06/27/2023
Photo by Anastasiya Dalenka on Unsplash
The US Food and Drug Administration issued a draft guidance on “Psychedelic Drugs: Considerations for Clinical Investigations” in June 2023. Psychedelics are a new horizon development potential in clinical trials. As more sponsors and sponsor-investigators move towards psychedelic drug development as a new psychiatric therapy, questions arise about the best way to move forward within the regulatory framework for clinical trials. Psychedelics are considered to be drugs by the FDA and as such the same regulations apply as for traditional drug development. However, due to the complex nature of psychedelics, there are additional considerations to address when designing and conducting those clinical trials.
A summary of the draft guidance recommendations are:
Chemistry, Manufacturing, and Controls that adequately ensure the identification, quality, purity, and strength of the investigational drug substance and drug product
If the drug may be considered a botanical as defined in the 2016 guidance Botanical Drug Development
If the botanical is modified or compounds are extracted, it is considered a drug product
Psychedelics must still follow GMP regulatory requirements
Nonclinical program that follows the ICH M3(R2) guideline
Determination of the dosing regimen
Conduct repeat dose toxicity studies
Evaluation of binding to serotonin receptor sites including assessment of functional activity at the 5-HT2B receptor subtype
Evaluation of changes to the heart valves if the drug is an agonist at 5-HT2B receptors
Consideration if an IND is required and what information should be included
Clinical pharmacology that adequately describes the pharmacokinetics and/or pharmacodynamics of the psychedelic investigational drug
Assessment of high fat meals for oral drugs
Assessment of Drug-Drug and Drug-Disease interactions
Interactions with 1) SSRIs or MAO inhibitors that may diminish effects and 2) lithium or tricyclics that may potentiate effects
Dose response relationship characterization for safety and efficacy
Abuse potential assessment after therapeutic dose range is established
Safety assessments including abuse related AEs
Assessment for dependence
Clinical trials following the same regulatory requirements as for drug studies
Evaluation of responses should used validated scales
Comment now through August 23, 2023 HERE.
There is one notable difference compared to most clinical trial investigational products: “For psychedelic drugs that are Schedule I controlled substances, activities associated with investigations under an IND must comply with the applicable Drug Enforcement Administration (DEA) regulations for research, manufacturing, importation/exportation, handling, and storage requirements for a Schedule I drug.” “Should a psychedelic drug that is a Schedule I controlled substance receive FDA approval as a drug product, the abuse potential assessment would assist in determining an appropriate rescheduling action under the Controlled Substances Act.”
Do you work in clinical trials involving psychedelics? We would love to hear from you about your experience!
- The Clinical Pathways Team
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