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

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 […]

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Esketamine Evaluated in MDD Patients at Imminent Risk for Suicide

Esketamine Evaluated in MDD Patients at Imminent Risk for Suicide

Janssen announced new findings from a Phase 2 study evaluating esketamine nasal spray in patients with major depressive disorder who were at imminent risk for suicide. The findings were published in the American Journal of Psychiatry. Esketamine nasal spray is an investigational glutamate receptor modulator that is thought to help restore synpatic connections in brain cells in patients […]