Real-world data show fezolinetant improves vasomotor symptoms, sleep, and work productivity in postmenopausal women.
New preliminary results from the OPTION-VMS phase 4 observational study demonstrate that fezolinetant (VEOZAH; Astellas Pharma) significantly improves vasomotor symptoms (VMS), sleep quality, and daily functioning among postmenopausal women in a real-world setting. The findings, presented as late-breaker poster presentations at The Menopause Society’s 2025 Annual Meeting in Orlando, Florida, offer the first insights into real-world use of fezolinetant, a nonhormonal neurokinin 3 (NK3) receptor antagonist.1,2
The OPTION-VMS study (NCT06049797) is an ongoing, longitudinal, real-world, non-comparative phase 4 study of women aged 40 to 75 years with confirmed menopausal VMS who were prescribed a nonhormonal therapy for the management of hot flashes and night sweats. The primary objective was to evaluate changes in VMS bother over 12 weeks among women initiating non-hormonal treatment.
Of 998 enrolled women across 50 US sites, 761 initiated a nonhormonal therapy and 656 met full analysis criteria. Among these, 201 women were prescribed fezolinetant. Investigators assessed changes from baseline at weeks 4, 8, and 12 using validated patient-reported outcomes, including the Menopause-Specific Quality of Life (MENQOL) questionnaire and the PROMIS Sleep Disturbance Short Form 8b (PROMIS SD SF 8b). Objective sleep measures were also captured using actigraphy (ActiGraph LEAP).
Women treated with fezolinetant demonstrated statistically significant improvements in VMS bother related to menopause, as indicated by reductions in MENQOL VMS domain scores at week 12, the study’s primary endpoint, as well as at weeks 4 and 8. Fezolinetant use was also associated with significant improvements in total MENQOL scores and in the sexual, psychosocial, and physical domains, reflecting improvements in overall menopause-related quality of life.
Objective and subjective sleep measures improved with fezolinetant therapy. Actigraphy results showed statistically significant reductions in wakefulness after sleep onset and improved sleep efficiency at weeks 4, 8, and 12. PROMIS SD SF 8b scores, representing patient-reported sleep quality, also improved significantly across all time points.
“These preliminary findings strengthen the evidence that fezolinetant is an effective treatment for women with disruptive vasomotor symptoms associated with menopause,” said Genevieve Neal-Perry, MD, PhD, department chair, University of North Carolina School of Medicine Department of Obstetrics and Gynecology, and a lead investigator in the study. “Beyond the notable reductions in bothersome VMS as early as week 4, women reported improvements in sleep, work productivity, and daily functioning.”
The incidence of fezolinetant-related treatment-emergent adverse events was low and consistent with findings from prior clinical trials and postmarketing experience. No new safety signals were observed in the preliminary analysis.
Fezolinetant treatment also led to significant improvements in patient-reported activity impairment and work productivity, according to the Work Productivity and Activity Impairment Questionnaire specific to VMS (WPAI-VMS). Participants reported improvements in overall work productivity, activity impairment, and presenteeism.
“These new preliminary findings reinforce Astellas’ commitment to advancing our understanding of fezolinetant beyond the pivotal clinical trials, with the goal of driving meaningful change for those affected by VMS,” said Shayna Mancuso, DO, FACOG, head of US Medical Affairs, Women’s Health-Fezolinetant, Astellas. “Hot flashes and night sweats are among the most common and disruptive symptoms of menopause, and when left untreated, they can significantly impair sleep, concentration, and daily functioning.”
Vasomotor symptoms, commonly described as hot flashes and night sweats, affect a majority of women transitioning through menopause and can have profound effects on quality of life, including sleep disturbance and occupational functioning. Prior randomized controlled trials have shown that fezolinetant effectively reduces the frequency and severity of VMS, and these new real-world data reinforce those findings in broader patient populations.
The OPTION-VMS preliminary results provide real-world evidence supporting fezolinetant’s role as a safe and effective nonhormonal option for managing menopausal vasomotor symptoms. Improvements were observed not only in VMS bother but also in sleep, quality of life, and productivity. Final data from the full study are expected to provide additional insights into the long-term real-world effectiveness of fezolinetant.
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