A Review of the Food and Drug Administration Pipeline and Proposed California Legislation on Medicinal Psychedelics.

Psychedelic and empathogenic compounds hold therapeutic potential but are expensive and complex to study, with significant safety concerns. This review examines eight late-phase medicinal psychedelic studies in the FDA approval pipeline, including the FDA's denial of Lykos Therapeutics' New Drug Application for MDMA-assisted psychotherapy for PTSD. It also discusses California legislative proposals to legalize psychedelic compounds for adult use as a cheaper alternative, though these proposals lack thorough drug safety evaluation. The authors argue that the FDA should remain the appropriate agency to evaluate and approve these therapeutics.

Study at a glance

Abstract

Psychedelic and empathogenic compounds show promise for a variety of conditions. However, studying these compounds can be highly complex, be very expensive, and have substantial patient safety concerns. Here, the authors will review 8 late-phase medicinal psychedelic studies in the Food and Drug Adminisration (FDA) approval pipeline. The authors will include a review of the FDA's recent denial of the New Drug Application for 3-4-methylenedioxymethamphetamine with adjuvant psychotherapy for posttraumatic stress disorder from Lykos Therapeutics of San Jose, California (formerly the Multidisciplinary Association for Psychedelic Studies Public Benefit Corporation). Additionally, the authors will discuss the parallel legislative proposals in California to legalize psychedelic compounds for adult use. These legislative efforts reflect an alternative and less expensive pathway, but they do not make as thorough of an evaluation for drug safety. The authors will propose that the FDA remains the appropriate agency to evaluate and approve the use of this class of proposed therapeutics.