ADVERTISEMENT
FDA Releases First Draft Guidance on Psychedelic Clinical Trials
On Friday, the US Food and Drug Administration (FDA) released a new draft guidance aimed at researchers exploring the use of psychedelic drugs for potential medical treatments. This marks the first FDA draft guidance that provides considerations to the field for designing clinical trials involving psychedelic drugs.
Tiffany Farchione, MD, FAPA, director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research, emphasized the initial promise of psychedelic drugs 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,” Dr Farchione said in a news 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 “By publishing this draft guidance, the FDA hopes to outline the challenges inherent in designing psychedelic drug development programs and provide information on how to address these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.”
READ>>First Psilocybin Service Center in Oregon Receives License
The draft guidance advises researchers on essential considerations, such as study design, as they develop medications containing psychedelics. It specifically addresses “classic psychedelics,” 5-HT2 agonists that act on the brain’s serotonin system, such as psilocybin and lysergic acid diethylamide (LSD), as well as entactogens or empathogens like methylenedioxymethamphetamine (MDMA).
The document covers various considerations throughout the drug development process, including trial conduct, data collection, subject safety, and new drug application requirements.
Given that psychedelic drugs can induce psychoactive effects and hallucinations, there is a need to carefully consider and implement safety measures to prevent misuse during clinical development, the FDA said. The draft guidance also emphasizes compliance with applicable Drug Enforcement Administration (DEA) regulations for psychedelics classified as Schedule I controlled substances.
“The evidentiary standard for establishing effectiveness of psychedelic drugs is the same as for all other drugs. However, there are unique factors investigators may need to consider when designing their clinical trials if those trials are to be considered adequate and well-controlled,” the FDA said in its release.
The draft guidance also addresses the role of psychotherapy in psychedelic drug development, safety monitoring considerations, and the significance of characterizing dose-response and treatment durability.
The FDA encourages the public to comment on the draft guidance within 60 days to ensure that all perspectives are considered before finalizing the guidance.
Reference
