Pharmaceutical Executive June 25, 2023
First guidance in this area from the Agency addresses the unique challenges when designing clinical studies for these drugs
The FDA published its first draft guidance that presents considerations to industry for designing clinical trials for psychedelic drugs.1 In the guidance, the FDA says the term psychedelic includes classic psychedelics, typically understood to be 5-HT2 agonists such as psilocybin and lysergic acid diethylamide (LSD), as well as entactogens or empathogens such as methylenedioxymethamphetamine (MDMA).2
Psychedelics have been evaluated as therapies for a number of conditions including depression, post-traumatic stress disorder, and substance use disorders. The challenges associated with designing clinical studies to evaluate the safety and effectiveness psychedelics is why FDA issued the guidance.
“Psychedelic drugs show initial promise as...
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