The Janssen Pharmaceutical Companies of Johnson & Johnson presented for the first time in Europe data from pivotal Phase 3 clinical studies of the investigational compound esketamine nasal spray in treatment-resistant depression.
The studies, conducted by Janssen Research & Development, LLC, were presented at the 31st International College of Neuropsychopharmacology (CINP) congress in Vienna, Austria. Data discussed from the Phase 3 programme included results from the maintenance phase of a long-term relapse prevention study in adults with treatment-resistant depression.
The data found that continuing treatment with esketamine nasal spray plus an oral antidepressant in patients beyond 16 weeks showed clinically meaningful and statistically significant superiority to treatment with an oral antidepressant plus placebo nasal spray in delaying time to relapse of symptoms of depression. Furthermore, the data indicated that patients in stable remission treated with esketamine nasal spray plus an oral antidepressant reduced the risk of relapse by 51% (estimated Hazard Ratio = 0.49; 95% CI: 0.29, 0.84) compared to patients in the oral antidepressant plus placebo nasal spray group.
The five most frequently reported adverse events in the esketamine-treated patients (>5%) during the maintenance phase were temporary impaired sense of taste, vertigo, dissociation, drowsiness, and dizziness.
Professor Siegfried Kasper, Head of the Department of Psychiatry and Psychotherapy at the Medical University of Vienna, Austria said, “These data provide insights related to the safety of esketamine in patients with treatment resistant depression over the long-term and show that esketamine may be beneficial in terms of extending time to relapse in a patient population that is challenging to treat.”
Mathai Mammen, M.D, Ph.D., Global Head, Janssen Research & Development, LLC said “We are pleased to share these results from our Phase 3 program for esketamine nasal
spray. They reinforce its potential to help patients who haven’t responded to available