Fezolinetant Real-World Evidence Shows Broader Menopause Benefits
New data from the OPTION-VMS study shows fezolinetant (Veozah) improves hot flash bother, work productivity, and mood in menopausal women within 12 weeks, confirming trial results in everyday practice.
New real-world evidence shows fezolinetant improves hot flash bother, work productivity, and mood in menopausal women. The OPTION-VMS study found the nonhormonal treatment, also known as Veozah, delivered these broader functional benefits within 12 weeks in everyday patients seeking care for vasomotor symptoms.
Women reported improvement in hot flash bother at 4, 8, and 12 weeks. They also noted a substantial boost in workplace productivity and improved activity levels outside of work within the same period. Symptoms of depression and anxiety improved with fezolinetant after 12 weeks. The primary time point for assessment in the study was 12 weeks.
How the study measured outcomes beyond symptoms
Researchers used validated tools to assess bother, mood, and sleep objectively. They examined bother from vasomotor symptoms, meaning hot flashes and night sweats, using the MENQOL questionnaire. A widely used measure of workplace productivity was employed.
The study used the PHQ-9 to measure depression and the GAD-7 to measure anxiety. To add a dimension beyond patient reports, wrist-worn actigraphy captured sleep problems women might underreport. OPTION-VMS included assessment of VMS bother, mood, and sleep.
Why real-world evidence matters for menopause care
OPTION-VMS tests whether trial results apply to the broader population of women seeking care in clinical practice. The SKYLIGHT trials had already demonstrated the efficacy of fezolinetant on vasomotor symptoms and sleep. Randomized, placebo-controlled trials are the gold standard for understanding medication effects, with the placebo arm showing improvement expected by chance.
However, clinical trials often select relatively healthy participants who may differ from typical clinic patients. Many groups of women do not participate in clinical trials for various reasons. This study was designed to test external generalizability, or whether trial findings hold for the types of women seen in everyday practice.
Expert perspective on the findings
Pauline M. Maki, PhD, reviewed the early OPTION-VMS findings presented at The Menopause Society 2025 meeting. Maki, a professor of psychiatry, psychology, and obstetrics and gynecology at the University of Illinois Chicago, directs the Center for Health Awareness and Research on Menopause.
She describes the results as very reassuring because they replicated what was seen in the trials. The study is part of the Contemporary OB/GYN Investigator Perspectives series. OPTION-VMS is described as the first real-world evidence to include fezolinetant among nonhormonal menopausal therapies.
Context on fezolinetant and its use
Fezolinetant is a nonhormonal treatment shown to reduce VMS frequency and severity. The SKYLIGHT trials showed these benefits. New outcome data on fezolinetant and other nonhormonal interventions for depression and anxiety were presented at the Endocrine Society meeting in 2026.
In the OPTION-VMS study, participants presented to clinics seeking care for VMS. Most did not have substantial depression or anxiety at baseline, with levels at the first study visit being minimal. Women reported a substantial boost in workplace productivity within 12 weeks.
