ALPMF - Astellas' non hormonal therapy shows positive effect on hot flashes in late-stage trial

Astellas Pharma ([[ALPMF]]) announced that its investigational oral, nonhormonal compound, fezolinetant yielded positive topline results in two Phase 3 trials evaluating its effect in moderate to severe vasomotor symptoms (“VMS”) – i.e., hot flashes associated with menopause.Both SKYLIGHT 1™ and SKYLIGHT 2™ clinical trials have met all four co-primary endpoints with a statistically significant reduction in the frequency and severity of moderate to severe VMS from baseline at week 4 and week 12 in the fezolinetant arm vs placebo, the company said.Less than 2% of trial participants have experienced serious treatment-emergent adverse events with the most common being headache.The double-blinded and placebo-controlled studies evaluated 30 and 45 mg fezolinetant administered once-daily for the first 12 weeks followed by 40-week active treatment extension periods.As for data from the trial, in the recent earnings call, Naoki Okamura, Astellas CFO, said that the company expected to ‘make a real balanced disclosure.’

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Astellas’ non hormonal therapy shows positive effect on hot flashes in late-stage trial