Analgesic Solutions developed the Misuse, Abuse, and Diversion Drug Event Reporting System (MADDERS®) in response to an initiative by the ACTTION FDA public-private partnership to address the need for standardized approaches to quantifying potential abuse in clinical trials
Assessing Abuse Potential: Regulatory Requirements
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 liability. MADDERS provides a robust assessment of your medication’s abuse liability to support appropriate approval, labeling and scheduling decisions.
MADDERS, developed in response to the FDA-ACTTION initiative, is applicable to all CNS-acting drugs including such indications as pain, depression, anxiety, ADHD and epilepsy.
MADDERS utilizes trained investigators and an Adjudication Committee to:
- Actively identify potentially-abuse related events
- Complete event-related questionnaires
- Classify events according to consensus terminology
MADDERS 5-Step Process
Evidence Supporting MADDERS
The development and validation of MADDERS was presented in a recent paper published by the The American Journal of Addiction. MADDERS has been successfully implemented in over 14 clinical trials in various indications, including chronic pain and epilepsy.
“We are aware of no assessment other than MADDERS that gathers as much information about inappropriate medication use events in an attempt to discern the putative intent underlying the event. In fact, the value of the system lies in its focus on sufficiently documenting triggering events that occur in trials, rather than characteristics of the individuals in the trial.”
-ALERTT Working Group of ACTTION