BRIEF—FDA recommendations aim to inform psychedelic drug development

Today, the US Food and Drug Administration published a new  draft guidance to highlight fundamental considerations to researchers investigating the use of psychedelic drugs for potential treatment of medical conditions, including psychiatric or substance use disorders.

This is the first FDA draft guidance that presents considerations to industry for designing clinical trials for psychedelic drugs.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.

They are being evaluated for use in the potential treatment of conditions such as depression, post-traumatic stress disorder, substance use disorders and other conditions.

However, designing clinical studies to evaluate the safety and effectiveness of these compounds presents a number of unique challenges that require careful 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 Dr Tiffany Farchione, director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research.