Positive Results Announced for Esketamine in Treatment-Resistant Depression

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First-of-its-kind study conducted in elderly patients with treatment-resistant depression
First-of-its-kind study conducted in elderly patients with treatment-resistant depression
The following article is part of conference coverage from the 2018 American Psychiatric Association (APA) Annual Meeting in New York, New York. Psychiatry Advisor's staff will be reporting breaking news associated with research conducted by leading experts in psychiatry. Check back for the latest news from APA 2018.

Janssen announced positive results from two Phase 3 studies evaluating esketamine nasal spray in patients with treatment-resistant depression (defined as patients who have not responded to ≥2 antidepressants of adequate dose and duration in the current episode of depression). In both studies, the primary efficacy endpoint was change from baseline to Day 28 in Montgomery-Åsberg Depression Rating Scale (MADRS) total score.

In a study evaluating adults with treatment-resistant depression (N=223), flexibly dosed esketamine nasal spray (56mg or 84mg) added to a newly initiated oral antidepressant was associated with a statistically significant, clinically meaningful rapid reduction of depressive symptoms vs placebo nasal spray plus a newly initiated oral antidepressant (least squares [LS] mean difference -4.0, 95% CI: -7.31, -0.64; P =.010). 

A second study in elderly patients (≥65 years) with treatment-resistant depression (N=138) found that flexibly dosed esketamine nasal spray (28mg, 56mg or 84mg) added to a newly initiated oral antidepressant led to clinically meaningful effects vs placebo nasal spray plus a newly initiated oral antidepressant (median unbiased estimate of difference from placebo -3.6, 95% CI: -7.20, 0.07; P =.029), however, the study did not reach statistical significance for its primary efficacy endpoint. 

"With about 30% of patients with major depression failing to respond to currently available antidepressants, treatment-resistant depression represents a major public health need," said Husseini K. Manji, MD, Global Head, Neuroscience Therapeutic Area, Janssen Research & Development, LLC. "The positive Phase 3 results for esketamine nasal spray in adults with treatment-resistant depression are exciting, particularly as they mark the first time an antidepressant has achieved superiority versus an active comparator in any clinical trial for major depressive disorder." 

Esketamine is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist. The drug has received Breakthrough Therapy Designations for both treatment-resistant depression and major depressive disorder with imminent risk for suicide.

For more information visit Janssen.com.

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