The FDA has approved Arymo ER (extended-release morphine sulfate tablets C-II, Egalet Corporation) for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Arymo ER has been approved in three dosage strengths: 15 mg, 30 mg, and 60 mg. The U.S. commercial launch is planned for the first quarter of 2017.
Arymo ER uses Egalet’s proprietary Guardian technology—a physical and chemical barrier approach to abuse deterrence without the use of an opioid antagonist. The technology creates tablets that are difficult to manipulate for the purpose of misuse or abuse. Results from in vitro testing have shown that Arymo ER tablets, in comparison with non–abuse-deterrent morphine sulfate extended-release tablets, have increased resistance to cutting, crushing, grinding, or breaking using a variety of tools. Because of its physical and chemical properties, Aymo ER is expected to make abuse by injection difficult.
Source: Egalet Corporation; January 9, 2016.