The Janssen Pharmaceutical Companies of Johnson & Johnson has reported positive results from two Phase III trials that evaluated the safety and efficacy of esketamine nasal spray to treat adult patients with major depressive disorder (MDD).
The pivotal double-blind, randomised, placebo-controlled, multi-centre ASPIRE I & II trials met their respective primary efficacy endpoint of a reduction in depressive symptoms at 24 hours after the first dose as measured under the Montgomery-Åsberg Depression Rating Scale (MADRS).
Esketamine nasal spray 84mg plus SOC showed significant reduction in both trials compared to placebo plus SOC in rapidly reducing symptoms of major depressive disorder.
In the studies, comprehensive SOC included initial hospitalisation and newly initiated antidepressant therapy of comprehensive SOC.
Janssen Research & Development Clinical Research senior director Carla Canuso said: “These data are particularly important because patients with major depressive disorder presenting with active suicidal ideation with intent constitute a psychiatric emergency that requires immediate intervention.”
In the Phase III Aspire I and Aspire II trials, more than 450 patients who had MDD and were at risk for suicide were randomised to receive esketamine or placebo.
Esketamine nasal spray plus SOC was found to be well tolerated in both the trials. The safety profile was also consistent across the two studies in patients with major depressive disorder.
Janssen Research & Development Neuroscience Therapeutic Area global head Husseini Manji said: “These are the first global clinical studies in this severely ill patient population, who are typically excluded from antidepressant treatment studies.
“The esketamine nasal spray development programme is a demonstration of that commitment and our recognition of the great unmet need among individuals with major depressive disorder who experience suffering from a serious, biologically-based disease which has a significant negative impact on various aspects of life.”
Esketamine is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist and has the potential to help restore synaptic connections in brain cells in people with MDD.
In May last year, Janssen Research & Development reported positive results from two Phase III clinical trials of Esketamine nasal spray in treating patients with treatment-resistant depression.