How the Food and Drug Administration Drug Approval Process Relates to the Potential Approval of Intravenous Racemic Ketamine for Treatment-resistant Major Depression.
Journal of psychiatric practice March 1, 2024 Sheldon H Preskorn
Intravenous racemic ketamine, which contains both R-ketamine and S-ketamine (esketamine), is not yet FDA-approved for treatment-resistant major depressive disorder. The FDA's typical drug approval process requires three phases: normal volunteer studies, small-scale proof-of-concept trials, and large-scale registration trials that establish efficacy, safety, and tolerability in real-world clinical use. While small academic studies and clinical use abroad supported the unique value of lithium and clozapine for bipolar disorder and treatment-resistant schizophrenia, leading to advocacy and eventual registration trials, comparable registration trials for intravenous racemic ketamine remain to be done. Safety concerns addressed in esketamine's registration trials have not been similarly studied for intravenous racemic ketamine.