The latest opioid approved by the FDA, Arymo ER, can only be “expected” to reduce abuse by one route – injection – in its official labeling. In a press release, drugmaker Egalet said the extended-release morphine formulation has “increased resistance to cutting, crushing, grinding or breaking using a variety of tools. Due to its physical and chemical properties, Arymo ER is expected to make abuse by injection difficult.” At an FDA advisory committee meeting last year, members voted for an expansion of the abuse-deterrent expectations on the label but it did not get approved. In the face of a national opioid abuse problem, experts have raised concerns that abuse deterrent properties are not assessed in post-market studies to determine if they are as effective in the real world as they are in a lab.
Further coverage from MedPage Today here.