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Post‐approval analysis finds favorable safety for esketamine nasal spray

The Brown University Psychopharmacology Update November 28, 2025 DOI: 10.1002/pu.31391 (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Analysis of post-approval safety data Peer reviewed
Intervention Esketamine nasal spray
Duration Nearly five years
Topics Esketamine
Key points No new safety concerns were uncovered for esketamine nasal spray, and most adverse events occurred during the first treatment session, with incidence decreasing over time.

Abstract

Nearly five years of post‐approval safety data for esketamine nasal spray have uncovered no new safety concerns associated with the formulation, an analysis has found. Most adverse events occurred during the first treatment session, with incidence decreasing over the course of treatment. Results were published online Sept. 10, 2025, in the American Journal of Psychiatry .