Therapeutic efficacy of Fezolinetant

1 Effects on Vasomotor Symptoms in Postmenopausal Women

The co-primary efficacy endpoints for both trials were the mean change from baseline in moderate to severe vasomotor  symptoms frequency and severity to Weeks 4 and 12. Data from each trial demonstrated statistically significant and  clinically meaningful (≥ 2 hot flashes over 24 hours) reduction from baseline in the frequency of moderate to severe  vasomotor symptoms for Fezolinetant 45 mg compared to placebo at Weeks 4 and 12. 

Data from each trial also  demonstrated a statistically significant reduction from baseline in the severity of moderate to severe vasomotor symptoms  (over 24 hours) at Weeks 4 and 12 for Fezolinetant 45 mg compared to placebo.

from FDA，2024.08