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Development of Central Nervous System Drugs with Abuse Potential

Track:
Project/Portfolio Management and Strategic Planning

Day & Time:
June 17, 3:30PM - 5:00PM (Pacific Standard Time)

Session Number:
283

Room Number:
1A

Level:
Advanced

Type:
Session

Title:
Development of Central Nervous System Drugs with Abuse Potential

Chair(s):
Anne Tomalin, RAC
President
Therapeutic Products Inc, Canada

Description:
This session will explore the FDA/Drug Enforcement Administration's process for defining and managing controlled drugs, the conduct of clinical trials of drugs with abuse potential, and current state of the art regarding abuse-resistant formulations and associated labeling claims. The development of products with abuse potential is a quickly evolving area within our industry, and rules governing what can and cannot be done are quickly changing. This session will provide newcomers with an overview of the current status of such development and will provide those who have been involved in the area for some time with a recent update.

Learning Objective(s):
Explain what a controlled substance is including the process for drug scheduling; Describe how abuse liability is assessed during drug development; Apply knowledge of drug scheduling and FDA requirements for proactive management of a drug development project; Discuss the conduct of clinical trials for drugs with abuse potential; Describe current state of the art of abuse resistant/deterrant formulations; Explain the regulatory requirements for label claims of such formulations.

Presentation(s) & Speaker(s):
Assessment of Abuse Liability in Drug Development for Central Nervous System Active Compounds
Eva Finney, PhD, PMP
Director, Global Project Management
Merck & Co., Inc., United States

Development of Abuse Resistant/Deterrant Formulations and Associated Label Claims
Damon Smith
Chief Executive Officer
Altus Formulation Inc., Canada

Conducting Clinical Trials with Drugs Having Abuse Potential
Ann Marie Hake, MD
Medical Advisor, Medical Division, Neurosciences
Lilly USA, LLC, United States