Post‐approval analysis finds favorable safety for esketamine nasal spray
The Brown University Psychopharmacology Update November 28, 2025 DOI: 10.1002/pu.31391 via OpenAlex
Summary
AI-generated from the abstractAn analysis of nearly five years of post-approval safety data for esketamine nasal spray found no new safety concerns associated with the formulation. Most adverse events occurred during the first treatment session, and their incidence decreased over the course of treatment. The results were published online on Sept. 10, 2025, in the American Journal of Psychiatry.
Study at a glance
| Characteristics | Analysis of post-approval safety data Peer reviewed |
|---|---|
| Intervention | Esketamine nasal spray |
| Duration | Nearly five years |
| Key finding | 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 .