Fezolinetant significantly reduced the frequency and severity of moderate-to-severe vasomotor symptoms (VMS), or hot flashes, associated with menopause, according to a Phase 3 industry-sponsored study being presented Saturday at ENDO 2022, the Endocrine Society’s annual meeting in Atlanta, Ga.
The SKYLIGHT 2 trial was a 52-week study to investigate the safety and efficacy of fezolinetant (a neurokinin 3 receptor antagonist) on the frequency and severity of moderate-to-severe VMS and sleep disturbance. The mean change in patient-reported sleep disturbance, from baseline to week 12, was a key secondary endpoint in the study.
“VMS associated with menopause, which are characterized by hot flashes and/or night sweats, affect millions of women worldwide and can impact daily activities and quality of life,” said Genevieve Neal-Perry, M.D, Ph.D., Distinguished Professor and Chair of Obstetrics and Gynecology at the University of North Carolina School of Medicine in Chapel Hill, N.C.
The double-blind Phase 3 study randomized 501 post-menopausal women ages 40–65 with an average of seven or more moderate-to-severe hot flashes/day to placebo or one of two once-daily doses of fezolinetant—30mg or 45mg—for 12 weeks. In the extension period, those on placebo were re-randomized to fezolinetant 30mg or 45mg, and those originally on fezolinetant remained on their dose for the remaining 40 weeks. The extension period analysis comprised 484 women.
Neal-Perry and colleagues evaluated the efficacy of fezolinetant compared to placebo and found improvement in VMS frequency and severity through week 12. Both doses were associated with a statistically significant reduction in the frequency and severity of hot flashes, which was maintained through the 52-week study period. Data support the overall safety and tolerability previously observed for fezolinetant at the 30 and 45 mg doses.
Those who were re-randomized from placebo to fezolinetant experienced a reduction in frequency and severity of VMS consistent with the women initially randomized to fezolinetant. The treatment also reduced sleep disturbances as assessed by Patient-Reported Outcomes Measurement Information System Sleep Disturbance (PROMIS SD SF 8b).
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