The confusing and conflicting legal status of cannabis and its active constituents can inhibit product development as companies encounter significant and unique barriers to approval and appropriate scheduling. In a complementary webinar, Jack Henningfield, Ph.D., and Daniel Wang described how the development and regulatory submission of other CNS-active drugs, including the development of the FDA-required abuse potential assessment, provide important precedents and models for cannabinoids.
“Product form and composition are important determinants of scheduling and potential claims. An early assessment can help avoid late stage surprises that add time and cost to development.” – Jack Henningfield
In the case of cannabinoids, an abuse potential assessment, conducted in accordance with the 2017 FDA Guidance on Assessment of Abuse Potential of Drugs, would consider the source of the active ingredients, the content and strength of active ingredients, the route of administration, any subjective effects, and whether the formulation can be manipulated or tampered. These factors can be indicative of the likelihood of diversion and dependence. From a health policy perspective, second hand exposure to the constituents of cannabinoid products would also be important.
The webinar will be available until March 2019 at https://xtalks.com/webinars/cannabinoid-abuse-potential-assessment-the-8-factor-analysis/.