Data on Efficacy, Tolerability of Esketamine Presented at Psych Congress
ORLANDO, Fla.— Data on esketamine nasal spray, focusing on efficacy, tolerability, and predictors of response and remission, were presented in 4 poster abstracts at Psych Congress 2018.
Esketamine is an investigational, rapidly acting antidepressant that works differently than treatments currently approved for depression. Janssen Pharmaceuticals has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval to use it for treatment-resistant depression (TRD) in adults.
One study presented at Psych Congress examined long-term antidepressant effects of esketamine, which has had its short-term efficacy demonstrated in other studies.
In the study, adults with TRD first took esketamine (56 or 84 mg) and an oral antidepressant for 16 weeks. Patients who achieved stable remission or, separately, response without remission were randomized to either continue the same treatment, or continue the same antidepressant and switch to a placebo nasal spray.
Among the stable remitters, 24 patients (26.7%) in the esketamine/antidepressant group later relapsed, compared with 39 patients (45.3%) in the placebo/antidepressant group.
For the stable remitters, the median time-to-relapse in the placebo/antidepressant group was 273 days. The median for the esketamine/antidepressant group was not estimable (50% relapse rate not reached based on Kaplan-Meier estimates).
The most common adverse events (incidence 20.4–27.0%) in the esketamine/antidepressant group during the maintenance phase were dysgeusia, vertigo, dissociation, somnolence, and dizziness, each of which were reported in less than 7% of patients in the placebo/antidepressant group.
“This study demonstrated that continued treatment with esketamine nasal spray plus antidepressant leads to significant, clinically meaningful superiority compared to antidepressant alone for relapse prevention among patients with TRD and provides further safety data regarding longer-term treatment,” researchers concluded.
Another study presented—1 of 5 included in the NDA—evaluated short-term efficacy of esketamine.
Participants were adults with moderate-to-severe depression who had not responded to 2 or more antidepressants in the current depressive episode. They were randomized to an oral antidepressant and 56 or 84 mg of esketamine or an oral antidepressant and a placebo nasal spray.
A mixed-effects model for repeated measures was used to assess the change from baseline to Day 28 in the total score on the Montgomery-Asberg Depression Rating Scale (MADRS). The results numerically favored both esketamine groups over the placebo group.
However, the difference between the esketamine 84 mg group and the placebo group was not statistically significant. As a result, in accordance with the predefined testing sequence, the significance of the difference between the esketamine 54 mg group and the placebo group could not be formally evaluated.