Navigating The Unique Attributes Of Psychedelic Drug Development

The draft FDA guidance released in June 2023 outlines regulatory requirements for psychedelic clinical trials and references key guidance on evaluating abuse and dependence potential. While the guidance permits the use of published data to meet regulatory prerequisites for certain psychedelics, sponsors are advised to scrutinize existing literature and identify essential gaps for inclusion in their IND and NDA submissions. In instances requiring additional data, it is crucial to tailor studies to accommodate the unique pharmacology of psychedelic drugs, ensuring data integrity and regulatory success.

This webinar will explore vital considerations in the clinical development of psychedelics, including the assessment of abuse potential using an Eight Factor Analysis (8FA). It will also discuss optimal strategies for clinical trials, covering aspects such as blinding, active control selection, and the role of facilitators.