29 Aug Psychedelic drug trial guidance: Commenters see vital role for psychotherapy

By Mary Ellen Schneider, Regulatory Focus

Commenters on the US Food and Drug Administration’s (FDA) first guidance on clinical investigations and drug development programs for psychedelic drugs raised concerns about decoupling drug administration from psychotherapy support, the proposed credentials for lead safety monitors and the agency’s characterization of the abuse potential of psychedelic drugs.

The draft guidance, issued in June 2023, outlines the nonclinical, clinical, and safety considerations of conducting trials for classic psychedelic agents, which include 5-HT2 agonists such as psilocybin and lysergic acid diethylamide (LSD) and methylenedioxymethamphetamine (MDMA). The guidance applies to trials conducted under an investigational new drug application (IND), including academic studies that are not designed to support marketing applications. Read more …