ALERRT® Provides Important Data to Support Category 1 Evaluations of Abuse-Deterrent Drug Formulations
The ALERRT Instrument enables you to quantify the “work” (or degree of effort) required to tamper with pharmaceuticals, and is a key way that sponsors can demonstrate to the FDA how robust their abuse-deterrent formulations are when subjected to physical manipulations likely to occur in the real world. The 2015 FDA Guidance indicates that “degree of effort” of tampering should be assessed in Category 1 studies of abuse-deterrent opioids.
Use the ALERRT Instrument in studies to:
- Collect data on degree of effort associated with tampering of a product as called for in FDA guidance
- Quantify how easily abuse-deterrent formulations can be defeated by real-world physical manipulations
- Compare “work” requirements of pharmaceutical drug products (e.g., innovator and comparators) using common household tools
- Aid in formulation selection in early development efforts
Work = time + individual effort + resources
PinneyAssociates scientists are leaders in the Category 1 assessment of abuse-deterrent drugs and formulations. Through our regular engagement with FDA, we have unique insights into the regulatory expectations of abuse-deterrent evaluations.
Cone EJ, Sokolowska M, Lindhardt K. (2016) Striving for consensus on approaches to Category 1 testing of abuse-deterrent formulations of opioids: Discussions from the first Category 1 focus group meeting. Pain Practice.
Cone EJ, Buchhalter AR, Lindhart K, Elhauge T, Dayno JM. (2017) The ALERRT® instrument: A quantitative measure of the effort required to compromise prescription opioid abuse-deterrent tablets. American Journal of Drug and Alcohol Abuse.
FDA. 2015. Guidance for Industry. Abuse-Deterrent Opioids – Evaluation and Labeling.