Thursday, 12 October 2023 9 .00 - 17.30 h
The U.S. Food and Drug Administration (FDA) issued a new guidance to provide general considerations to sponsors developing psychedelic drugs. This is the first kind of FDA guidance that presents considerations for designing clinical trials for these substances. According to the agency, there has been growing interest in the therapeutic potential of psychedelic drugs such as the use for depression, post-traumatic stress disorder, substance use disorders and other conditions. However, "designing clinical studies to evaluate the safety and effectiveness of these substances presents a number of unique challenges that require careful consideration", the agency says.
Within the draft guidance, the term psychedelics refers to "classic psychedelics", typically understood to be drugs such as psilocybin and lysergic acid diethylamide (LSD) that act on the brain's serotonin system (5-HT2 agonists), as well as "entactogens" or "empathogens" such as methylenedioxymethamphetamine (MDMA). Comments can be submitted to the FDA by 25 August 2023.
The draft guidance describes basic considerations including trial conduct, data collection, patient safety and new drug application requirements. Psychedelic drugs may produce psychoactive effects such as mood and cognitive changes, as well as hallucinations. As a result, there is the potential for drug abuse, which is a drug safety issue that requires sufficient safety measures in place for preventing misuse. For substances that are currently Schedule I controlled (i.e. narcotics), activities also must comply with applicable Drug Enforcement Administration (DEA) requirements. The regulations for establishing effectiveness of psychedelic drugs are in principle 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 agency states.
More information is available in FDA´s draft guidance Psychedelic Drugs: Considerations for Clinical Investigations.