10 October 2018 - Data from five pivotal Phase 3 studies submitted as the basis for marketing authorisation application for esketamine nasal spray.

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a marketing authorisation application to the EMA seeking approval for esketamine nasal spray, a glutamate receptor modulator, for treatment-resistant depression in adults with major depressive disorder who have not responded to at least two different treatments with antidepressants in the current moderate to severe depressive episode.

The application is based on five pivotal Phase 3 studies of esketamine nasal spray in patients with treatment-resistant depression: three short-term studies, one randomised withdrawal and maintenance of effect study, and one long-term safety study. Data from these Phase 3 studies demonstrated that treatment with esketamine nasal spray plus a newly initiated oral antidepressant, compared to an active comparator (newly initiated antidepressant plus placebo nasal spray), was associated with rapid reduction of depressive symptoms, as early as day 2, and reduced the risk of relapse by 51% in stable remitters.4,5 The long-term safety study showed that the esketamine nasal spray doses studied were generally tolerated, with no new safety signals in dosing up to 52 weeks, comparable to the data from the short-term esketamine nasal spray studies.

Read Janssen press release