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FDA Expands Spravato Approval for Major Depressive Disorder

August 4, 2020

The FDA has approved Janssen’s Spravato (esketamine) nasal spray along with an oral antidepressant for the treatment of depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior.

The approval was based on two phase 3 trials in which Spravato significantly reduced depressive symptoms within 24 hours, with some patients starting to respond after just four hours.

The FDA approved Spravato in March 2019 for adults with treatment-resistant depression (TRD), a subpopulation of MDD patients.  

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