Analgesic Solutions Presenting MADDERS® System at the Advancements and Challenges in Abuse Potential Evaluation Meeting
Published: Oct 10, 2018
WAYLAND, Mass., Oct. 10, 2018 /PRNewswire/ -- Dr. Ryan Lanier, Ph.D., Associate Director, Consulting Unit at Analgesic Solutions will present "A Systematic Approach to Monitor Misuse, Abuse and Diversion in Clinical Trials (MADDERS)" at the Advancements and Challenges in Abuse Potential Evaluation Meeting on Thursday October 11th in Bethesda, MD. This meeting is organized by the Cross-Company Abuse Liability Council (CCALC) supported by scientific advice from Food and Drug Administration (FDA) and includes representation from industry, FDA and the National Institute on Drug Abuse (NIDA). The purpose of CCALC is to formulate and communicate scientific perspectives about medication abuse and its mitigation.
Dr. Lanier will also participate in a Panel Discussion focused on gaining consensus on adverse events (AEs) of interest, best practices for collection of AEs in clinical trials, and best practices for data presentation, topics which are vital to those in regulatory and industry positions involved with the assessment of abuse potential of new medications. Dr. Lanier stated, "The MADDERS system was developed as a direct result of recommendations made by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION), a public-private partnership with the FDA to more accurately and reliably assess abuse potential in clinical trials. We are excited to present what we believe to be the current state of the art when it comes to a system for monitoring misuse, abuse and diversion in clinical trials."
ABOUT MADDERS® System
As of 2017, all investigational drug products with possible Central Nervous System (CNS) activity are required by the FDA to be comprehensively assessed for abuse potential1. MADDERS system provides a robust assessment of a medication's abuse potential to support appropriate approval, labeling, and scheduling decisions. MADDERS system is the only standardized system which prospectively and systematically assesses potentially abuse-related events in clinical trials.
ABOUT ANALGESIC SOLUTIONS
Analgesic Solutions, LLC., founded in 2006, is a privately held company that increases the separation between placebo and active treatment in clinical trials through consulting, innovative tools, central statistical monitoring, technology and specialized training. With hundreds of projects completed and ongoing collaborations with regulatory authorities, Analgesic Solutions is the premier choice for mitigating risk associated with measurement error in clinical trials, and the correct scheduling of abuse potential drugs.
1 Food and Drug Administration Center for Drug Evaluation and Research (2017). Guidance for Industry: Assessment of Abuse Potential of Drugs (FDA Maryland).
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SOURCE Analgesic Solutions