There are no suggestions from nonclinical or clinical data that rebound could be expected with fezolinetant treatment
Figure 1. Weekly mean frequency of moderate and severe VMS per 24 hours over the 52-week treatment period and follow-up period in SKYLIGHT 1 and 23,4,6
Adapted from: Johnson KA J Clin Endocr Metab. 2023 and Lederman S Lancet. 2023.
Figure 2. Weekly mean severity of moderate and severe VMS per 24 hours over the 52week treatment period and follow-up period in SKYLIGHT 1 and 23,4,6
Adapted from: Johnson KA J Clin Endocr Metab. 2023 and Lederman S Lancet. 2023.
Fraser GL, Lederman S, Waldbaum A, et al. A phase 2b, randomized, placebo-controlled, double-blind, dose-ranging study of the neurokinin 3 receptor antagonist fezolinetant for vasomotor symptoms associated with menopause. Menopause. 2020;27(4):382-392. Available at: https://doi.org/10.1097/GME.0000000000001510.
Depypere H, Timmerman D, Donders G, et al. Treatment of Menopausal Vasomotor Symptoms With Fezolinetant, a Neurokinin 3 Receptor Antagonist: A Phase 2a Trial. J Clin Endocr Metab. 2019;104(12):5893-5905. Available at: https://doi.org/10.1210/jc.2019-00677.
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. J Clin Endocr Metab. 2023;108(8):1981-1997. Available at: https://doi.org/10.1210/clinem/dgad058.
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. Lancet. 2023;401(10382):1091-1102. Available at: https://doi.org/10.1016/s0140-6736(23)00085-5.
Neal-Perry G, Cano A, Lederman S, et al. Safety of Fezolinetant for Vasomotor Symptoms Associated With Menopause: A Randomized Controlled Trial. Obstet Gynecol. 2023;141(4):737-747. Available at: https://doi.org/10.1097/aog.0000000000005114.
Data on file.
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