On April 1, 2015, the FDA issued a final guidance to assist industry in developing opioid drug products with potentially abuse-deterrent properties. "Guidance for Industry: Abuse-Deterrent Opioids—Evaluation and Labeling" explains the FDA's current thinking about the studies that should be conducted to demonstrate that a given formulation has abuse-deterrent properties, makes recommendations about how those studies should be performed and evaluated, and discusses what labeling claims may be approved based on the results of those studies.
INTAC® technology falls into Abuse-Deterrent Formulation (ADF) Category:
physical/chemical barriers. Products using INTAC® have been tested in premarketing studies:
*According to categorization in FDA final “Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling”.
Postmarketing Studies after introduction of ADF products: