Panel to consider postmarket abuse-deterrent studies

FDA posted briefing documents ahead of this week's joint meeting of the Anesthetic and Life Support Drugs and Drug Safety and Risk Management advisory committees to discuss postmarketing studies intended to support abuse deterrence claims of opioid drugs formulated specifically to deter abuse. FDA said the discussions, which are scheduled for Thursday and Friday, are intended to define a "gold-standard" study or studies for evaluating the actual abuse of products designed to be abuse deterrent. An FDA reviewer added that only postmarketing epidemiological studies can provide final evidence of a drug's ability to deter abuse.

The panel will discuss proposed study designs for controlled-release OxyContin oxycodone and Embeda morphine/naltrexone, but will not be asked to evaluate their quality or adequacy because FDA has yet to provide feedback to the drugs' respective manufacturers, Purdue Pharma L.P. (Stamford, Conn.) and King Pharmaceuticals Inc. (NYSE:KG). FDA also will ask the panel to consider the databases that would be most useful for measuring abuse and misuse; if new databases need to be created; the appropriate active comparators for postmarket studies; if it is possible to determine a minimum reduction in abuse and misuse to support a claim of abuse deterrence; and the aspects of the proposed studies that would be useful in determining general abuse-deterrent effects. ...