FDA Approves First Monotherapy Standalone MDD Treatment: Daily Dose

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Patient Care brings primary care clinicians a lot of medical news every day—it’s easy to miss an important study. The Daily Dose provides a concise summary of one of the website's leading stories you may not have seen.

Last week, we reported on on the US FDA approval of a supplemental New Drug Application (sNDA) for esketamine (Spravato; Johnson & Johnson) CIII nasal spray as the first and only monotherapy for adults with major depressive disorder (MDD) who have not responded adequately to at least 2 oral antidepressants.

The approval

Esketamine is a nonselective, noncompetitive antagonist of the N-methyl-D-aspartate (NMDA) receptor, targeting the glutamate pathway. The approval follows an FDA Priority Review and is based on data showing that esketamine alone demonstrated rapid and superior improvement in depressive symptoms compared with placebo, beginning as early as 24 hours and meeting its primary endpoint at 4 weeks.

In the randomized, double-blind, placebo-controlled study, esketamine led to statistically significant reductions in Montgomery-Åsberg Depression Rating Scale (MADRS) total scores by day 28. A post-analysis revealed numerical improvements across all 10 MADRS items, and remission (MADRS ≤12) at week 4 was achieved by 22.5% of patients who received esketamine vs 7.6% of those in the placebo group. The safety profile of esketamine as monotherapy remained consistent with established clinical and real-world safety data, and no new concerns were identified.

Because of the potential for sedation, dissociation, respiratory depression, and misuse, esketamine can be prescribed only through the Spravato Risk Evaluation and Mitigation Strategy (REMS) Program.

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