Conversations with Women About Female Sexual Dysfunction (FSD)

Total Page:16

File Type:pdf, Size:1020Kb

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. a positive physical effect Increased sexual arousal, a delay in or absence of orgasm, medical condition “At first it was gradual, but then, all of a sudden, it You don’t like me. And he was putting a lot of pressure on himself .” • Tingling in the genital area and sometimes in other parts of satisfaction] we had before, that had kind of been lost .” sexual desire and sexual pain .1,2 The most common sexual • None used the phrase “sexual dysfunction” to describe was like, you know we went from having sex once Partner Emotionally Impacted the body, as well as a transient feeling of warmth or flushing, “Greatly [impacted sexual satisfaction]. Things were better. a week to not even having it once a month.…and, I actually wanted to have sex more often .” Increased concern expressed by women is diminished or their problem “He actually went through a phase for a couple of months where were the most frequently mentioned physical effects sexual 3,4 I thought maybe was him. Is he not wanting to? lack of desire for sexual activity, which may he seemed almost depressed .” “Of course [sexual satisfaction increased]! You didn’t get Improved Improvement satisfaction • Responses concerning the cause of their condition “I actually felt, kind of like, a tingling sensation, if you will, Increased be diagnosed as hypoactive sexual desire But it wasn’t him. It was me .” that from everything I’ve been saying? …Every single time. ability to in sexual varie d— having/taking care of children was mentioned Creates Stressful Barriers, Magnifying Other Problems in my clitoral region .” sexual “It’s just there would be times when it was…when it achieve function and Improved disorder (HSDD), if the lack of desire causes most frequently, followed by aging Every time it was like the first time .” arousal just happened, whether it was him or me. I guess “…that wall of frustration between my husband and I as far as lack “You don’t really perspire, it’s just a warm feeling all over.” orgasm responsiveness mood, sexual Improved distress. Bremelanotide (BMT), a novel cyclic of sexual interaction that we had. When you are stressed about the “Much more confidence that I was satisfying him more, self-image, partner 7-amino acid melanocortin-receptor agonist Women’s Thoughts on Why They Experienced FSD there was a time when I would initiate it...There was sexual part, everything else seems to get bothered more easily .” “I would get a tingling down in the genital area. (Interviewer: and I was satisfying myself .” and relationship with the potential to modulate neural pathways a time when it was both of us initiating it and then And was it a pleasant thing?). Yes, it was pleasant. That con!dence “After the birth of my third child, I noticed a very rapid him initiating it, and, then to a point where I am Creates Uncertainty, Distrust, and Concerns About Viability Improved Self-Confidence and Sexual Self-Image Improved involved in sexual response ,5,6 is being would last for a good hour or so .” decline in sexual drive…It was pretty severe, enough to like, No!” of Relationship lubrication developed to treat FSD. send me to a doctor to beg for help .” “You worry about, well, if you’re not getting it with me, are you Sexual Desire Increased A majority of women taking the 1.25- or 1.75-mg doses of BMT reported experiencing an improvement in self-confidence “I really honestly think it was, that it is, because I’m Multiple Aspects of Women’s Lives Were going somewhere else? You have all of those kinds of con - Approximately 6 of 10 women receiving 1.25 or 1.75 mg of cerns.”“I know in certain arguments that we might have he will or sexual self-image. getting older.” A ffected by FSD BMT reported experiencing an increase in sexual desire. Aims “At first I thought maybe hormones; I think it is hormonal .” say that he thinks my eyes are wandering.” “I feel more confident now. Before, you sort of feel inade - The objectives of these interviews were to “I could have been (in) early menopause .” Impacts on Her “[Before] I really didn’t want to. Please, not tonight. But you Sexual Satisfaction—What Women Want and take it, and you want t o… I started to look forward to it again .” quate. What’s wrong with me? …I don’t have that problem Conclusions understand the impact of FSD and to provide “…some of it I think is just my physica l… my weight gain. Absence of Physical and Mental Responses to What Was Missing anymore .” a contextualized understanding of the effects …I honestly put on 20 lbs in 4 years. I have more of a Her Partner “I feel it made me want to again. It did sort of restore things • These interviews provided a wealth of contextual Mutual Feeling of Sharing Intimacy, Giving back to our original state .” “I felt sexy. I had control of my body. I felt satisfied and felt of BMT and the meaningfulness of the benefits desk job now, so I’m not moving around. And, I think that Sexual Desire* “I didn’t have the feeling, and then, the sexy. Felt frisky.” understanding of women’s experiences with FSD and it provides, beyond the previously reported may have something to do with it, because just putting on lack of desire altogether. So my body just and Taking “I was initiating more about 50% of the time. Pre-trial it was weight, and being tire d…” “I definitely felt better about myself. I felt like my sexual life was the positive impact that successful treatment with quantitative clinical study results. doesn’t respond very well when I am in “It’s more of a feeling. I guess I want to say a mutual feeling 70% him initiating .” that situation.” finally in step with the rest of my life, or it was getting there .” “I have no desire at all. I could go for the next 6 months between the two of us as to be giving each other the Sexual Arousal Increased BMT had on their health and well-being without it and it would not faze me. And, that right there, Arousal † “When he would caress me or try to pleasure of having that intimacy, that physical closeness, “I think it just made me feel desirable, sexy, younger .… Methods to me, scares me. I don’t understand that. I have no stimulate me, it wouldn’t happen. Not just that arousal, everything .” BMT had a positive effect on sexual arousal, particularly at and, in my mind, ‘oh, if I feel this good, maybe I look as • The effects of FSD extend well beyond physical understanding of that concept to me because it’s never mentally, but physically as well.” the 1.25- and 1.75-mg doses, where approximately two-thirds good as at 21 .’” symptoms • In a blinded phase 2b trial, premenopausal happened before, not even for a little while.” It’s Not Just About Sex of women said they experienced an improvement. women with HSDD (with or without female Orgasm “Most of the time, I was faking [orgasms]… Improved Mood “I thought it was a mind thing.” because I wanted him to be happy.” “I mean, intimacy, the physical satisfactio n— all of it is • Most participants reported improvements in their sexual arousal disorder [FSAD]) self-injected “[Before the trial], it was hard to get aroused. And when Approximately half to two-thirds of women taking the 1.25- or Physical Changes That Made Having Sex Uncomfortable important. The intimacy is most important because, without I did, I would get so close to the orgasm and then it was sexual response, frequency, quality of sexual placebo or 1 of 3 doses of BMT (0.75, 1.25, 1.75-mg doses of BMT reported feeling happier, relieved, Physician Interactions for Women it, it’s just sex .” gone, and you would spend so much time trying.
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]
  • 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]
  • 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
    [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]