Phase III success for Janssen’s esketamine in treatment-resistant depression

Janssen has presented data from pivotal Phase III clinical studies backing use of esketamine spray in treatment-resistant depression.

The nasally-administered drug is a non-competitive and subtype non-selective activity-dependent N-methyl-D-aspartate (NMDA) receptor antagonist, offering a new mechanism of action from currently available therapies for depression.

Maintenance data show 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.

Also, patients in stable remission treated with esketamine nasal spray plus an oral antidepressant reduced the risk of relapse by 51 percent compared to patients receiving an oral antidepressant plus placebo nasal spray, the firm noted.

The five most frequently reported adverse events in the esketamine-treated patients (>5 percent) during the maintenance phase were temporary impaired sense of taste, vertigo, dissociation, drowsiness, and dizziness.

A long-term safety study 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).

According to Janssen, 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".

"Major Depressive Disorder affects nearly 300 million people of all ages globally and is the leading cause of disability worldwide, 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."