Janssen's esketamine meets in Phase III to prevent treatment-resistant depression relapse

The Janssen Pharmaceuticals Inc. unit of Johnson & Johnson (NYSE:JNJ) said intranasal esketamine (formerly JNJ-54135419) plus an oral antidepressant met the primary endpoint of delaying time to relapse during maintenance treatment compared with an oral antidepressant alone in the Phase III SUSTAIN-1 trial to prevent relapse of treatment-resistant depression in adults (p=0.003). Data were presented at the International College of Neuropsychopharmacology meeting in Vienna.

The double-blind, international trial enrolled 705 patients who were stable remitters after 16 weeks of treatment with esketamine plus an oral antidepressant to either continue 56 or 84 mg esketamine once weekly or once every other week based on depressive symptoms or switch to placebo plus an oral antidepressant during maintenance treatment. Esketamine plus an antidepressant led to relapse during maintenance in 26.7% of patients vs. 45.3% of patients who received placebo plus an antidepressant (HR=0.49, 95% CI: 0.29, 0.84)...