A Review of the Food and Drug Administration Pipeline and Proposed California Legislation on Medicinal Psychedelics.
The Permanente journal March 14, 2025 Jack R Watson, Laura Halpin, Violeta Barroso et al. 2 citations
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.