Assessment of Abuse Liability of Brain-Penetrant Compounds: Regulatory Environment, Challenges and Opportunities in View of the Current Opioid Epidemic

Abuse liability of a drug refers to its potential use in a non-medical situation for the positive psychoactive effects it produces through its Central Nervous System (CNS) activity.The assessment of the abuse liability/potential of a drug encompasses all properties of the drug (chemical, pharmacological, pharmacokinetics, usage and diversion history), and is part of the overall assessment of drug safety under the evaluation of a New Drug Application (NDA) in the U.S. or a Market Authorization Application (MAA) ex-U.S.