FDA Issues Draft Guidance on Clinical Trials for Psychedelic Drugs

Public comment on the draft proposal will be collected for the next 60 days.

The U.S. Food and Drug Administration released draft guidelines to aid scientists studying the therapeutic potential of psychedelic drugs, marking an updated direction in the regulation of clinical trials for these substances.

The new guidelines, intended for industries researching medical applications of psychedelics, underscored the unique challenges presented by these compounds in terms of safety and efficacy.

“Psychedelic drugs show initial promise as potential treatments for mood, anxiety and substance use disorders. However, these are still investigational products,” Tiffany Farchione, director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research, said in a statement.

The draft guidelines reference both “classic psychedelics,” such as psilocybin and lysergic acid diethylamide (LSD), that operate on the brain’s serotonin system, and “entactogens” or “empathogens” such as methylenedioxymethamphetamine (MDMA).

According to the document, investigators must be aware of the potential for abuse due to the psychoactive effects of these substances, such as mood and cognitive changes and hallucinations, and must implement safety measures to prevent misuse throughout clinical development, particularly for psychedelics that are currently listed as Schedule I controlled substances.

Alongside the safety considerations, the guidelines present trial conduct, data collection, and new drug application requirements – providing detailed assistance to researchers regarding the drug development process.

The guidelines also touch upon the role of psychotherapy in psychedelic drug development, safety monitoring considerations, and the significance of characterizing dose-response and the longevity of any treatment effect.

“The goal is to help researchers design studies that will yield interpretable results that will be capable of supporting future drug applications,” Farchione said.

The agency will collect public comments on the draft guidance over the next 60 days.


Adam Jackson

Adam Jackson writes about the cannabis industry for the Green Market Report. He previously covered the Missouri Statehouse for the Columbia Missourian and has written for the Missouri Independent. He most recently covered retail, restaurants and other consumer companies for Bloomberg Business News. You can find him on Twitter at @adam_sjackson and email him at adam.jackson@crain.com.

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