Janssen files for new US indication for Spravato

A supplemental New Drug Application (sNDA) has been submitted to the US Food and Drug Administration seeking a new indication for Spravato (esketamine) CIII nasal spray for the rapid reduction of depressive symptoms in adult patients with major depressive disorder (MDD) who have active suicidal ideation with intent, says the drug’s developer Janssen, part of US healthcare giant Johnson & Johnson (NYSE: JNJ).

The submission is based on results from the Phase III ASPIRE I & II trials, which evaluated the efficacy and safety of Spravato versus placebo nasal spray in this high-risk patient population when used in addition to comprehensive standard of care (SOC). In these studies, comprehensive SOC included initial hospitalization and newly initiated and/or optimized antidepressant therapy.

"This submission is a significant step in helping a vulnerable patient population by providing a potential treatment option to rapidly reduce symptoms of depression in adults with active suicidal ideation with intent, which constitutes a psychiatric emergency that requires immediate intervention," said Dr Husseini Manji, global head, neuroscience therapeutic area, Janssen Research & Development, adding: "It extends our focus on severe manifestations of major depressive disorder beyond the current indication for treatment-resistant depression."