Sage Plans New Trials And Approval Timeline For Zuranolone
Company Will Explore A Higher Dose For The Antidepressant
Sage will initiate three new trials to support FDA approval of the drug for post-partum depression and major depressive disorder, with data anticipated in 2021.
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The company will cut 340 positions, primarily affecting Zulresso commercial operations, to save $170m, after announcing it will need to run new trials to support the regulatory plan for zuranolone.
The company said it will update investors on the path forward for zuranolone in major depressive disorder after finalizing discussions with the US FDA. It would not confirm if a meeting had taken place yet.
Sage Therapeutics points to patient compliance and selection as factors in its failed trial of SAGE-217. The company sees positive implications in the data as it waits for other SAGE-217 studies.