FDA Committees Vote on Esketamine Nasal Spray for Treatment-Resistant Depression

The Food and Drug Administration (FDA)’s Psychopharmacologic Drug Advisory Committee and Drug Safety and Risk Management Advisory Committee voted in favor (14 yes, 2 no, 1 abstain) of the approval of esketamine nasal spray (Spravato; Janssen) for the treatment of adult patients with treatment-resistant depression (TRD).

The decision was based on data from five Phase 3 studies assessing the safety and efficacy of esketamine, a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist; patients in these studies had a history of inadequate response to least 2 prior antidepressants and generally had more severe symptoms than those who participated in antidepressant studies for previously approved drugs.

Results from 2 of these Phase 3 studies (1 short-term, 1 long-term), which primarily provided the evidence to support effectiveness, showed that treatment with esketamine nasal spray plus a newly initiated oral antidepressant was associated with a statistically significant, clinically meaningful, rapid, and sustained improvement of depressive symptoms vs

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