The US FDA Approves sNDA for J&J’s Spravato (esketamine) to Treat Major Depressive Disorder (MDD)
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
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
Click here to read the full press release
Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
