VMS in Menopause

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Download a PDF of the deck, "New and Emerging Approaches for Treating VMS Associated with Menopause" (PDF will download to your computer or open in new window, depending on your browser settings)

Additional Trial Results

Fezolinetant:

Skylight 4 (Phase 3 Safety) - Neal-Perry G, et al. Obstet Gynecol. 2023;141(4):737-747.  https://journals.lww.com/greenjournal/fulltext/2023/04000/safety_of_fezolinetant_for_vasomotor_symptoms.13.aspx

Daylight (Phase 3b) - Schaudig K, et al. BMJ, 2024;387:e079525. https://www.bmj.com/content/387/bmj-2024-079525

Elinzanetant:

Oasis 3 (Phase 3) - Panay N, et al. In: Proceedings and abstracts of the 2024 Annual Meeting of the Menopause Society, September 11–14, 2024. Chicago: Menopause Society, 2024. https://menopause.org/wp-content/uploads/2024/09/2024-Oral-and-Poster-Presentation-Abstracts.pdf

Oasis 4 (Phase 3) - Pinkerton JV, et al. JAMA. 2024;332(16):1343-1354. https://jamanetwork.com/journals/jama/fullarticle/2822766

Additional References

1. Avis NE, Crawford SL, Green R. Vasomotor Symptoms Across the Menopause Transition: Differences Among Women. Obstet Gynecol Clin North Am. 2018;45(4):629-640. doi:10.1016/j.ogc.2018.07.005

   https://pubmed.ncbi.nlm.nih.gov/30401547/

2. Freeman EW, Sammel MD, Sanders RJ. Risk of long-term hot flashes after natural menopause: evidence from the Penn Ovarian Aging Study cohort. Menopause. 2014;21(9):924-932. doi:10.1097/GME.0000000000000196

   https://pubmed.ncbi.nlm.nih.gov/24473530/

3. Hunter MS, Gentry-Maharaj A, Ryan A, et al. Prevalence, frequency and problem rating of hot flushes persist in older postmenopausal women: impact of age, body mass index, hysterectomy, hormone therapy use, lifestyle and mood in a cross-sectional cohort study of 10,418 British women aged 54-65. BJOG. 2012;119(1):40-50. doi:10.1111/j.1471-0528.2011.03166.x

   https://pubmed.ncbi.nlm.nih.gov/22008610/

4. Crandall CJ, Tseng CH, Crawford SL, et al. Association of menopausal vasomotor symptoms with increased bone turnover during the menopausal transition. J Bone Miner Res. 2011;26(4):840-849. doi:10.1002/jbmr.259

   https://pubmed.ncbi.nlm.nih.gov/20878774/

5. Thurston RC, Sowers MR, Sternfeld B, et al. Gains in body fat and vasomotor symptom reporting over the menopausal transition: the study of women’s health across the nation. Am J Epidemiol. 2009;170(6):766-774. doi:10.1093/aje/kwp203

   https://pubmed.ncbi.nlm.nih.gov/19675142/

6. Avis NE, Crawford SL, Greendale G, et al. Duration of menopausal vasomotor symptoms over the menopause transition. JAMA Intern Med. 2015;175(4):531-539. doi:10.1001/jamainternmed.2014.8063

   https://pubmed.ncbi.nlm.nih.gov/25686030/

7. Freeman EW, Sammel MD, Lin H, Liu Z, Gracia CR. Duration of menopausal hot flushes and associated risk factors. Obstet Gynecol. 2011;117(5):1095-1104. doi:10.1097/AOG.0b013e318214f0de

   https://pubmed.ncbi.nlm.nih.gov/21508748/

8. Williams RE, Kalilani L, DiBenedetti DB, Zhou X, Fehnel SE, Clark RV. Healthcare seeking and treatment for menopausal symptoms in the United States. Maturitas. 2007;58(4):348-358. doi:10.1016/j.maturitas.2007.09.006

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9. Freedman RR, Krell W. Reduced thermoregulatory null zone in postmenopausal women with hot flashes. Am J Obstet Gynecol. 1999;181(1):66-70. doi:10.1016/s0002-9378(99)70437-0

