Arymo ER (morphine sulfate) approved by FDA for pain- Egalet Corporation
Egalet Corporation has announced that the FDA has approved Arymo ER (morphine sulfate) extended-release (ER) tablets C-II 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.
Results from in vitro testing demonstrated that Arymo ER tablets, in comparison to non-abuse-deterrent morphine sulfate extended-release tablets, have 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.
Comment: Arymo ER is the first approved product developed using Egalet's proprietary Guardian Technology�a physical and chemical barrier approach to abuse deterrence without the use of an opioid antagonist�creating tablets that are difficult to manipulate for the purpose of misuse and abuse.
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