Journal
EPIDEMIOLOGY AND PSYCHIATRIC SCIENCES
Volume 29, Issue -, Pages -Publisher
CAMBRIDGE UNIV PRESS
DOI: 10.1017/S2045796019000751
Keywords
Esketamine; evidence-based medicine; FDA; regulatory policies; treatment-resistant depression
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In March 2019, the US Food and Drug Administration (FDA) approved a nasal spray formulation of esketamine for the treatment of resistant depression in adults. Esketamine is the S-enantiomer of ketamine, an FDA-approved anaesthetic, known to cause dissociation and, occasionally, hallucinations. While ketamine has not been approved for depression in the USA or in any other country, it has been used off-label in cases of severe depression. This commentary critically reviewed the evidence on esketamine submitted to the FDA, aiming to draw implications for clinical practice, research and regulatory science.
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