How long can patients stay on fezolinetant?

Published

The fezolinetant product information does not specify a treatment duration. Women took fezolinetant for up to 52 weeks in the Phase 3 clinical studies

  • Treatment decisions are left to the clinical discretion of the prescriber based on institutional protocol, practice guidelines, and patient-specific characteristics and response.
  • 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 (VMS) in SKYLIGHT 1 and 2, observed from the first week and maintained through the last week of treatment with no change in dose.1,2 VMS 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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