Astellas Reports P-III Study (SKYLIGHT 1) Results of Fezolinetant for Vasomotor Symptoms Due to Menopause
- The P-III study evaluating Fezolinetant (30 & 45mg, qd) vs PBO in a ratio (1:1:1) in 527 patients at 97 facilities across the USA, Canada, Czech Republic, Hungary, Poland, Spain & the UK
- The trial met its 4 coprimary efficacy EPs i.e., the therapy showed an improvement from baseline in VMS frequency & severity @4 & 12wks., improvements were seen as early as 1wk. & the effects were maintained at 52wk. study period, TEAEs (37% & 43% vs 45%). The study results were published in The Lancet
- The safety profile was observed during the 40wk. extension period was consistent with 12wk. PBO-controlled period. The 2EPs were mean change in PROMIS SD SF 8b total score from baseline to 12wks., improvements in sleep disturbance, statistical significance was not met for fezolinetant dose @12wks.
Ref: prnewswire | Image: Astellas
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