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March 24, 2016.
The U.S. Food and Drug Administration (FDA) today issued a draft guidance intended to support industry in their development of generic versions of approved opioids with abuse-deterrent formulations (ADF) while ensuring that generic ADF opioids are no less abuse-deterrent than the brand-name drug. In the guidance (General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products), FDA encourages industry efforts to develop pain medicines that are more difficult to abuse. Abuse-deterrent properties make certain types of abuse, such as crushing a tablet in order to snort the contents or dissolving a capsule in order to inject its contents, more difficult or less rewarding. The draft guidance includes recommendations about the studies that should be conducted to demonstrate that a generic opioid is no less abuse-deterrent than the brand name product, with respect to all potential routes of abuse. The FDA is encouraging feedback from all stakeholders during the 60-day comment period on this draft guidance.