Abuse-Potential Solution
WCG's Abuse-Potential Solution is the only standardized system to systematically assess abuse-related events in clinical trials, supporting approval, labeling and scheduling decisions.
WCG's Abuse-Potential Solution is the only standardized system to systematically assess abuse-related events in clinical trials, supporting approval, labeling and scheduling decisions.
WCG’s Misuse, Abuse, and Diversion Drug Event Reporting System (MADDERS®) provides robust identification and assessment of potential abuse-related events as they occur in clinical trials. This allows sponsors and the FDA to more accurately evaluate a drug’s abuse potential in the very patients the medication is designed to treat.
MADDERS provides contextual information on whether triggering events are attributable to non-medical use of study medication or are merely false positives.
Initially developed in collaboration with the public-private FDA-ACTTION initiative (LEARN MORE), MADDERS fills a need for standardized approaches to quantifying potential abuse in clinical trials, and should be used for any trial medication that crosses the blood-brain barrier.
“To our knowledge, MADDERS is the only system available to comprehensively evaluate inappropriate medication use events prospectively to determine the underlying intent.”
– Smith SN et al., J Pain, 2017
Conventional retrospective approaches often lead to overestimation or underestimation of abuse potential. MADDERS dives deeper and focuses on those for whom the drug was designed. Only MADDERS identifies inappropriate-use events and, using subject-matter experts, categorizes them based on underlying intent.
Without this data and the accompanying report, sponsors potentially place their drug approval at risk. A drug without abuse potential may end up being scheduled–or scheduled higher than necessary, limiting patient access and undermining the sponsor’s ROI. The reverse presents an even greater danger: Drugs with abuse potential are improperly scheduled, leading to potential patient harm and sponsor liability.
By collecting and assessing the right information about potential abuse you are minimizing unnecessary risk. MADDERS helps to mitigate that risk.
Support informed scheduling and labeling
Gather contextual information about events of interest to the FDA to better document abuse potential and support appropriate scheduling and labeling.
Stay ahead of regulatory requirements
Be prepared. MADDERS is based on FDA guidance for assessment of abuse potential in CNS trials. Guidance often becomes a requirement.
Integrate seamlessly
Add MADDERS to ongoing trials with minimal effort. Easy setup, low-impact integration and no IRB approval.
Complete the form to request a schedule a consultation. We’ll demo MADDERS, assess your needs and show you how WCG Analgesic Solutions can help.