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FDA Issues Draft Guidance on Abuse-Deterrent Formulations of Generic Opioids

Supporting the Development of Abuse-Deterrent Generic Opioids

On March 24, 2016, the FDA issued a draft guidance titled “General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products.” This guidance recommends studies a generic applicant should conduct so FDA can evaluate the abuse deterrence of certain generic opioid drug products and help ensure that generic versions of approved opioids with abuse-deterrent formulations (ADFs) are no less abuse-deterrent than the brand named drug. Providing this guidance is an important step in supporting the development of and access to abuse-deterrent opioids.

Part of the FDA’s overarching Opioid Action Plan, abuse-deterrent technology is a critical approach that the agency is very interested in stimulating. The FDA recognizes that ADF opioids are not failsafe, but the potential of such products to deter abuse, both by patients and non-patients, is real, and the agency fully supports efforts to advance this technology.

“Abuse-deterrent properties” are defined as those properties shown to meaningfully deter abuse, even if they do not fully prevent abuse. Because opioid drug products must in the end be able to deliver the opioid to the patient, there may always be some potential for abuse of these products.

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