmentation develops. (5.2) • Nausea: Reported by 40% of patients who received up to 8 monthly doses, ----------------------------INDICATIONS AND USAGE--------------------------­ requiring anti-emetic therapy in 13% of patients and leading to premature VYLEESI is a melanocortin receptor agonist indicated for the treatment of discontinuation for 8% of patients. Improved for most patients with the premenopausal women with acquired, generalized hypoactive sexual desire second dose. Consider discontinuing VYLEESI or initiating anti-emetic disorder (HSDD) as characterized by low sexual desire that causes marked therapy for persistent or severe nausea. (5.3) distress or interpersonal difficulty and is NOT due to: • A co-existing medical or psychiatric condition, -------------------------------ADVERSE REACTIONS----------------------------­ • Problems with the relationship, or Most common adverse reactions (incidence > 4%) are nausea, flushing, • The effects of a medication or drug substance (1). injection site reactions, headache, and vomiting. (6.1) Limitations of Use (1): To report SUSPECTED ADVERSE REACTIONS, contact AMAG • Not indicated for treatment of HSDD in postmenopausal women or in men.
    [Show full text]
  • Estimulos Para Aumentar Estimulos Para Aumentar La Respuesta Sexual
    ESTIMULOS PARA AUMENTAR LA RESPUESTA SEXUAL FEMENINA Dr. Santiago Palacios Instituto Palacios, Salud y Medicina de la Mujer Chairman of CAMS (Council of Affiliated Menopause Societies) President of SIBOMM (Ibero American Society of Osteology and Mineral Metabolism) Antonio Acuña, 9 - 28009 Madrid Teléfono 91 578 05 17 E-mail: [email protected] www.institutopalacios.com www.institutopalacios.com Diapositivas / Slides CONTENIDO • ESTUPEFACTO • QUÉ ES LA RESPUESTA SEXUAL FEMENINA • CONOCER LA RESPUESTA SEXUAL • QUÉ TENEMOS • QUÉ SE ESTÁ HACIENDO PARA EL FUTURO * DOCTOR, ACUDO A USTED YA QUE ES ESPECIALISTA EN ESTE CAMPO, PORQUE DESEO AUMENTAR MI RESPUESTA SEXUAL CONSULTA MÉDICA: ¿QUÉ? ¿QUÉ LE DIGO? ¿QUÉ HAGO? CONTENIDO • ESTUPEFACTO • QUÉ ES LA RESPUESTA SEXUAL FEMENINA • CONOCER LA RESPUESTA SEXUAL • QUÉ TENEMOS • QUÉ SE ESTÁ HACIENDO PARA EL FUTURO * Ciclo de respuesta sexual femenina: Modelo lineal • En 1966, Masters y Johnson introdujeron el primer modelo de la función sexual femenina. Propusieron un modelo lineal de sexualidad para mujeres consistente en cuatro etapas: excitación, meseta, orgasmo y resolución. • Diferentes mujeres diferentes patrones de respuesta • Misma mujer diferente patrón de respuesta en diferentes ocasiones Orgasmo Meseta Excitación Masters WH, Johnson V. (1966) Human Sexual Response. Boston: Little, Brown & Co Ciclo de respuesta sexual femenina: Modelo no lineal • En 2001, Basson construyó un modelo no lineal de la respuesta sexual femenina. • El modelo alternativo de Basson incorpora una motivación basada en la intimidad, los estímulos sexuales, los factores confluyentes biológicos y psicológicos y la satisfacción. Intimidad Buscar y ser emocional receptivo Satisfacción emocional y física Impulso Estímul sexual os espontáneo sexuale s Excitación y deseo sexual Deseo Biológic sexual o PiPsico lóilógico Basson R.
    [Show full text]
  • WO 2017/151816 Al 8 September 2017 (08.09.2017) P O P C T
    (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2017/151816 Al 8 September 2017 (08.09.2017) P O P C T (51) International Patent Classification: Gilead Apollo, LLC, 333 Lakeside Drive, Foster City, C07D 495/04 (2006.01) A61P 3/00 (2006.01) California 94404 (US). YANG, Xiaowei; c/o Gilead A61K 31/519 (2006.01) A61P 3/06 (2006.01) Apollo, LLC, 333 Lakeside Drive, Foster City, California 94404 (US). (21) International Application Number: PCT/US20 17/020271 (74) Agents: TANNER, Lorna L. et al; Sheppard Mullin Richter & Hampton LLP, 379 Lytton Avenue, Palo Alto, (22) Date: International Filing California 94301-1479 (US). 1 March 2017 (01 .03.2017) (81) Designated States (unless otherwise indicated, for every (25) Filing Language: English kind of national protection available): AE, AG, AL, AM, (26) Publication Language: English AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, (30) Priority Data: DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, 62/302,755 2 March 2016 (02.03.2016) US HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KH, KN, 62/303,237 3 March 2016 (03.03.2016) US KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, (71) Applicant: GILEAD APOLLO, LLC [US/US]; 333 MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, Lakeside Drive, Foster City, California 94404 (US).
