Bayer Reports Positive Results From Two Pivotal Phase III Studies For Elinzanetant

(RTTNews) - Bayer reported positive top-line results of the Phase III studies OASIS 1 and 2 evaluating the efficacy and safety of the investigational compound elinzanetant versus placebo. The company said Elinzanetant met all four primary endpoints in both studies showing statistically significant reductions in the frequency and severity of moderate to severe vasomotor symptoms from baseline to week 4 and 12 compared to placebo. Both studies achieved all three key secondary endpoints. The safety profile was overall consistent with previously published data.

Bayer plans to submit data from the OASIS 1, 2 and 3 studies to health authorities for approval of marketing authorizations for treatment of moderate to severe vasomotor symptoms associated with menopause. The results of the third Phase III study OASIS 3 is expected in the coming months.

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