FDA releases draft guidance for clinical development of psychedelic drugs

Key Takeaways

• The guidance outlines considerations throughout the drug development process.
• Because of the potential for misuse, the FDA said careful consideration of safety is essential.

The FDA has released draft guidance for researchers investigating psychedelic drugs as a potential treatment for medical conditions such as psychiatric or substance use disorders.

“Psychedelic drugs show initial promise as potential treatments for mood, anxiety and substance use disorders. However, these are still investigational products,” Tiffany Farchione, MD, director of the division of psychiatry in the FDA’s Center for Drug Evaluation and Research, said in a press release from the FDA. “Sponsors evaluating the therapeutic potential of these drugs should consider their unique characteristics when designing clinical studies.”

The draft guidance is intended to outline basic considerations for trial conduct, data collection, subject safety and new drug application requirements for classic psychedelics, such as psilocybin and lysergic acid diethylamide, and entactogens, such as methylenedioxymethamphetamine.

Because of the potential for these drugs to be abused, careful consideration of subject safety measures is essential throughout the clinical development of psychedelic treatments, the FDA said in the release.

The draft guidelines require that data from the abuse potential assessment and a proposal for drug scheduling under the Controlled Substances Act be included in a new

drug application submission. The guidelines also state that studies involving Schedule I controlled substances must comply with Drug Enforcement Administration regulations.

Two monitors should observe for safety monitoring throughout the duration of treatment under the guidelines. If subjects for clinical trials that are conducted under an investigational new drug application are found to have been exposed to unreasonable risk, the FDA may place the study under clinical hold. The guidelines also say that informed consent must be obtained from subjects with the understanding that they may experience changes in perception, cognition, judgment, vulnerability and suggestibility.

Reference:

• Psychedelic Drugs: Considerations for Clinical Investigations Guidance for Industry. https://www.fda.gov/media/169694/download. Published June 2023. Accessed June 28, 2023.