Conference Coverage

Esketamine nasal spray prevails in two phase 3 trials


 

FROM THE ASCP ANNUAL MEETING

The combination of an esketamine nasal spray and an oral antidepressant may provide additional benefits for patients with treatment-resistant major depressive disorder, new research suggested.

Two posters at a meeting of the American Society of Clinical Psychopharmacology, formerly known as the New Clinical Drug Evaluation Unit meeting, presented data from two phase 3 studies on the safety and efficacy of an esketamine nasal spray plus oral antidepressant in patients with treatment-resistant depression.

The first study – a double-blind, randomized withdrawal study – enrolled 705 patients with recurrent or single episode major depressive disorder who were either enrolled directly or after completing the double-blind phase of an acute, short-term study.

Patients began with a 16-week induction phase of esketamine nasal spray and oral antidepressant, then patients were randomized either to a placebo nasal spray or esketamine nasal spray – plus oral antidepressant – for the maintenance phase.

Researchers saw a significantly higher rate of relapse among patients randomized to the placebo nasal spray, compared with those randomized to the esketamine nasal spray. In patients classified as stable remitters at the start of the maintenance period, 26.7% of those who received the esketamine nasal spray experienced a relapse, compared with 45.3% of those who received the placebo nasal spray.

Among the stable responders, 25.8% of those who received esketamine experienced a relapse, compared with 57.6% of those who received the placebo nasal spray.

This represented a 51% lower risk of relapse with esketamine among stable remitters and a 70% lower risk of relapse among stable responders, compared with placebo. Treatment with esketamine also significantly delayed relapse, compared with placebo.

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