Astellas Pharma has unveiled encouraging preliminary findings from its ongoing phase 4 OPTION-VMS observational study, showing that fezolinetant significantly improves symptoms of vasomotor symptoms (VMS) associated with menopause.
The study, involving over 900 women aged 40–75 with confirmed menopausal VMS, demonstrated statistically significant improvements in VMS bother, sleep quality and work productivity at weeks 4, 8 and 12. These findings will be presented at The Menopause Society 2025 Annual Meeting in Orlando, Florida.
Genevieve Neal-Perry, Department Chair at UNC School of Medicine, explained: “These preliminary findings strengthen the evidence that fezolinetant is an effective treatment for women with disruptive vasomotor symptoms associated with menopause. Beyond the notable reductions in bothersome VMS as early as week 4, women reported improvements in sleep, work productivity and daily functioning.”
The study also reported statistically significant improvements in both subjective and objective sleep outcomes, including sleep efficiency and wakefulness after sleep onset. Improvements were measured using PROMIS SD SF 8b and actigraphy endpoints.
Shayna Mancuso, Head of US Medical Affairs, Women’s Health–Fezolinetant at Astellas, said: “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. 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.”
The incidence of treatment-emergent adverse events was low and consistent with previous data, with no new safety signals observed. Full results from the study will be available following final analysis.
