Astellas announces initial findings from OPTION-VMS Phase IV trial

Study Overview: Astellas Pharma released preliminary data from the OPTION-VMS Phase IV study, highlighting the real-world effectiveness of fezolinetant in treating menopausal vasomotor symptoms (VMS) such as hot flashes and night sweats.

Key Findings: The data showed significant improvements in VMS bother, sleep quality, and overall activity impairment among women aged 40-75 who were prescribed fezolinetant, with positive outcomes measured at multiple time points (weeks 4, 8, and 12).

Safety Profile: The incidence of treatment-emergent adverse events related to fezolinetant was low and consistent with previous clinical trials, with no new safety concerns identified.

Presentation of Results: These preliminary findings will be presented at The Menopause Society 2025 Annual Meeting, with full results expected after the final analysis.