Just weeks after Janssen announced that it had submitted an NDA for its intranasal esketamine for the treatment of depression, the company has presented data from a Phase 3 trial of the nasal spray that failed to meet its primary endpoint. Positive results from a previous Phase 3 study were published in May 2018.
The new data from a study that enrolled 346 adults with treatment-resistant depression and compared 56 and 84 mg doses of esketamine nasal spray to placebo failed to demonstrate a statistically significant improvement in depression severity after 4 weeks for the higher dose. Data for the lower dose and for the secondary endpoints were excluded from formal evaluation due to failure of the higher dose.
However, according to Janssen, “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.”
Janssen Global Head, Neuroscience Therapeutic Area, Husseini K. Manji said, “Together with the recently announced results from four other Phase 3 studies, these data provide continued support for a positive benefit-risk assessment for esketamine nasal spray as a potentially novel treatment approach for patients living with treatment-resistant depression. One-third of patients with major depressive disorder do not respond to existing therapies, and they need new treatment options.”
Read the Janssen press release.
