The latest opioid approved by FDA will be “expected” to reduce abuse by only one route — injection — in its official labeling.
In a carefully-worded press release, drugmaker Egalet said its extended-release morphine drug Arymo ER “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.”
In an FDA advisory committee meeting last year, participants voted that the drug could deter abuse via the oral, nasal, and intravenous routes of abuse. But there were several reasons only the intravenous route won labeling.
An FDA spokesperson told MedPage Today that MorphaBond, another morphine product, has “marketing exclusivity for labeling describing the expected reduction of abuse of single-entity, extended-release morphine by the intranasal route due to physicochemical properties.” MORE HERE