Comment on FDA's Breakthrough Therapy Designation of Intranasal Esketamine for the Treatment of Major Depressive Disorder with Imminent Risk of Suicide

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This comment addresses the FDA's decision to grant breakthrough therapy designation to esketamine for major depressive disorder, particularly with an immediate risk of suicide.
Analyzed FDA's rationale for breakthrough therapy designation.
Discussed potential implications of intranasal esketamine on treatment protocols.
Evaluated existing clinical evidence supporting esketamine's efficacy.
Breakthrough designation may expedite access to esketamine for patients in acute need.
Initial findings suggest esketamine could significantly reduce suicidal ideation.
Discussion highlights the importance of timely and effective intervention in severe depression cases.

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Comment discusses FDA designation of intranasal esketamine for treating major depression with suicide risk, suggesting potential benefits.

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Thomas et al. (2016) studied this question.

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