Psychedelic drug development is receiving more attention lately as these treatments offer the potential for needed therapeutic alternatives for various mental health conditions, yet developers need to take care in designing trials and balancing risk profiles, according to panelists speaking at RAPS Convergence 2023.
The psychedelic space has been “pretty hot for the past four years,” said Aman Khera, of Worldwide Clinical Trials, Canada, a contract research organization. “Companies are thinking about how to develop these products.”
In June 2023, the US Food and Drug Administration (FDA) issued its first guidance for drug development programs and clinical investigations evaluating psychedelic drugs to treat conditions such as substance use and psychiatric disorders (RELATED: FDA issues first psychedelic drug trial guidance, Regulatory Focus 28 June 2023). Khera said the guidance has been helpful for industry “to think about what things we ought to be considering when undertaking clinical research in this field.”…
