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New Insights into VEOZAH™ (fezolinetant) and Its Impact on Menopause Symptoms and Sleep

In a groundbreaking presentation at the 2026 International Menopause Society (IMS) World Congress on Menopause, Astellas Pharma unveiled new preliminary data from the Phase 4 OPTION-VMS study. This study focuses on VEOZAH (fezolinetant 45mg), a non-hormonal treatment approved for addressing moderate to severe vasomotor symptoms (VMS), commonly known as hot flashes and night sweats, associated with menopause. The findings highlighted significant improvements in sleep outcomes for women experiencing these symptoms.

Study Findings

The analysis revealed statistically significant enhancements in both troublesome VMS and sleep quality at the 12-week mark, aligning with the study's primary endpoint. Notably, participants reported improvements as early as four weeks into the treatment. Specifically, the study recorded a mean reduction of 2.6 nighttime awakenings by week 12. Sleep disturbances, which plague around 40-60% of menopausal women, were effectively mitigated by the administration of VEOZAH. Women suffering from severe hot flashes were found to experience approximately three times the frequency of nighttime awakenings compared to those without such symptoms.

OPTION-VMS explored the experiences of women prescribed non-hormonal therapies, including VEOZAH, SSRIs, and other alternatives, in real-world clinical settings. By integrating subjective self-reported data alongside objective measurements acquired through wearable devices, OPTION-VMS paints a more robust picture of how these therapies impact daily life, particularly regarding sleep quality.

The preliminary analysis highlighted significant improvements in:

• - Bothersome VMS, measured via MENQOL VMS domain scores at 12 weeks, with notable shifts occurring at weeks 4 and 8 (all p<0.001).
• - Patient-reported sleep disturbances, observed through PROMIS SD SF 8b assessments, which transitioned from mild disturbances at baseline to a state of no disturbances by the four-week mark, with gains maintained through week 12 (p<0.001).
• - Objective sleep quality metrics, such as wakefulness after sleep onset (WASO) and nighttime awakenings at the specified intervals (all p<0.05).

Interestingly, no new safety concerns emerged, as the mild hepatic lab findings were infrequent, with only two cases of non-serious liver test elevations, neither of which necessitated treatment discontinuation.

Expert Commentary

Professor Marla Shapiro, of the University of Toronto, emphasized the profound impact that hot flashes and night sweats can have on women's lives, extending to their sleep and overall well-being. The new evidence from this real-world study reinforces the clinical program's findings, showcasing how VEOZAH alleviates troublesome vasomotor symptoms and enhances sleep for women.

Additional data presented at the conference offers further insights from ongoing studies, including interim analyses from GRACE and ADELE, both exploring VEOZAH's effectiveness in different populations. Such studies fortify the real-world applicability of the findings and contribute significantly to understanding how treatments can be tailored to meet women's needs.

What is VEOZAH?

VEOZAH is classified as a selective neurokinin 3 (NK3) receptor antagonist, uniquely designed to interfere with neurokinin B binding. This mechanism targets the brain's temperature control systems, effectively reducing the frequency and intensity of menopause-related hot flashes and night sweats. Currently, VEOZAH is available in 50 countries, offering a vital option for women seeking relief without hormonal interventions.

In conclusion, the preliminary findings presented by Astellas Pharma not only underscore the efficacy of VEOZAH in managing symptoms associated with menopause but also highlight the critical connection between these symptoms and their profound effects on sleep quality. As discussions around menopause continue to evolve, data-driven insights like those from the OPTION-VMS study are invaluable in shaping informed conversations between women and their healthcare providers.