Astellas: Phase 3b Trial Shows Positive Topline Results for Menopause Symptoms

 Study evaluated 24-week efficacy and safety of Astellas' fezolinetant in women considered unsuitable for hormone therapy

Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced positive topline results from the Phase 3b DAYLIGHT clinical trial for fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause.

The study, comprised of more than 450 women considered unsuitable for hormone therapy, met the primary objective showing statistically significant reduction from baseline in the frequency of moderate to severe VMS to week 24 for fezolinetant 45 mg once daily versus placebo. Serious treatment emergent adverse events (TEAE) occurred in less than 5% of patients, and the most common TEAEs were COVID-19 and headache. Detailed results will be submitted for publication and for consideration at an upcoming medical meeting.

https://www.biospace.com/article/releases/phase-3b-trial-of-fezolinetant-shows-positive-topline-results-for-treatment-of-vms-due-to-menopause/