Fezolinetant Safe, Effective for Moderate-to-Severe Menopause Hot Flashes

MONDAY, May 20, 2024 (HealthDay News) — Fezolinetant is safe and effective for moderate-to-severe vasomotor symptoms (VMS), according to a study presented at the annual European Congress of Endocrinology, hosted by the European Society of Endocrinology from May 11 to 14 in Stockholm.

Angelica Lindén Hirschberg, M.D., Ph.D., from the Karolinska Institutet in Stockholm, and colleagues assessed early response to fezolinetant in terms of frequency and severity of moderate-to-severe VMS. The analysis included 453 women unsuitable for hormone therapy participating in the 24-week placebo-controlled DAYLIGHT study.

The researchers found that compared with those taking placebo, participants treated with fezolinetant (45 mg) had a greater reduction in the daily mean change in frequency of moderate-to-severe VMS from baseline through the first week of treatment (day 7 least squares mean difference, –2.20). There was a decrease observed in VMS frequency from days 1 to 6, with the strongest decrease seen during the first three days. Additionally, fezolinetant was associated with greater reduction in the daily mean change in VMS severity from days 2 to 7 compared with placebo (day 7 least squares mean difference, –0.17). Through week 24, improvements in VMS frequency and severity were sustained. There were no safety signals of concern reported through week 24.

“An effect on VMS frequency was seen as early as day 1 and maintained through the 24-week placebo-controlled period, demonstrating a rapid onset of action and sustained efficacy with fezolinetant treatment,” the authors write.

The study was funded by Astellas Pharma, the manufacturer of fezolinetant.

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