Core Insights - Astellas Pharma announced new real-world preliminary data from the OPTION-VMS Phase IV study, indicating that fezolinetant is effective in treating moderate to severe vasomotor symptoms (VMS) associated with menopause, showing statistically significant improvements in various outcomes [1][2][5] Group 1: Study Findings - The OPTION-VMS study involved over 900 women aged 40-75 with confirmed menopausal VMS, demonstrating significant improvements in VMS bother, sleep quality, and work productivity [2][4][8] - Statistically significant reductions in Menopause-Specific Quality of Life (MENQOL) VMS domain scores were observed at weeks 4, 8, and 12, indicating enhanced quality of life for participants [5][6] - Improvements in sleep quality were measured using PROMIS SD SF 8b and objective sleep outcomes, including wakefulness after sleep onset (WASO) and sleep efficiency [3][5] Group 2: Safety and Efficacy - The incidence of treatment-emergent adverse events related to fezolinetant was low and consistent with previous clinical trials, with no new safety signals reported [2][5] - The study's preliminary safety findings will be presented at The Menopause Society, with full results expected after final analysis [2][5] Group 3: Economic Impact - Menopausal symptoms significantly impact women's work productivity, with around one-third of working women experiencing difficulties due to severe symptoms, leading to potential career changes or reduced work hours [6][7] - With an estimated 1.2 billion women expected to be peri- or post-menopausal by 2030, addressing menopause-related symptoms is increasingly important for both individual well-being and economic productivity [6][7] Group 4: Product Information - VEOZAH (fezolinetant) is a non-hormonal neurokinin 3 receptor antagonist approved in 45 countries, indicated for treating moderate to severe VMS due to menopause [9][7] - The drug works by modulating neuronal activity in the brain's temperature control center to reduce the intensity and frequency of hot flashes and night sweats [9]