Esketamine nasal spray filed with EMA for major depressive disorder.- Janssen Pharma.

Janssen Pharma has submitted a marketing application to the European Medicines Agency seeking approval of nasally-delivered spray esketamine for the treatment of major depressive disorder. Esketamine has been developed for treatment-resistant depression in adults with MDD who have not responded to at least two different treatments with antidepressants in the current moderate-to-severe depressive episode.

The application follows an earlier filing to the FDA based on five pivotal Phase III studies of esketamine nasal spray in patients with treatment-resistant depression: three short-term studies, one withdrawal maintenance of effect study, and one long-term safety study. Data from these studies demonstrate that treatment with esketamine nasal spray plus a newly initiated oral antidepressant compared to placebo nasal spray plus a newly initiated antidepressant was associated with rapid reduction of depressive symptoms and delayed time to relapse of symptoms of depression. The long-term safety study showed that the esketamine doses studied were generally tolerated, with no new safety signals with dosing up to 52 weeks, compared to data from the short-term esketamine studies. The short-term esketamine Phase III study in adults with treatment-resistant depression included a newly initiated oral antidepressant in both the control and placebo groups.