Topline Real-World Data Show Fezolinetant Improves VMS, Sleep, and Work Productivity in Women With Confirmed Menopausal VMS

Preliminary real-world findings from the ongoing OPTION-VMS phase IV observational study show that fezolinetant (Veozah; Astellas Pharma), a nonhormonal neurokinin 3 (NK3) receptor antagonist, produced statistically significant improvements in bother from vasomotor symptom (VMS), sleep quality, and work productivity among women with moderate to severe menopausal symptoms.1

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The data, representing the first post-approval insights into fezolinetant use and were presented as late-breaking posters at The Menopause Society 2025 Annual Meeting in Orlando, Florida.

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). Women treated with fezolinetant met the study’s primary endpoint at week 12 and showed statistically significant improvements at earlier time points (weeks 4 and 8).1

Fezolinetant treatment led to1:

• 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 fezolinetant developer Astellas Pharma. The profile was consistent with prior clinical trials and postmarketing data, with no new safety signals identified.1

Significant improvements in patient-reported sleep quality and quality-of-life scores were also seen in women prescribed SSRIs/SNRIs or other non-HT agents such as gabapentin or oxybutynin. However, no statistically significant improvements in objective sleep measures (WASO, sleep efficiency, or sleep latency) were observed in the SSRI/SNRI group, while WASO improved significantly at all time points in the other non-HT group.1

On-the-Job Improvements

A separate preliminary analysis from the same study demonstrated that fezolinetant use was associated with statistically significant improvements in the Work Productivity and Activity Impairment questionnaire specific to VMS (WPAI-VMS). Improvements were seen across domains including activity impairment, overall work productivity loss, and presenteeism. Statistically significant gains were also reported in the SSRI/SNRI and other non-HT treatment groups.1

“With an estimated 1.2 billion women expected to be peri- or postmenopausal by 2030, and millions experiencing symptoms that can affect their wellbeing and professional lives, addressing the burden of menopause is more important than ever,” Genevieve Neal-Perry, MD, PhD, department chair, UNC School of Medicine Department of Obstetrics and Gynecology, said in a statement.2

Menopausal symptoms can significantly affect women’s quality of life and economic stability. About one-third of working women report difficulties coping at work due to menopause-related symptoms, and severe symptoms can prompt women to consider career changes, reduced work hours, or leaving the workforce altogether.3

“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,” Shayna Mancuso, DO, head, US medical affairs, women's health-fezolinetant, at Astellas, said.2

The ongoing OPTION-VMS study (NCT06049797) has enrolled 998 women at 50 sites across the US. 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.2

Fezolinetant is indicated for the treatment of moderate to severe vasomotor symptoms due to menopause and works by blocking neurokinin B binding on KNDy neurons in the hypothalamus to reduce hot flash frequency and intensity, according to Astellas.2

References

1. Neal-Perry G, Lederman S, Mancuso S, et al. Option-VMS: preliminary analysis of a Phase IV observational, real-world study of non-hormonal pharmacotherapies for bothersome menopause-associated vasomotor symptoms. Abstract presented at: The Menopause Society’s 2025 Annual Meeting; October 21-25, 2025; Orlando, FL. Accessed October 21, 2025.

2. Astellas presents preliminary real-world Veozah (fezolinetant) data from OPTION-VMS phase IV observational study. News release. Astellas Pharma. October 22, 2025. Accessed October 22, 2025. https://prnmedia.prnewswire.com/news-releases/astellas-presents-preliminary-real-world-veozah-fezolinetant-data-from-option-vms-phase-iv-observational-study-302591426.html

3. Whiteley J, DiBonaventura M dC, Wagner, J-S, Alvir J, Shah S. The impact of menopausal symptoms on quality of life, productivity, and economic outcomes. J Women's Health. 2013;22(11):983-990. doi:10.1089/jwh.2012.3719