The US Food and Drug Administration (FDA) last week published its first-ever draft guidance for clinical trials investigating psychedelic drugs for potential treatments for medical conditions.
In a statement, the agency noted that there has been growing interest in the therapeutic potential of psychedelic drugs in recent years with these substances being evaluated as potential treatments for a range of conditions, including depression, post-traumatic stress disorder (PTSD), and substance use disorder.
Designing clinical trials to evaluate the safety and efficacy of psychedelic compounds presents unique challenges that require careful consideration, the FDA said.
As such, the agency said the purpose of the draft guidance is to advise researchers on study design and other considerations as they develop medications containing psychedelics.
It describes basic considerations throughout the drug development process, including trial conduct, data collection, subject safety, and new drug application requirements.
It also addresses the role of psychotherapy in psychedelic drug development, considerations for safety monitoring, and the importance of characterizing dose-response and the durability of any treatment effect.
“By publishing this draft guidance, the FDA hopes to outline the challenges inherent in designing psychedelic drug development programs and provide information on how to address these challenges,” said Dr. Tiffany Farchione, the director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research, in a statement.
“The goal is to help researchers design studies that will yield interpretable results that will be capable of supporting future drug applications.”
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