    [Show full text]
  • Bremelanotide (Vyleesi) Reference Number: ERX.SPA.347 Effective Date: 12.01.19 Last Review Date: 11.20 Line of Business: Commercial, Medicaid Revision Log
    Clinical Policy: Bremelanotide (Vyleesi) Reference Number: ERX.SPA.347 Effective Date: 12.01.19 Last Review Date: 11.20 Line of Business: Commercial, Medicaid Revision Log See Important Reminder at the end of this policy for important regulatory and legal information. Description Bremelanotide (Vyleesi™) is a melanocortin receptor agonist. FDA Approved Indication(s) Vyleesi is indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) as characterized by low sexual desire that causes marked distress or interpersonal difficulty and NOT due to: • A co-existing medical or psychiatric condition, • Problems with the relationship, or • The effects of a medication or drug substance. Limitation(s) of use: • Not indicated for treatment of HSDD in postmenopausal women or in men. • Not indicated to enhance sexual performance. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria. Health plan approved formularies should be reviewed for all coverage determinations. Requirements to use preferred alternative agents apply only when such requirements align with the health plan approved formulary. It is the policy of health plans affiliated with Envolve Pharmacy Solutions™ that Vyleesi is medically necessary when the following criteria are met: I. Initial Approval Criteria A. Hypoactive Sexual Desire Disorder (must meet all): 1. Diagnosis of HSDD in premenopausal women; 2. Age ≥ 18 years; 3. Failure of a 3-month trial of bupropion at up to maximally studied effective doses (see Appendix B), unless contraindicated or clinically significant adverse effects are experienced; 4. Vyleesi is not prescribed concurrently with Addyi; 5.
    [Show full text]
  • The Neurochemistry of Sexual Desire and Sexual Pleasure
    10/9/2018 The neurochemistry of sexual desire and sexual pleasure James G. Pfaus, PhD, IF Center for Studies in Behavioral Neurobiology Department of Psychology, Concordia University Montréal, QC, Canada 2018 Meeting of the North American Menopause Society Presidential symposium “Sexual desire: Wired for wild” 3 October 2018 Acknowledgements –Jim Pfaus Grants: Canadian Institutes for Health Research (CIHR), Fonds de la recherche en santé du Québec (FRSQ), and the Natural Sciences and Engineering Research Council (NSERC). Contracts/Ad Boards/Honoraria: Acadia Pharmaceuticals, Emotional Brain LLC; Palatin Technologies/AMAG Pharmaceuticals. 1 10/9/2018 Masters and Johnson’s (1966) EPOR Model, after Moll (1908) Male Female Voluptuous acme Equable voluptuous sensations Albert Moll (1862‐1939) The Onset Tumescence drive Detumescence drive and as modified by Kaplan (1974) and Georgiadis et al. (2012) William Masters and Virginia E. Johnson (1915‐2001) (1925‐2013) Helen Singer Kaplan (1929‐1995) Janniko Georgiadis (1973‐ ) Female Sexual Response Cycle Phases RESTING EXCITEMENT ORGASMIC PLATEAU Salonia A, Giraldi A, Chivers ML, Georgiadis JR, Levin R, Maravilla KR, McCarthy MM.: Physiology of women's sexual function: basic knowledge and new findings. J Sex Med. 2010;7:2637‐60. 2 10/9/2018 Female Sexual Response Cycle Faces RESTING EXCITEMENT ORGASMIC PLATEAU Salonia A, Giraldi A, Chivers ML, Georgiadis JR, Levin R, Maravilla KR, McCarthy MM.: Physiology of women's sexual function: basic knowledge and new findings. J Sex Med. 2010;7:2637‐60. Definitions
    [Show full text]
  • Salvage of Sildenafil Failures with Bremelanotide: a Randomized
    Salvage of Sildenafil Failures With Bremelanotide: A Randomized, Double-Blind, Placebo Controlled Study Mohammad Reza Safarinejad* and Seyyed Yousof Hosseini From the Urology and Nephrology Research Center, Shaheed Modarress Hospital, Shaheed Beheshti University of Medical Sciences, Tehran, Iran Purpose: We evaluated the safety and efficacy of intranasal bremelanotide in men with erectile dysfunction who did not respond to sildenafil. Materials and Methods:A total of 342 married men (28 to 59 years old) with erectile dysfunction who did not respond to sildenafil were randomly assigned to receive 10 mg bremelanotide as an intranasal spray (group 1, 172) 45 minutes to 2 hours prior to sexual stimulation, or a similar regimen of placebo (group 2, 170). Patients were asked to use at least 16 doses/attempts at home. They underwent preliminary assessment, including medical and sexual history, and self-administered International Index of Erectile Function. The efficacytreatments o f 2 was assessed every 4 attempts during treatment and at the end of study, using responses to International Index of Erectile Function, and evaluation of mean intercourse satisfaction domain, mean weekly coitus episodes and adverse drug effects. Results: Positive clinical results were seen in 51 (33.5%) patients in the bremelanotide group compared with 13 (8.5%) patients in the placebo groupϭ 0.03). (p Patients in the bremelanotide group reported significantly greater intercourse satisfaction than those in placebo groupϭ 0.03). (p More drug related adverse effects occurred in the bremelanotide group (p ϭ 0.01). Conclusions: Bremelanotide can be an alternative treatment for erectile dysfunction with a potentially broad patient base.
    [Show full text]