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Sage Therapeutics' SAGE-217 Receives FDA's Breakthrough Designation for CNS Disorders

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Sage Therapeutics' SAGE-217 Receives FDA's Breakthrough Designation for CNS Disorders

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  • The FDA’s BT Designation is based on P-II study assessing SAGE-217 vs PBO in 89 patients with moderate to severe major depressive disorder (MDD)
  • The P-II study results: met 1EPs; reduction in the Hamilton Rating Scale for Depression (HAM-D); safe- effective & well tolerated data
  • SAGE-217 (qd- PO) is an allosteric modulator targeting synaptic & extrasynaptic GABA receptors used for regulating CNS function and is currently developed for MDD- Parkinson’s disease and sleep disorders

Ref: Sage Therapeutics | Image: Twitter

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