Convergence: Psychedelic drug development is ‘hot,’ but proceed with caution
MONTREAL – 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.”
Khera added that “regulators are more willing to listen” to sponsors that are interested in developing drugs in this space.
Florence Butlen, of the European Medicines Agency (EMA), who participated remotely, said interest in psychedelic drugs is growing in Europe as well. “I think it does trigger hopes, and we recognize that it is important to have this as a treatment option,” said Butlen, who works as a senior scientific specialist in psychiatry and mental health, and has a background in clinical psychiatry and neuroscience.
Butlen added that in September 2023 EMA issued a revised guideline on clinical investigation of medicinal products in the treatment of depression with a new section that addresses considerations for developing psychedelic medications to treatment major depressive disorder. Public comments on the guidance are open until the end of March 2024.
But there are challenges in designing clinical trials for psychedelic treatment. Butlen said that all 27 Member States in the EU have different requirements for running these trials, as these treatments are not subject to centralized procedures.
There are also unique considerations when designing trials for psychedelic drugs, Khera said.
“It is not about getting approval to run the clinical trial, we need to be thinking about the journey of the patient, how will they be treated? It is also important to think about abuse liability and safety monitoring,” Khera said.
Butlen agreed and said abuse potential is an important consideration. “We need to have a better understanding of the risks and benefits of the drug and the use of the drug in the clinical setting,” she said.
Both panelists encouraged companies to have an early dialogue with regulators if they are interested in developing drugs in the psychedelic space.
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