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.
The Controlled Substances Act (CSA) describes eight factors that need to be examined in order to assess the abuse potential of substances that are active within the central nervous system (CNS). These factors encompass a wide range of topics regarding the substance, including the totality of its physical and behavioral effects, consequences to the individual and public health, its availability, and use patterns. The results of this analysis are a required part of any FDA submission for a product with CNS activity and is the basis for the government’s scheduling decisions.
During this webinar, Jack Henningfield, PhD, Vice President, Research, Health Policy, and Abuse Liability, PinneyAssociates, will provide an overview of the history and regulations surrounding scheduling and control of cannabis and cannabinoid-based products. Reginald Fant, PhD, Director, Clinical Pharmacology and Abuse Potential Assessment, PinneyAssociates, will review the types of studies that need to be conducted during the development process of a cannabinoid-based product and strategies to best characterize its abuse potential.
PinneyAssociates is a pharmaceutical and consumer healthcare consulting company that helps clients to reduce their regulatory risk and enhance the commercial and public health value of their life sciences products. PinneyAssociates consults with companies that market a wide variety of prescription and over-the-counter medications. PinneyAssociates’ experts have extensive expertise in abuse-deterrent drug formulation evaluation, abuse potential assessment, as well as pharmaceutical risk management, tobacco harm reduction, and Rx-to-OTC switch.
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