The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to the investigational compound esketamine (Janssen) for the treatment of major depressive disorder (MDD) with imminent risk for suicide.

The designation was supported by data from a Phase 2 clinical trial of esketamine in patients with MDD. Results were presented at the Society of Biological Psychiatry 71st Annual Scientific Meeting in May 2016. 

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Esketamine previously received its first Breakthrough Therapy designation in November 2013 for treatment-resistant depression. Phase 3 clinical trials for this potential indication are currently ongoing. If granted approval, esketamine would provide a completely new treatment approach for patients with MDD.

Esketamine, a non-competitive and subtype non-selective activity-dependent N-methyl-D-aspartate (NMDA) receptor antagonist, will be available as an intranasal formulation.  

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