FDA guidance sidesteps existing opioids

FDA issued Zohydro ER from Zogenix Inc. (NASDSAQ:ZGNX), is still up in the air. Zohydro is under review with a March 1 PDUFA date. In December, an FDA advisory committee recommended against approval of the opioid, which lacks abuse-deterrent technologies, because of concerns about abuse potential (see BioCentury, Dec. 17, 2012).

In the guidance, FDA says it will take a "flexible, adaptive approach" to evaluate potentially abuse-deterrent opioids and outlines six categories of abuse-deterrent formulations, including physical or chemical barriers, agonist/antagonist combinations and aversion methods that combine the opioid with substances that produce unpleasant effects at higher doses. The guidance also specifies four potential "tiers" of claims that could be included in the label for an abuse-deterrent opioid that depend on available data. According to FDA, there are no approved opioids with an abuse-deterrent labeling claim. ...