Esketamine for treatment resistant depression: a trick of smoke and mirrors?

Epidemiol Psychiatr Sci. 2019 Dec 16;29:e79. doi: 10.1017/S2045796019000751.

Abstract

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.

Keywords: Esketamine; FDA; evidence-based medicine; regulatory policies; treatment-resistant depression.

MeSH terms

  • Adult
  • Antidepressive Agents / administration & dosage
  • Antidepressive Agents / therapeutic use*
  • Depression / diagnosis
  • Depression / drug therapy*
  • Depressive Disorder, Treatment-Resistant / diagnosis
  • Depressive Disorder, Treatment-Resistant / drug therapy*
  • Drug Approval
  • Evidence-Based Medicine
  • Humans
  • Infusions, Intravenous
  • Ketamine / administration & dosage
  • Ketamine / therapeutic use*
  • United States
  • United States Food and Drug Administration

Substances

  • Antidepressive Agents
  • Esketamine
  • Ketamine