Posted by Michael Wonder on 10 Jan 2017
Egalet receives FDA approval for Arymo ER (morphine sulphate) C-II, an extended release morphine product formulated with abuse deterrent properties for treatment of chronic pain
9 January 2017 - Egalet Corporation today announced that the U.S. FDA has approved Arymo ER (morphine sulphate) 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.
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. Results from in vitro testing demonstrated that Arymo ER tablets, in comparison to non-abuse-deterrent morphine sulphate 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.
