The US Food and Drug Administration (FDA) has expanded the approval of esketamine nasal spray (Spravato; Johnson & Johnson), allowing its use as monotherapy for adults with major depressive disorder who have not responded adequately to at least two oral antidepressants.
This decision is backed by a double-blind, randomized, placebo-controlled trial that demonstrated “rapid and superior” improvement in Montgomery-Asberg Depression Rating Scale (MADRS) scores. Notably, 22.5% of patients receiving esketamine nasal spray achieved remission (MADRS total score ≤ 12) at 4 weeks, compared with only 7.6% in the placebo group.
“Now that it is also available as a monotherapy, healthcare providers have the freedom to further personalize treatment plans based on individual needs, so patients can experience the efficacy of Spravato in as little as 24 hours, through day 28, without the need for a daily oral antidepressant,” said Gregory Mattingly, MD, of St. Charles Psychiatric Associates and Midwest Research Group.
Clinicians should note that the safety profile of esketamine monotherapy mirrors that observed with combined oral antidepressant use. Due to the potential risks for sedation, dissociation, and abuse or misuse, it remains available only under a restricted Risk Evaluation and Mitigation Strategy (REMS).
