Janssen Research & Development has reported positive results from two Phase III clinical trials of Esketamine nasal spray in treating patients with treatment-resistant depression.
In one of the trials, adults with treatment-resistant depression were randomised to flexibly-dosed esketamine nasal spray combined with a newly initiated oral antidepressant, or placebo nasal spray added to a newly initiated oral antidepressant.
The double-blind, active-control trial was conducted at 39 sites in the Czech Republic, Germany, Poland, Spain and the US.
The trial’s primary efficacy endpoint includes change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score.
Findings from the trial have shown statistically significant clinical improvement in patients’ depressive symptoms from esketamine nasal spray along with an oral antidepressant at day 28.
The trial identified ‘treatment-resistant’ as patients who had not responded to two or more currently available antidepressants of adequate dose and duration in the current episode of depression.
The second trial was a double-blind, multicenter, active-controlled study that included elderly patients aged 65 and older with treatment-resistant depression.
Results from the trial have demonstrated that treatment with flexibly dosed esketamine plus a newly initiated oral antidepressant demonstrated clinically meaningful effects compared to placebo nasal spray plus a newly initiated oral antidepressant.
The trial, however, narrowly missed statistical significance for its primary efficacy endpoint.
Janssen Research & Development Neuroscience Therapeutic Areaglobal head Husseini Manji said: “With about 30% of patients with major depression failing to respond to currently available antidepressants, treatment-resistant depression represents a major public health need.”
Esketamine is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist, also known as a glutamate receptor modulator, which has the potential to help restore synaptic connections in brain cells in people with a major depressive disorder.