The U.S. Food and Drug Administration (FDA) has published a new draft guidance the agency noted focuses on considerations to researchers investigating psychedelic drugs for potential treatment of medical conditions.
“Psychedelic drugs show initial promise as potential treatments for mood, anxiety and substance use disorders,” FDA Center for Drug Evaluation and Research Division of Psychiatry Director Dr. Tiffany Farchione said. “However, these are still investigational products. Sponsors evaluating the therapeutic potential of these drugs should consider their unique characteristics when designing clinical studies. “By publishing this draft guidance, the FDA hopes to outline the challenges inherent in designing psychedelic drug development programs and provide information on how to address these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.”
Farchione said the goal is to help researchers design studies that yielding interpretable results capable of supporting future drug applications.
According to the FDA, the draft guidance offering serves as the first presenting considerations to industry for designing clinical trials for psychedelic drugs. There has been growing interest in the therapeutic potential of psychedelic drugs in recent years.
Psychedelic drugs are being evaluated for use in the potential treatment of conditions that include depression, post-traumatic stress disorder, substance use disorders and other conditions.
Designing clinical studies to evaluate the safety and effectiveness of the compounds presents a number of unique challenges requiring careful consideration.
The document describes basic considerations throughout the drug development process that include trial conduct; data collection; subject safety; and new drug application requirements, the FDA noted.