Johnson & Johnson (NYSE:JNJ) unit Janssen Pharmaceutical Companies has filed a supplemental marketing application in Europe, called a Type II variation, seeking approval to use Spravato (esketamine) nasal spray as an acute short-term treatment, together with oral antidepressant therapy, for the rapid reduction of depressive symptoms in adults experiencing a moderate-to-severe depressive episode of major depressive disorder (MDD) who have suicidal ideation with intent.
Spravato is currently approved (December 2019) in the EU for adults with treatment-resistant MDD, in combination with an SSRI or SNRI, who have not responded to at least two different treatments with antidepressants in the current moderate to severe depressive episode.
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