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

Sage Therapeutics’ Zulresso (brexanolone) Receives FDA’s Approval for Postpartum Depression (PPD)


  • 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

Click here to read full press release/ article | Ref: Sage Therapeutics | Image: Twitter