FRIDAY, May 31, 2019 (Pharmacist's Briefing) -- Esketamine nasal spray plus an oral antidepressant appears to be a safe and effective treatment for patients with treatment-resistant depression, according to a study published online May 21 in The American Journal of Psychiatry.
In a multisite phase 3 study, Vanina Popova, M.D., from Janssen Research and Development in Beerse, Belgium, and colleagues randomly assigned 227 adults with moderate to severe nonpsychotic depression and a history of nonresponse to at least two antidepressants in the current episode to treatment with either esketamine nasal spray (56 or 84 mg twice weekly) plus an antidepressant or an antidepressant plus placebo nasal spray.
Based on the 197 patients completing the 28-day treatment phase, the researchers found that changes in the Montgomery-Åsberg Depression Rating Scale were significantly greater than with antidepressant plus placebo at day 28. Furthermore, clinically meaningful improvement was seen in the esketamine-plus-antidepressant group at earlier time points. However, the esketamine-plus-antidepressant group also more frequently reported the five most common adverse events (dissociation, nausea, vertigo, dysgeusia, and dizziness) compared with patients in the antidepressant-plus-placebo arm. In the two groups, 7.0 and 0.9 percent of patients, respectively, discontinued the study drug due to an adverse event. In the esketamine-plus-antidepressant group, adverse events generally appeared shortly after dosing and resolved by 1.5 hours after dosing.
"Esketamine is expected to address an unmet medical need in this population through its novel mechanism of action and rapid onset of antidepressant efficacy," the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including Janssen, which manufactures esketamine and funded the study.