Johnson & Johnson's Janssen discloses phase 3 study results of Esketamine
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced results from a Phase 3 clinical study of the investigational product esketamine nasal spray in patients with treatment-resistant depression. Janssen researchers presented these results at the Ninth Biennial Conference of the International Society for Affective Disorders (ISAD) and the Houston Mood Disorders Conference, taking place September 20-22, 2018 in Houston, TX. This clinical trial was a randomized, double-blind study of two fixed doses of esketamine, 56 mg and 84 mg. 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 84 mg plus oral antidepressant compared to oral antidepressant plus placebo. Therefore, based on the prespecified 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.