Fezolinetant for Vasomotor Symptoms in Women for Whom Hormone Therapy Isn't an Option

Fezolinetant, a neurokinin-3 receptor antagonist, was U.S. FDA approved in 2023 for managing vasomotor symptoms of menopause (NEJM JW Gen Med Jul 1 2023 and Lancet 2023; 401:1091; J Clin Endocrinol Metab 2023; 108:1981; Obstet Gynecol 2023; 141:737). In this industry-sponsored trial, researchers randomized 450 women deemed to be unsuitable for hormone therapy (mean age, 54) to receive daily fezolinetant (45 mg) or placebo. Half of the participants had contraindications or comorbidities that raise caution for prescribing hormone therapy, generally reflecting FDA prescribing information; the remainder were either intolerant of hormone therapy (15%) or averse to its use (37%).

At baseline, patients had an average of 11 episodes daily of moderat…