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Janssen Phase 3 Study Programme of Esketamine Nasal Spray in Patients with Treatment-Resistant Depression Presented for the First Time in Europe

Janssen
Posted on: 19 Jun 18

BEERSE, Belgium--(BUSINESS WIRE)--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.1,2,3,4 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.1

A long-term safety study of esketamine nasal spray showed that in adults with treatment-resistant depression, esketamine nasal spray plus an oral antidepressant was generally well tolerated with no new safety signals identified after repeated long-term dosing for up to one-year (52 weeks). The safety profile of esketamine was similar to that observed in previous short-term Phase 2 and 3 studies in patients with treatment-resistant depression. The data from this open-label study also indicated that treatment with esketamine nasal spray plus an oral antidepressant appeared to be associated with sustained improvement in depressive symptoms for up to 52 weeks. The most common treatment-emergent adverse events (≥10% patients) were dizziness, dissociation, nausea, headache, drowsiness, temporary impaired sense of taste, diminished oral sense of touch or sensation, vertigo, vomiting, and viral upper respiratory tract infection.2

“Major Depressive Disorder affects nearly 300 million people of all ages globally and is the leading cause of disability worldwide,5 therefore it is important we continue to study and report the results of these studies in this area,” said Professor Siegfried Kasper, Head of the Department of Psychiatry and Psychotherapy at the Medical University of Vienna, Austria. “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.”

Two additional esketamine short-term randomised, double blind, active-controlled studies, one in adults and one in in patients aged 65 years or over, were also presented at CINP.3,4

In the first study in adults with treatment-resistant depression, flexibly dosed esketamine nasal spray plus a newly initiated oral antidepressant demonstrated a statistically significant, clinically meaningful, rapid reduction of depressive symptoms compared to placebo nasal spray plus a newly initiated oral antidepressant. This study showed that treatment with esketamine plus an antidepressant achieved superiority versus an active comparator, which is considered clinically meaningful, especially in patients deemed to be treatment-resistant. The most common treatment-emergent adverse events reported (>10% of patients) in the esketamine group were temporary impaired sense of taste, nausea, vertigo, dizziness, headache, drowsiness, short lived perceptual changes, blurred vision, paresthesia (tingling sensation) and anxiety. The most common treatment-emergent adverse events (>10% of patients) reported in the oral antidepressant plus placebo group were temporary impaired sense of taste and headache.3

In a second study in elderly patients aged 65 years or older with treatment-resistant depression – a patient cohort that is historically hard to treat – treatment with flexibly dosed esketamine plus a newly initiated oral antidepressant demonstrated a clinically meaningful effect compared to a newly initiated oral antidepressant plus placebo nasal spray, although statistical significance was not reached. Esketamine was generally well tolerated in the study. The most common treatment-emergent adverse events reported (>10% of patients) in the esketamine group were dizziness, nausea, headache, fatigue, increased blood pressure, vertigo, and dissociative and perceptual changes. There were no treatment-emergent adverse events reported in >10% of patients in the oral antidepressant and placebo group.4

“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 therapies,” said Mathai Mammen, M.D, Ph.D., Global Head, Janssen Research & Development, LLC. “We look forward to submitting all results from our esketamine treatment-resistant depression studies to regulatory authorities, with a view to bringing a new treatment option to people in need.”

Editor's Details

Mike Wood
PharmiWeb.com
www.pharmiweb.com
editor@pharmiweb.com

Last updated on: 19/06/2018

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