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FDA’s new draft guidance outlines key considerations for psychedelic drug development programs.
On June 23, 2023, FDA issued a new draft guidance concerning the use of psychedelic drugs for treatment of various medical conditions, including psychiatric and substance use disorders. For the purposes of the guidance, “psychedelic” describes 5-HT2 agonists, such as psilocybin and lysergic acid diethylamide, more commonly known as LSD, as well as entactogens or empathogens such as methylenedioxymethamphetamine (MDMA). According to an agency press release, this is the first FDA draft guidance that presents considerations to industry for designing clinical trials for psychedelic drugs.
“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, director, Division of Psychiatry, Center for Drug Evaluation and Research, FDA, in the release. “By publishing this draft guidance, the FDA hopes to outline the challenges inherent in designing psychedelic drug development programs and provide information on how to address these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.”
The document describes basic considerations throughout the drug development process including trial conduct, data collection, subject safety, and new drug application requirements. According to the guidance:
“Because this is an emerging area of drug development, there is limited experience as to the configuration of programs that may support approval of a psychedelic drug. Rather than providing specific recommendations on study design, this guidance will present foundational constructs that all sponsors, including academic sponsor-investigators, studying the therapeutic potential of psychedelic drugs should consider. Sponsors may also request meetings with FDA for advice on a specific drug development program” (1).
FDA is soliciting comments on the guidance until Aug. 23, 2023. The guidance in full can be read on the FDA site here.