Shots:
- The US FDA has approved sNDA for Spravato CIII nasal spray to treat MDD patients unresponsive to at least two oral antidepressants, following the FDA Priority Review
- Approval was based on a multicenter trial that assessed Spravato vs PBO, showing an improved MADRS total score. In a post-hoc analysis, Spravato improved all 10 MADRS items by day 28 & achieved remission (MADRS ≤12; 1EP; 22.5% vs 7.6%) in 4wks with consistent safety
- Spravato (s-enantiomer of ketamine) is a non-competitive NMDA receptor antagonist with an unclear MoA used for treating treatment-resistant depression (TRD)
Ref: J&J | Image: J&J
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