Esketamine nasal spray Phase III study fails in treatment-resistant depression

Janssen Pharmaceutical, a unit of healthcare giant Johnson & Johnson (NYSE: JNJ) has revealed that its, esketamine nasal spray in patients with treatment-resistant depression failed to demonstrate a statistically valid treatment effect compared to placebo in a late-stage trial.

The study did not demonstrate statistical significance for the primary endpoint, change in a depression severity rating scale score from baseline to four weeks, for esketamine 84mg plus oral antidepressant compared to oral antidepressant plus placebo. Therefore, based on the pre-specified analysis plan, the esketamine 56 mg plus oral antidepressant group could not be formally evaluated in this study.

Importantly, results of analyses of the primary endpoint and key secondary endpoints numerically favored both esketamine plus oral antidepressant treatment groups over the oral antidepressant plus placebo group.