On Friday, U.S. Food and Drug Administration (FDA) released its first draft guidance on the conduct of clinical trials for psychedelic drugs. The Draft Guidance for Industry, Psychedelic Drugs: Considerations for Clinical Investigations, if finalized, will guide researchers investigating psychedelics as potential treatments for medical conditions.
There has been significant media, marketing, and legislative interest in the therapeutic potential of psychedelic drugs for conditions like depression, post-traumatic stress disorder, and substance use disorders. FDA reminds those interested in using and researching psychedelic compounds that these drugs, like all others, are subject to the same regulations and evidentiary standards for approval and patient use as any other drugs under development. FDA also notes that these compounds, including “classic psychedelics” such as psilocybin and lysergic acid diethylamide (LSD), and “entactogens” or “empathogens” like methylenedioxymethamphetamine (MDMA), present unique challenges for designing clinical studies. For example, the draft guidance points out that psychedelic drugs have unique risk profiles that can cause intense perceptual disturbances and alterations in consciousness that can last for several hours.
FDA recognizes that this is an “emerging area of drug development” and therefore there is limited experience in configuring a program that could support the approval of psychedelic drugs. Thus, the draft guidance does not provide specific recommendations on study design. Instead, FDA presents foundational principles that drug development sponsors (academic and non-academic) should consider when developing a clinical program for the study of the therapeutic potential of psychedelic drugs. Sponsors may also request meetings with FDA to discuss their study and/or its design.
Key aspects in the draft guidance include trial conduct, data collection, subject safety, and investigational new drug (IND) application requirements. FDA cautions that the potential for misuse of these psychoactive drugs necessitates robust safety and security measures during clinical development.
Comments on the draft guidance are due August 25, 2023.
The OFW Cannabis Team is prepared to assist you. Please contact Tish Pahl (tpahl@ofwlaw.com), Kyla Kaplan (kkaplan@ofwlaw.com), or Ben Dash (bdash@ofwlaw.com) with any questions.
