Esketamine Nasal Spray Shows Promise Depression Relapse

New results from a couple of long-term phase 3 clinical trials report the investigational compound esketamine nasal spray is efficacious and safe in delaying relapse time for patients with treatment-resistant depression.

The research, from Janssen Pharmaceutical Companies of Johnson & Johnson, assessed esketamine nasal spray plus oral antidepressant versus placebo plus oral antidepressant in delaying time to relapse of depression symptoms in patients who suffer from treatment-resistant depression. It follows 2 studies presented at the American Psychiatric Assocation's Annual Meeting in New York, NY, las week, which showed the drug's efficacy in short-term duration.

The findings are significant both for the drug — which is being considered for US Food and Drug Administration (FDA) — and for a worldwide patient population of more than 300 million. The therapy is a glutamate receptor modulator, considered capable of restoring synaptic connections in the brains of patients with depression. Its novel mechanism of action gives it distinction among a limited market of available or effective antidepressant treatments for this patient population. According to Janssen, the common “full antidepressant effect” provides relief after 3-4 weeks.

The first trial, a randomized, double-blind, multi-center study of 705 adult patients directly enrolled or transferred from previous esketamine phase 3 trials, compared 56 or 84 mg nasal spray plus oral antidepressant versus a placebo-antidepressant regimen in intermittent dosing over 16 weeks.

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