The neurokinin 3 receptor antagonist fezolinetant reduces the frequency and severity of vasomotor symptoms in menopause, according to study results presented at the North American Menopause Society Annual Meeting, held September 25 to 28, 2019, in Chicago, Illinois.
The study researchers aimed to evaluate the effects of fezolinetant on vasomotor symptoms and patient-reported outcomes in menopausal women aged 40 to 65 years in a phase 2b randomized placebo-controlled double-blind dose-ranging study.
A total of 356 women (mean age, 54.6±4.7 years; 73% white) with moderate to severe vasomotor symptoms received fezolinetant (15, 30, 60, or 90 mg twice daily, or 30, 60, or 120 mg once daily) or placebo. Primary outcomes were changes in the frequency or severity of vasomotor symptoms at 4 and 12 weeks. Secondary outcomes included response to treatment (measured as ≥50% reduction in vasomotor symptoms), as well as changes in patient-reported outcomes, measured by the Hot Flash-Related Daily Interference Scale, Greene Climacteric Scale, and Menopause-Specific Quality of Life questionnaire scores.
Treatment with fezolinetant reduced the daily frequency of moderate to severe vasomotor symptoms at both 4 and 12 weeks (P <.05). The severity of symptoms was also reduced with all doses at 4 weeks (P <.05), as well as at 12 weeks with a dose of 60 or 90 mg twice daily or 60 mg once daily (P <.05).
Response rates were higher with fezolinetant treatment at 15, 30, 60, and 90 mg twice daily (83.7%, 81.4%, 88.1%, and 94.7%, respectively), as well as at 30, 60, and 120 mg once daily (82.1%, 88.1%, and 84.1%, respectively), compared with placebo control (58.5%; P <.05). At all doses, treatment with fezolinetant resulted in improved patient-reported outcomes; reductions in Hot Flash-Related Daily Interference Scale and Menopause-Specific Quality of Life scores over previously published minimally important difference values were seen at 4 and 12 weeks.
“Fezolinetant reduced frequency and severity of [vasomotor symptoms], which was accompanied by clinically meaningful improvements in [patient-reported outcomes],” the researchers concluded.
Disclosure: This study was funded by Astellas Pharma, Inc.
Santoro N, Waldbaum A, Lederman S, et al. Effect of the neurokinin 3 receptor antagonist fezolinetant on menopausal vasomotor symptoms and patient-reported outcomes: results of a randomized, placebo-controlled, double-blind, dose-ranging study. Presented at: North American Menopause Society 2019 Annual Meeting; September 25-28, 2019; Chicago, IL. Abstract S-11.