Strategies for Assessing Abuse Liability of CNS Drugs

This guide outlines strategies for drug development sponsors to evaluate the abuse potential of brain-penetrant compounds. It covers legal and regulatory frameworks, scheduling considerations, and key factors for conducting abuse liability studies. Authored by Beatriz Rocha, MD, PhD, it aims to assist sponsors in navigating the complexities of drug approval processes, ensuring compliance with FDA and DEA requirements, and enhancing patient access to safe and effective therapies.