New indication for Spravato authorized in Europe

8 February 2021
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The European Commission (EC) has authorized the expanded use of Spravato (esketamine nasal spray), co-administered with oral antidepressant therapy in adults with a moderate to severe episode of major depressive disorder (MDD), as acute short-term treatment, for the rapid reduction of depressive symptoms, which according to clinical judgement constitute a psychiatric emergency.

Johnson & Johnson (NYSE: JNJ) subsidiary Janssen’s esketamine nasal spray is already authorized by the EC for use in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI), for adults with treatment-resistant major depressive disorder (TRD), who have not responded to at least two different treatments with antidepressants in the current moderate to severe depressive episode.

Clinical backing

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