This month's negative FDA panel review of Zohydro ER from Zogenix Inc. turned into a referendum on the classwide REMS for extended-release and long-acting opioids the agency promulgated in July. Whether or not FDA approves the compound anyway will say a lot about how the agency plans to treat drugs in this class going forward.

The panel's votes present FDA with two dilemmas, one general to the drug class and one specific to Zohydro ER.