The US Food and Drug Administration has expanded the approval of esketamine, a ketamine-derived nasal spray, for use as monotherapy in adults with treatment-resistant depression (TRD). Initially approved in 2019 for use in combination with oral antidepressants for TRD, the drug was later approved for treating depressive symptoms in adults with major depressive disorder and acute suicidal ideation or behavior. Clinical evidence In a clinical trial involving TRD patients aged 19 to 76, esketamine significantly improved Montgomery-Åsberg Depression Rating Scale (MADRS) total scores from baseline compared to placebo (-11.4 vs.
-6.3) at week 28. Notably, by week 4, 22.5% of patients receiving esketamine achieved remission compared to 7.6% of those on placebo. Dosage and administration Intranasally under the supervision of a healthcare provider Induction Phase o Weeks 1 to 4:…
