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.

 

Download the draft guidance here

 

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”.

 

Premarketing Studies:

 

Postmarketing Studies after introduction of ADF products:

 

 

INTAC®