Using a proprietary technology, the manufacturer developed abuse deterrence that involves a physical and chemical barrier approach without using an opioid antagonist. The tablets are, therefore, difficult to manipulate for purposes of misuse and abuse. In vitro testing compared this treatment with non-abuse-deterrent morphine sulfate extended-release tablets. Armyo ER had an increased resistance to cutting, crushing, grinding or breaking when various tools were used. Additionally, due to its physical and chemical properties, it is expected that injection abuse will be difficult.
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However, the FDA advisory panel that reviewed the drug recommended the agent be labeled as an abuse-deterrent product via the oral, nasal and intravenous routes. The FDA typically follows these recommendations.3 This FDA approval will allow the company to claim only that the treatment deters abuse by those seeking to dissolve and inject it. It did not approve claims that the product deters abuse by the oral or nasal routes.
Three dosage strengths have been approved: 15 mg, 30 mg and 60 mg. And the product is expected to be available in the first quarter of 2017.
Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
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- Egalet Corp. News release: Egalet receives FDA approval for ARYMO ER (morphine sulfate) C-II, an extended-release morphine product formulated with abuse-deterrent properties for treatment of chronic pain. 2017 Jan 9.
- Clarke T. Egalet painkiller wins FDA approval but label disappoints. Reuters. 2017 Jan 9.