Abuse Liability Potential Working Group Dinner Session
Chairs: Marta Sokolowska, PhD; Michael Klein, PhD; Beatrice Setnik, PhD
The Abuse Deterrent Formulation Science Meeting: Review of the Recommendations and the Next Steps
Background:
In January 2013 FDA issued a Draft Guidance for Industry Abuse-Deterrent Opioids — Evaluation and Labeling. This document laid out FDA’s thinking regarding the types of data required to demonstrate abuse deterrent formulation (ADF) characteristics and the labeling claims that might be granted based on these data. As the FDA has acknowledged abuse deterrent formulations represent a new scientific field and there is much to be learned with regards to the formulations themselves and assessing their effectiveness in reducing opioid drug abuse.
Since the FDA expressed interest in collecting input on this Draft Guidance from academia, industry and governmental experts, an ADF Science Meeting was held in the fall of 2013. The objectives of this meeting were: 1) to provide an open forum enabling discussion and recommendations on the FDA Draft Guidance and 2) to provide an opportunity for presentations by experts addressing the Draft Guidance.
Objectives:
· To overview the FDA Draft Guidance on Abuse Deterrent Opioids – Evaluation and Labeling with the focus on clinical assessment of the ADF approaches
· To summarize the ADF Science Meeting discussions and recommendations
· To review directions for future developments of this field.