J&J Seeks Spravato as Monotherapy in Depression

Johnson & Johnson has filed a supplemental NDA seeking approval of Spravato (esketamine) nasal spray as monotherapy for adults living with treatment-resistant depression (TRD). “Many patients living with challenging-to-treat depression spend far too long cycling through multiple treatments that don't effectively resolve their symptoms, which can cause a significant functional and emotional burden on patients and their loved ones,” the company says.

The submission is based on “positive” data from the Phase 4 TRD4005 study that showed a rapid change in Montgomery-Asberg Depression Rating Scale total score as early as 24 hours after the first Spravato dose and sustained through at least four weeks of treatment, J&J says.

Currently, Spravato is approved for combination use with an oral antidepressant for treating adults with TRD and depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior.