Fezolinetant Shows Real-World Benefits for Menopausal Symptoms: Daily Dose

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On October 22, 2025, we reported on topline real-world data presented at The Menopause Society 2025 Annual Meeting from the ongoing OPTION-VMS phase IV observational study.

The study

The OPTION-VMS analysis included more than 900 women aged 40–75 years with confirmed menopausal VMS who were prescribed a nonhormonal therapy (non-HT) for bothersome VMS: fezolinetant, SSRIs/SNRIs, gabapentin, oxybutynin). Its primary objective is to evaluate changes in VMS bother among women prescribed a nonhormonal therapy in real-world settings, with secondary outcomes assessing sleep, sexual health, mood, work productivity, and safety.

The findings

Results showed that fezolinetant treatment led to:

• Statistically significant reductions in VMS bother as measured by the Menopause-Specific Quality of Life (MENQOL) VMS domain at week 12 (primary endpoint) and at weeks 4 and 8 (secondary endpoints).

• Statistically significant improvements in total MENQOL T scores and across domain categories (sexual, psychosocial, and physical) at weeks 4, 8, and 12.

• Statistically significant reductions in patient-reported sleep disturbance, reflected in PROMIS SD SF 8b Total T scores, at all three time points.

• Objective sleep improvements by actigraphy, including reduced wakefulness after sleep onset (WASO) at weeks 4, 8, and 12, and improved sleep efficiency at weeks 4 and 12.

The incidence of fezolinetant-related treatment-emergent adverse events was low, according to researchers. The profile was consistent with prior clinical trials and postmarketing data, with no new safety signals identified.

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