Data from Phase 3 clinical trials, SKYLIGHT 1 and 2 and DAYLIGHT, demonstrated improvements in several patient-reported outcome measures of sleep disturbance with fezolinetant treatment
SKYLIGHT 1 and 2 individual trial results
Figure 1. Change in PROMIS SD SF 8b total score from Baseline to Weeks 4 and 12 in SKYLIGHT 1 and SKYLIGHT 28,9
*P<0.01 vs placebo. †P<0.001 vs placebo.
Mean (SD) Baseline values in SKYLIGHT 1: fezolinetant 45 mg, 27.1 (7.0); placebo, 26.4 (6.6).
Mean (SD) Baseline values in SKYLIGHT 2: fezolinetant 45 mg, 26.2 (6.6); placebo 27.4 (7.0).
Adapted from: Lederman S, Lancet 2023 and Johnson KA, J Clin Endocrinol Metab. 2023
SKYLIGHT 1 and 2 trial pooled analysis results
Figure 2. Change in PROMIS SD SF 8b total score from Baseline to Weeks 4 and 121
Baseline data (mean [SD]): placebo (26.9 [6.8]), fezolinetant 45 mg (26.7 [6.8]). A negative change indicated a reduction from Baseline (i.e., a favorable outcome).
All randomized participants assessed according to randomization at first dose (fezolinetant 45 mg: n = 341, placebo: n = 342).
Adapted from: Shapiro M, Maturitas 2024.
Figure 3. Change in PROMIS SRI SF 8a total score from Baseline to Weeks 4 and 121
Baseline data (mean [SD]): placebo (21.6 [7.4]), fezolinetant 45 mg (21.7 [7.2]). A negative change indicated a reduction from Baseline (i.e., a favorable outcome).
All randomized participants assessed according to randomization at first dose (fezolinetant 45 mg: n = 341, placebo: n = 342).
Adapted from: Shapiro M, Maturitas 2024.
Figure 4. Distribution of the PGI-C SD at Weeks 4 and 121
All randomized participants assessed according to randomization at first dose (fezolinetant 45 mg: n = 341, placebo: n = 342).
Adapted from: Shapiro M, Maturitas 2024.
Figure 5. Distribution of the PGI-S SD at Baseline, Week 4, and Week 121
All randomized participants assessed according to randomization at first dose (fezolinetant 45 mg: n = 341, placebo: n = 342).
Adapted from: Shapiro M, Maturitas 2024.
DAYLIGHT trial results
Figure 6. Change in PROMIS SD SF 8b total score from baseline to Week 242,10
Baseline data (mean [SD]): placebo (27.6 [6.3]), fezolinetant 45 mg (28.3 [6.1]).
All randomized participants assessed according to randomization at first dose (placebo: n = 226, fezolinetant 45 mg: n = 226).
A negative change indicated a reduction from baseline (i.e., a favorable outcome).
Adapted from: Schaudig K, BMJ 2024.
Figure 7. Distribution of PGI-C SD at Week 242
All randomized participants assessed according to randomization at first dose (fezolinetant 45 mg: n = 226, placebo: n = 226).
Adapted from: Schaudig K, BMJ 2024.
Figure 8. Distribution of PGI-S SD at Baseline and Week 243
All randomized participants assessed according to randomization at first dose (fezolinetant 45 mg: n = 226, placebo: n = 226).
Adapted from: Shapiro M, Maturitas 2024.
Shapiro M, Cano A, Nappi RE, et al. Effect of fezolinetant on sleep disturbance and impairment during treatment of vasomotor symptoms due to menopause. Maturitas. 2024; Available at: https://doi.org/10.1016/j.maturitas.2024.107999.
Schaudig K, Wang X, Bouchard C, et al. Efficacy and safety of fezolinetant for moderate-severe vasomotor symptoms associated with menopause in individuals unsuitable for hormone therapy: phase 3b randomized controlled trial. BMJ. 2024;(387):e079525. Available at: https://doi.org/10.1136/bmj-2024-079525.
Shapiro M, Wu X, Wang X, et al. Effect of fezolinetant on patient-reported quality-of-life outcomes: Data from a phase 3b study (DAYLIGHT) of the treatment of moderate to severe vasomotor symptoms associated with menopause in women considered unsuitable for hormone therapy. Maturitas. 2024; Available at: https://doi.org/10.1016/j.maturitas.2024.108159.
Thurston R, Chang Y, Buysse D, et al. Hot flashes and Awakenings Among Midlife Women. Sleep. 2019;(0161-8105) Available at: https://doi.org/10.1093/sleep/zsz131.
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. Available at: https://doi.org/10.1186/s41687-021-00289-y.
DePree B, Shiozawa A, King D, et al. Association of menopausal vasomotor symptom severity with sleep and work impairments: A US survey. Menopause. 2023;30(9):887-897. Available at: https://doi.org/10.1097/gme.0000000000002237.
Maki PM, Panay N, Simon JA. Sleep disturbance associated with the menopause. Menopause. 2024;31(8):724-733. Available at: https://doi.org/10.1097/gme.0000000000002386.
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.
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.
Data on file.
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