Panel ponders post-market proof for opioids

A joint FDA advisory panel agreed that there is currently no gold-standard study or studies for evaluating the actual abuse of opioid products designed to be abuse deterrent. FDA had said the discussions of the Anesthetic and Life Support Drugs and Drug Safety and Risk Management advisory committees, which met Thursday and Friday, were intended to define such a standard. The panel members also agreed that a broad claim of "abuse-deterrent" is not currently possible, but a product-specific claim -- such as that a tablet is "injection-resistant" -- would be possible with post-marketing studies of a minimum duration of three years using existing surveillance databases. ...