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.
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