FDA Encourages Development of Abuse-Deterrent (AD) Generic Opioids

In advance of FDA’s Public Meeting on Pre-Market Evaluation of Abuse-Deterrent Properties of Opioid Drug Products (October 31 – November 1, 2016), FDA Voice published Key Facts about Abuse-Deterrent Opioids, by Douglas C. Throckmorton, M.D. In his article, Throckmorton reminds us that “It’s important to recognize that FDA refers to these drugs as ‘abuse-deterrent’ not abuse-proof” and that “Still, abuse deterrent technology certainly helps. That’s why FDA is looking at ways to encourage the development of abuse-deterrent generic versions of an opioid since none currently exist.” Click here for the full story and be sure to scroll down.

The Public Meeting was held to “discuss scientific and technical issues relating to formulation development and pre-market evaluation of opioid drug products with abuse-deterrent properties” and for input into the approach to testing outlined in FDA’s Draft Guidance entitled General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products, issued March 2016.

The webcast is applicable to both NDA and ANDA development and compares current challenges to FDA’s vision for future AD development. Included are such considerations as quantitative measures/conditions of failure point. Additionally, quality attributes that may be tested on release and stability that correlate with maintenance of AD properties throughout drug product shelf lives are discussed. Click here for the webcast or here if you would like to talk to PDG about meeting with FDA.