RESEARCH I N T E R V I E W
Creating non-habit forming formulations and treatment protocols for psychedelic substances is crucial Despite challenges, there's increasing interest in the therapeutic potential of psychedelic substances, more so after the US FDA released its first draft guidance on psychedelic drug trials in June this year. In an email interaction with Viveka Roychowdhury, Dr Ronald Aung-Din, scientific advisor and Dr Aric Logdson, Scientific Director, Psycheceutical Bioscience detail the regulatory challenges and why Psycheceutical's NeuroDirect topical cream to be applied to the back of the neck at the hairline, currently undergoing a Phase I trial in Australia, offers an innovative way to reduce the complexity of delivering drugs across the blood-brain barrier What are the challenges of developing safe and nonhabit forming therapeutic use psychedelic compounds? Dr Aung-Din: One significant hurdle is navigating the regulatory landscape, as all psychedelic substances aside from ketamine are classified as Schedule I drugs, indicating a high potential for abuse and no recognised medical use. This classification often complicates the process of obtaining permissions for research and clinical trials. The legal status of these substances also contributes to a scarcity of comprehensive, quality research–making it difficult to fully grasp their effects, ideal dosages, and potential risks. Safety is another major concern. Psychedelic substances can sometimes trigger adverse reactions like severe anxiety or paranoia, necessitating the development of protocols to manage these risks, which could include careful screening procedures, supervised administration, and follow-up care. Standardisation and quality control of psychedelic substances is critical in
16 EXPRESS PHARMA November 2023
Dr Ronald Aung-Din
order to establish safety, efficacy, and appropriate dosages. Public perception is also a significant obstacle. The association of psychedelic substances with recreational use and abuse rather than medical treatment creates a stigma that can be hard to overcome.
Dr Aric Logdson
Finally, while many psychedelic substances aren't considered physically addictive, they have the potential for abuse through habit formation or psychological dependence. Therefore, creating nonhabit forming formulations and treatment protocols is crucial.
Despite these challenges, there's a surge of interest in the therapeutic potential of psychedelic substances. As our understanding of these substances expands, we inch closer to developing safe, effective, and non-habit forming treatments for various mental health conditions.
What is the mode of action of Psycheceutical's NeuroDirect delivery platform? Dr Aung-Din: Psycheceutical's NeuroDirect topical cream is applied to the back of the neck at the hairline to deliver neuroaffective compounds directly to the nervous