Do patients need to taper off fezolinetant?

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In fezolinetant clinical trials, the last dose was administered without tapering

  • The safety and efficacy of fezolinetant was evaluated over 52 weeks in the Phase 3 trials SKYLIGHT 1, 2 (efficacy and safety) and 4 (safety).1–3 Dose increases and decreases were not allowed and the last dose of fezolinetant was administered without tapering.4 There was no evidence of a rebound effect on VMS in the three-week follow-up periods.4

  1. 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.

  2. 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.

  3. 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.

  4. Data on file.

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