Esketamine Efficacy Questioned 6 Years Following Approval
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March 4, 2025
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4 min
A systematic review and meta-analysis published in the American Journal of Psychiatry raised doubts about the clinical efficacy of esketamine nasal spray for treatment-resistant depression and suicidal ideation. It highlighted modest effect sizes, lack of controlled long-term efficacy data, and negligible evidence for efficacy against suicidality. The FDA's approval of esketamine was based on unconventional approaches and raised concerns about the medication's effectiveness and potential withdrawal effects.
1. A systematic review and meta-analysis questioned the clinical efficacy of esketamine nasal spray for treatment-resistant depression and suicidal ideation. 2. The FDA approval of esketamine was based on unconventional approaches, raising concerns about its effectiveness. 3. The medication is currently administered under a Risk Evaluation and Mitigation Strategy, which requires in-clinic self-administration and monitoring. 4. Postapproval surveillance data showed mixed results, with no increase in the reporting odds ratio for suicide attempt but increases in suicidal ideation and depression. 5. 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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