- A systematic review and meta-analysis questioned the clinical efficacy of esketamine nasal spray for treatment-resistant depression and suicidal ideation.
- The FDA approval of esketamine was based on unconventional approaches, raising concerns about its effectiveness.
- The medication is currently administered under a Risk Evaluation and Mitigation Strategy, which requires in-clinic self-administration and monitoring.
- Postapproval surveillance data showed mixed results, with no increase in the reporting odds ratio for suicide attempt but increases in suicidal ideation and depression.
- The editorial emphasized the importance of studying how esketamine compares with newer adjunctive medications and neuromodulation treatments for future research needs.
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Esketamine Efficacy Questioned 6 Years Following Approval
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