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10. Kronenberg F. Hot flashes: epidemiology and physiology. Ann N Y Acad Sci. 1990;592:52-86; discussion 123-133. doi:10.1111/j.1749-6632.1990.tb30316.x

    https://pubmed.ncbi.nlm.nih.gov/2197954/

11. Menown SJ, Tello JA. Neurokinin 3 Receptor Antagonists Compared With Serotonin Norepinephrine Reuptake Inhibitors for Non-Hormonal Treatment of Menopausal Hot Flushes: A Systematic Qualitative Review. Adv Ther. 2021;38(10):5025-5045. doi:10.1007/s12325-021-01900-w

    https://pubmed.ncbi.nlm.nih.gov/34514552/

12. The NAMS 2017 Hormone Therapy Position Statement Advisory Panel. The 2017 hormone therapy position statement of The North American Menopause Society. Menopause. 2017;24(7):728-753. doi:10.1097/GME.0000000000000921

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13. Rossouw JE, Anderson GL, Prentice RL, et al. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results From the Women’s Health Initiative randomized controlled trial. JAMA. 2002;288(3):321-333. doi:10.1001/jama.288.3.321

    https://pubmed.ncbi.nlm.nih.gov/12117397/

14. Nonhormonal management of menopause-associated vasomotor symptoms: 2015 position statement of The North American Menopause Society. Menopause. 2015;22(11):1155-1172; quiz 1173-1174. doi:10.1097/GME.0000000000000546

    https://pubmed.ncbi.nlm.nih.gov/26382310/

15. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opinion on Investigational Drugs. 2021;30(7):681-694. doi:10.1080/13543784.2021.1893305

    https://pubmed.ncbi.nlm.nih.gov/33724119/

16. The American College of Obstetricians and Gynecologists. Management of Menopausal Symptoms. January 2014. Accessed October 21, 2024. https://www.acog.org/en/clinical/clinical-guidance/practice-bulletin/articles/2014/01/management-of-menopausal-symptoms

    https://pubmed.ncbi.nlm.nih.gov/24463691/

17. Hill DA, Crider M, Hill SR. Hormone Therapy and Other Treatments for Symptoms of Menopause. Am Fam Physician. 2016;94(11):884-889.

    https://pubmed.ncbi.nlm.nih.gov/27929271/

18. Kling JM, MacLaughlin KL, Schnatz PF, et al. Menopause Management Knowledge in Postgraduate Family Medicine, Internal Medicine, and Obstetrics and Gynecology Residents: A Cross-Sectional Survey. Mayo Clinic Proceedings. 2019;94(2):242-253. doi:10.1016/j.mayocp.2018.08.033

    https://pubmed.ncbi.nlm.nih.gov/30711122/

19. Welsh ET, Schaffer R. Poor hot flash documentation in primary care setting leaves many midlife women untreated. October 7, 2024. Accessed October 16, 2024. https://www.healio.com/news/womens-health-ob-gyn/20241007/poor-hot-flash-documentation-in-primary-care-setting-leaves-many-midlife-women-untreated

    https://www.healio.com/news/womens-health-ob-gyn/20241007/poor-hot-flash-documentation-in-primary-care-setting-leaves-many-midlife-women-untreated

20. Nappi RE, Kroll R, Siddiqui E, et al. Global cross-sectional survey of women with vasomotor symptoms associated with menopause: prevalence and quality of life burden. Menopause. 2021;28(8):875-882. doi:10.1097/GME.0000000000001793

    https://pubmed.ncbi.nlm.nih.gov/34033602/

21. TherapeuticsMD Inc. TherapeuticsMD Announces FDA Approval of TX-001HR: BIJUVA^TM (Estradiol and Progesterone) Capsules for the Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause. October 29, 2018. Accessed October 21, 2024. https://ir.therapeuticsmd.com/news-releases/news-release-details/therapeuticsmd-announces-fda-approval-tx-001hr-bijuvatm

    https://ir.therapeuticsmd.com/news-releases/news-release-details/therapeuticsmd-announces-fda-approval-tx-001hr-bijuvatm

22. Welsh E. Menopausal hormone therapy use fell 82% since 1999, as ‘negative perceptions’ persist. September 27, 2024. Accessed October 16, 2024. https://www.healio.com/news/womens-health-ob-gyn/20240927/menopausal-hormone-therapy-use-fell-82-since-1999-as-negative-perceptions-persist

    https://www.healio.com/news/womens-health-ob-gyn/20240927/menopausal-hormone-therapy-use-fell-82-since-1999-as-negative-perceptions-persist

23. Al-Dossari R, Gossard G, and Watts, B. The Impact of Team Based Learning on Confidence of Physicians’ Care for Menopausal Women. NAMS Abstract. 2021;P-1.

    https://www.menopause.org/docs/default-source/agm/nams-2021-oral-and-poster-presentation-abstracts.pdf.

