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 companies will seek approval for zuranolone in MDD second-half 2022 and in PPD in first-half 2023, but that also means launch will probably happen second-half 2023.
Before pivotal depression data in 2021 attempt to redeem zuranolone after a failed Phase III study, the company will report Phase II results for next-gen GABA modulator SAGE-324 in essential tremor.
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.