FDA Unveils First Draft Guidance on Psychedelic Drug Clinical Trials

Recently, the Food and Drug Administration (FDA) released for the first time a new draft guidance regarding clinical trials involving psychedelic drugs. These guidelines are meant to provide considerations to researchers exploring the use of psychedelic drugs for possible treatment of medical conditions, including substance use or psychiatric disorders (1).

Over the years, therapeutic potential of psychedelic drugs has grown in interest and are now being evaluated to be used to treat health conditions such as post-traumatic stress disorder (PTSD), substance use disorders, depression, and various other ailments. It has been challenging though to form clinical studies needed to help figure out the effectiveness and safety of these drugs which bring unique challenges that need consideration.

“Psychedelic drugs show initial promise as potential treatments for mood, anxiety and substance use disorders. However, these are still investigational products. Sponsors evaluating the therapeutic potential of these drugs should consider their unique characteristics when designing clinical studies,” said Tiffany Farchione, M.D., director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research (1). “By publishing this draft guidance, the FDA hopes to outline the challenges inherent in designing psychedelic drug development programs and provide information on how to address these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. The goal is to help researchers design studies that will yield interpretable results that will be capable of supporting future drug applications.”

FDA’s draft guidance is meant to be used to offer recommendations to researchers on how to design their studies and other considerations that need to be looked at while they begin to create medication that include psychedelics. The document provides guidance throughout the drug development process such as data collection, subject safety, trial conduct, and new drug application requirements. Mentioned in the draft guidance is “that activities associated with investigations under an Investigational New Drug Application must comply with applicable Drug Enforcement Administration regulatory requirements,” (1).

To read more on the FDA’s psychedelics draft guidance, click here (2).

References

1. FDA issues First Draft Guidance on Clinical Trials with Psychedelic Drugs https://www.fda.gov/news-events/press-announcements/fda-issues-first-draft-guidance-clinical-trials-psychedelic-drugs (accessed Jun 28, 2023).
2. Guidance for Industry https://www.fda.gov/regulatory-information/search-fda-guidance-documents/psychedelic-drugs-considerations-clinical-investigations (accessed Jun 28, 2023).