The late-stage randomized trial evaluated two fixed doses of esketamine – 56 mg and 84 mg along with an oral antidepressant in comparison to placebo plus oral antidepressant.
Janssen revealed that treatment with esketamine 84 mg plus oral antidepressant could not show any statistical significance for the primary endpoint of the trial in comparison to oral antidepressant plus placebo.
The primary endpoint was defined as change in a depression severity rating scale score from baseline to four weeks, for esketamine 84 mg plus oral antidepressant in comparison to oral antidepressant plus placebo.
As a result of the findings, Janssen said that based on the prespecified analysis plan, it could not formally assess the esketamine 56 mg plus oral antidepressant group in the trial.
However, the company said that results of analyses of the primary endpoint and key secondary endpoints numerically favored esketamine plus oral antidepressant treatment groups in comparison to the oral antidepressant plus placebo group.
Commenting on the phase 3 results of the depression medication esketamine nasal spray, Husseini K. Manji – Global Head, Neuroscience Therapeutic Area, Janssen Research & Development, 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.”
Earlier this month, Janssen filed a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for esketamine, seeking the regulator’s approval to use its depression medication for treatment-resistant depression in adults.
The esketamine NDA is supported by results of five pivotal phase 3 studies of the depression medication in patients with treatment-resistant depression.
As per the data from the five trials, esketamine along with a newly initiated oral antidepressant was associated with quick reduction of depressive symptoms and delayed time to relapse of symptoms of depression compared to placebo plus a newly initiated antidepressant.
Esketamine, which is a glutamate receptor modulator, is believed to help restore synaptic connections in brain cells in patients suffering from major depressive disorder. The Janssen depression medication is claimed to function differently than currently available treatment for major depressive disorder.
Esketamine was granted Breakthrough Therapy Designations by the US FDA for treatment-resistant depression and also for a major depressive disorder with imminent risk for suicide.
Recently, Janssen had secured marketing authorization for daratumumab from the European Commission (EC) as initial therapy for for multiple myeloma in a certain type of patient population.