Intranasal esketamine spray succeeded in preventing a relapse of treatment-resistant depression, results of two trials sponsored by the drug's manufacturer suggest.
Only 26.7% of adult patients in stable remission receiving esketamine spray plus an oral antidepressant for 16 weeks had a relapse in depressive symptoms during a maintenance phase, compared with 45.3% of those on an oral antidepressant plus a placebo nasal spray (P=0.003), Janssen reported.
the high incidence of dissociation with esketamine's use could ultimately be a barrier to approval.
Currently, esketamine has been granted breakthrough therapy status by the FDA for treatment-resistant depression and for major depressive disorder with imminent risk for suicide. Janssen announced plans to submit all the results from the studies for approval. "If approved by the FDA, esketamine would be one of the first new approaches to treat refractory major depressive disorder available to patients in the last 50 years," the company stated.