Benefit–risk assessment of esketamine nasal spray vs placebo in treatment‐resistant depression
Clinical Pharmacology & Therapeutics Oct 16, 2020
Katz EG, Hough D, Doherty T, et al. - Due to the limited utility of conventional antidepressants (ADs) in treatment‐resistant depression (TRD) and thie evidence of effectiveness and safety of esketamine nasal spray with oral ADs from phase 3 studies in patients with TRD, researchers sought to determine the treatment benefits vs risks of esketamine + AD vs AD + placebo as induction and maintenance treatment in TRD using data from five phase 3 studies. Findings suggest achievement of remission in 5–21 additional patients and response in 14–17 additional patients per 100 patients on esketamine + AD vs AD + placebo in induction therapy. In maintenance therapy, esketamine may result in 19–32 fewer relapses. In both cases, little difference was noted in serious or severe common AEs (primarily dissociation, vertigo, and dizziness). Findings infer a positive benefit–risk balance for esketamine + AD as induction and maintenance therapy in patients with TRD.
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