The development of novel pharmaceuticals whose pharmacology is dependent on cannabinoid receptors is an increasingly active area of research and development. However, the confusing and conflicting legal status of cannabis and its active constituents can inhibit development, as companies encounter significant and unique barriers to approval and appropriate scheduling. Experiences with development and regulatory submission of other CNS-active drugs, including the development of the required abuse potential assessment, provide important precedents and models for cannabinoids.
Cannabis is not approved for therapeutic purposes by the FDA. As such, it remains listed as a Schedule I drug, which is the only schedule permitted by the Controlled Substances Act (CSA) for drugs considered to be of high dependence potential. Placement in Schedule I does not prevent research for therapeutic potential but it raises unique and burdensome requirements. Typically, all FDA-approved drug products with the same active entity are placed in the same schedule; however, cannabinoid based products are among the few exceptions with products placed in either the highly restrictive Schedule II (Syndros, Cesamet) and others in Schedule III (Marinol). For therapeutic drugs, CSA Schedule placement is related to abuse and other safety risks so that those posing the highest risks are placed in Schedule II and the lowest risks in Schedule V. In principle, a cannabinoid formulation that was determined to carry less risk still might be placed in Schedule IV like benzodiazepine-based antianxiety drugs, while Schedule V seems unlikely for reasons that will be discussed.
In this webinar, presenters will focus on the role of an abuse potential assessment (also referred to as the Controlled Substances Act 8-factor analysis) in the development of cannabinoid products and how it relates to the US scheduling process, and related interactions with the FDA and DEA.
Jack Henningfield, Ph.D., 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.
Daniel Wang, Senior Associate, PinneyAssociates
Daniel Wang supports our clients with research and analysis for a variety of projects including postmarketing surveillance, study reports, and literature reviews. He also supports the development and coordination of postmarketing and risk management surveillance programs, including contributing to reports based on surveillance from Internet and media monitoring, public use datasets, and proprietary datasets. Additionally, Dan contributes to PinneyAssociates’ science, policy, and marketing intelligence efforts.
Before joining PinneyAssociates in 2010, Daniel coordinated early phase clinical trials in oncologic drug development at the Hospital of the University of Pennsylvania. Daniel graduated from the University of Pennsylvania in 2008 with a Bachelor of Arts Degree in the biological basis of behavior.
Who Should Attend?
Mid and senior level professionals responsible for clinical and regulatory affairs and the clinical development of cannabinoid drug products.
Relevant areas of expertise include:
- Regulatory affairs
- Drug safety/pharmacovigilance
- Risk management
- Project management
- Clinical research
What You Will Learn
- The therapeutic potential for cannabinoids
- The U.S. Controlled Substances Act and the Final FDA Guidance to Industry on Assessment of Abuse Potential of Drugs
- The role of abuse potential assessment and the 8-factor analysis in drug scheduling and control
- The abuse potential of cannabis and its constituents including THC, CBD, and other terpenes
- Studies to assess abuse potential of cannabinoid products during the development cycle
- How to leverage assessment results to support appropriate scheduling and patient access
PinneyAssociates helps their pharmaceutical and consumer healthcare clients to reduce regulatory risk and enhance the commercial and public health value of their life sciences products. During the past 40 years, PinneyAssociates has advised and served with pharmaceutical companies, the National Institute on Drug Abuse, College on Problems of Drug Dependence, the FDA, and others in the development of comprehensive abuse potential assessment, tamper testing of abuse deterrent formulations, and risk management for CNS drugs.