How long can patients stay on fezolinetant?

Published

In total, women have taken fezolinetant for up to 52 weeks in the Phase 3 clinical studies

  • The safety and efficacy of fezolinetant was evaluated in the Phase 3 SKYLIGHT 1 and 2 studies during placebo-controlled 12-week periods, followed by non-controlled, 40-week treatment extension periods1,2 The long-term safety and tolerability of fezolinetant was further evaluated in the Phase 3 placebo-controlled SKYLIGHT 4 study over 52 weeks.3
  • Fezolinetant decreased the frequency and severity of moderate to severe vasomotor symptoms in SKYLIGHT 1 and 2, observed from the first week and maintained through to the last week of treatment with no change in dose.1,2 Vasomotor symptoms began to return within one week of discontinuation.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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