24. Modi M, Dhillo WS. Neurokinin 3 Receptor Antagonism: A Novel Treatment for Menopausal Hot Flushes. Neuroendocrinology. 2019;109(3):242-248. doi:10.1159/000495889

    https://pubmed.ncbi.nlm.nih.gov/30504731/

25. US Food & Drug Administration. FDA Approves Novel Drug to Treat Moderate to Severe Hot Flashes Caused by Menopause. FDA. May 12, 2023. Accessed October 16, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-novel-drug-treat-moderate-severe-hot-flashes-caused-menopause

    https://www.fda.gov/news-events/press-announcements/fda-approves-novel-drug-treat-moderate-severe-hot-flashes-caused-menopause

26. Lederman S, Ottery FD, Cano A, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. The Lancet. 2023;401(10382):1091-1102. doi:10.1016/S0140-6736(23)00085-5

    https://pubmed.ncbi.nlm.nih.gov/36924778/

27. Neal-Perry G, Cano A, Lederman S, et al. Safety of Fezolinetant for Vasomotor Symptoms Associated With Menopause: A Randomized Controlled Trial. Obstetrics & Gynecology. Published online March 9, 2023. doi:10.1097/AOG.0000000000005114

    https://pubmed.ncbi.nlm.nih.gov/36897180/

28. Johnson KA, Martin N, Nappi RE, et al. Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. The Journal of Clinical Endocrinology & Metabolism. 2023;108(8):1981-1997. doi:10.1210/clinem/dgad058

    https://pubmed.ncbi.nlm.nih.gov/36734148/

29. Pawsey S, Mills EG, Ballantyne E, et al. Elinzanetant (NT-814), a Neurokinin 1,3 Receptor Antagonist, Reduces Estradiol and Progesterone in Healthy Women. J Clin Endocrinol Metab. 2021;106(8):e3221-e3234. doi:10.1210/clinem/dgab108

    https://pubmed.ncbi.nlm.nih.gov/33624806/

30. Communications BA. Bayer starts Phase III clinical development program OASIS with Elinzanetant. October 7, 2021. Accessed March 18, 2022. https://www.bayer.com/en/ca/bayer-starts-phase-iii-clinical-development-program-oasis-with-elinzanetant

    https://www.bayer.com/en/ca/bayer-starts-phase-iii-clinical-development-program-oasis-with-elinzanetant

31. Pinkerton JV, Simon JA, Joffe H, et al. Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause: OASIS 1 and 2 Randomized Clinical Trials. JAMA. Published online August 22, 2024. doi:10.1001/jama.2024.14618

    https://pubmed.ncbi.nlm.nih.gov/39172446/

32. Bayer. Data from Phase III study OASIS 3 support efficacy and long-term safety of investigational compound elinzanetant in the treatment of moderate to severe vasomotor symptoms. September 10, 2024. Accessed October 16, 2024. https://www.bayer.com/en/us/news-stories/phase-iii-study-oasis-3

    https://www.bayer.com/en/us/news-stories/phase-iii-study-oasis-3

33. Bayer. U.S. Food and Drug Administration (FDA) accepts New Drug Application for elinzanetant. U.S. Food and Drug Administration (FDA) accepts New Drug Application for elinzanetant. October 9, 2024. Accessed October 16, 2024. https://www.bayer.com/media/en-us/us-food-and-drug-administration-fda-accepts-new-drug-application-for-elinzanetant/

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34. Rahman SA, Nathan MD, Wiley A, et al. A double-blind, randomized, placebo-controlled trial of suvorexant for the treatment of vasomotor symptom-associated insomnia disorder in midlife women. Sleep. 2022;45(3):zsac007. doi:10.1093/sleep/zsac007

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35. Rahimzadeh P, Imani F, Nafissi N, Ebrahimi B, Faiz SHR. Comparison of the effects of stellate ganglion block and paroxetine on hot flashes and sleep disturbance in breast cancer survivors. CMAR. 2018;Volume 10:4831-4837. doi:10.2147/CMAR.S173511

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36. Conklin M, Santoro N. Neurokinin receptor antagonists as potential non-hormonal treatments for vasomotor symptoms of menopause. Clin Med Insights Reprod Health. 2023;17:26334941231177611. doi:10.1177/26334941231177611

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38. English M, Stoykova B, Slota C, et al. Qualitative study: burden of menopause-associated vasomotor symptoms (VMS) and validation of PROMIS Sleep Disturbance and Sleep-Related Impairment measures for assessment of VMS impact on sleep. J Patient Rep Outcomes. 2021;5(1):37. doi:10.1186/s41687-021-00289-y

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