The FDA published a new draft guidance to highlight fundamental considerations to researchers investigating the use of psychedelic drugs for potential treatment of medical conditions, including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 guidance was created in response to growing interest in the therapeutic potential of psychedelic drugs in recent years, particularly for conditions such as depression, post-traumatic stress disorder, substance use disorders and other conditions.
Recent developments in psychedelic therapies include:
- FDA approval of ketamine for treatment-resistant depression in 2019
- Positive Phase 3 clinical trials for MDMA in the treatment of PTSD
- The launch of Phase 3 clinical trials for psilocybin in treatment-resistant depression
- Johns Hopkins University establishing a center for psychedelic research, which later received a $4 million federal grant
This new guidance is the first FDA draft guidance that presents considerations to industry for designing clinical trials for psychedelic drugs. The document describes basic considerations throughout the drug development process including trial conduct, data collection, subject safety, and new drug application requirements.
For psychedelics that are currently Schedule I controlled substances, the draft guidance notes that activities associated with investigations under an Investigational New Drug Application must comply with applicable Drug Enforcement Administration regulatory requirements.
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 The draft guidance also addresses the role of psychotherapy in psychedelic drug development, considerations for safety monitoring and the importance of characterizing dose-response and the durability of any treatment effect.
The FDA is encouraging the public to provide comments on the draft guidance. Comments should be submitted within 60 days to ensure the agency considers them.
