Esketamine: Approved for MDD Monotherapy

Esketamine is first monotherapy for MDD with inadequate response to oral antidepressants, approved after a priority FDA review. Esketamine has been approved by the FDA as the first monotherapy for adults with major depressive disorder (MDD) who have not responded to at least two oral antidepressants. This significant approval is part of a broader effort to address treatment-resistant depression (TRD), which affects a substantial portion of the MDD population.

• Rapid efficacy demonstrated: Clinical trials showed that esketamine significantly improved depressive symptoms within 24 hours, with 22.5% of patients achieving remission by week 4 compared to 7.6% in the placebo group.
• Targeting treatment-resistant depression: Esketamine has shown superiority over traditional antidepressants, providing a 54% increased likelihood of remission in patients with TRD at 8 weeks. This treatment targets the glutamate neurotransmitter pathway, addressing an unmet need in depression management.
• Safety and administration considerations: Esketamine is available only through certified healthcare settings due to potential risks like sedation and misuse, ensuring safe administration under the Risk Evaluation and Mitigation Strategy Program.   Since its initial approval, esketamine has been administered to over 140,000 patients globally, supported by robust clinical and real-world data.  The FDA monotherapy approval further cements its position as a leading treatment for TRD.

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