Developing Psychedelics Into Medicine: Potential and Pitfalls

Psychedelics, a class of powerful psychoactive substances that alter perception and cognition, have largely been relegated to illicit recreational substances after laws in the 1960s banned their use. This class of drugs includes LSD, psilocybin (magic mushrooms), and MDMA (commonly known as ecstasy). However, in the past 20 years, led by researchers at major universities such as Johns Hopkins University and Imperial College London, there has been a renewed interest in studying these substances for their therapeutic effects. Studies have been conducted showing the potential for psychedelics to treat conditions such as anxiety, depression, and substance use disorders with effects that last longer and feature fewer side effects than their mainstream treatments.

Development of these compounds into approved medications will require sizable efforts from sponsors to not only assess these compounds for efficacy in treatment, but also their abuse potential and safety. It is necessary to consider a systematic approach to abuse potential assessment that can be conducted alongside the typical CNS drug development when working on these compounds. Nonclinical safety assessments and human data from early trials can be useful to collect early on. Additionally, data from clinical studies can further characterize the therapeutic benefits of these drugs in relation to their risk of abuse and addiction. FDA’s recent designation of a psilocybin medicine as a Breakthrough Therapy signaled the seriousness with which it is taking psychedelic medicines as it clearly seems to be poising itself for a pipeline of such drugs.

In this webinar, presenters will outline necessary steps and considerations for development of psychedelics into medicinal therapies.

Topics will include:

• Potential for psychedelics in the treatment of psychiatric conditions
• Studies for assessment of abuse potential, from nonclinical to clinical
• Practical application of FDA guidance on Assessment of Abuse Potential of Drugs
• Regulatory timelines and abuse potential assessment

Speakers

Sidney H. Schnoll, MD, PhD, Vice President, Pharmaceutical Risk Management Services, PinneyAssociates

Sidney (Sid) Schnoll is an internationally recognized expert in addiction and pain management who applies his experience of over 30 years in academic medicine to the issues of risk management. Sid counsels clients on regulatory and scientific strategy, and development, implementation and assessment of risk management activities, including engagement with the FDA. Sid leads efforts to conduct risk assessment during early product development, develop Risk Evaluation and Mitigation Strategies (REMS), and develops post-marketing surveillance reports for submission to FDA.

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David Heal PhD, DSC, FBPhS, FRSC, Executive Director, Consultancy Services and Drug Abuse Evaluation, RenaSci Ltd

David Heal is an internationally recognized expert in the field of monoamine neurotransmitters and their role in pharmacological actions of CNS-active drugs to treat a range of disorders including ADHD, binge-eating disorder, depression, obesity, and schizophrenia. Research into the monoaminergic pharmacology of a range of substances of abuse has been the major focus using techniques like in vivo microdialysis combined with behavioural measurements, drug-discrimination and self-administration to investigate the neurochemistry of their therapeutic mechanisms, actions and recreational abuse. David has a long history of interaction with the FDA on scientific and drug development topics. During his career in the pharmaceutical industry and with RenaSci, he has helped to support the successful registration of 12 CNS drugs.

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Jack E. Henningfield, PhD, Vice President, Research, Health Policy, and Abuse Liability, PinneyAssociates

Jack E. Henningfield is one of the world’s leading experts on addiction, and the behavioral, cognitive, and central nervous system (CNS) effects of drugs. He headed clinical pharmacology and abuse potential assessment at the National Institute on Drug Abuse (NIDA) where his responsibilities included Controlled Substances Act (CSA) abuse potential and drug scheduling recommendations. His NIDA Clinical Pharmacology laboratories conducted pioneering assessments of cannabis abuse potential and effects. He counsels clients on assessment of the abuse liability of new CNS-acting drugs and formulations, evaluation of potential application of the Controlled Substances Act to new products, assessment of the tamper resistance of novel formulations, and development of risk management approaches. Jack frequently liaises with the Food and Drug Administration on issues concerning drug scheduling and addiction, and has presented frequently to FDA Advisory Committees. He has contributed to numerous comments to FDA on topics including prescribing of opioids for chronic pain, development and regulation of abuse-deterrent opioid formulations, and abuse potential assessment.

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