Strategies for Assessing Abuse Liability of CNS Drugs

This white paper outlines strategies for drug development sponsors to assess the abuse liability of brain-penetrant compounds during the drug development process. It details the legal and regulatory frameworks relevant to the assessment, including the criteria for scheduling drugs under the Controlled Substances Act. The document emphasizes the importance of integrating abuse potential assessments into the overall development strategy and highlights the need for early engagement with the FDA's Controlled Substance Staff. It describes the complexities involved in conducting Human Abuse Potential studies, including the challenges of study design and execution. The paper also discusses the independent processes of FDA approval and DEA scheduling, noting the timeline improvements established by the Improving Regulatory Transparency for New Medical Therapies Act. Additionally, it provides recommendations for sponsors on key meetings and data presentations necessary for successful NDA submissions, ensuring compliance with regulatory expectations.