The US Food and Drug Administration (FDA) has approved an extended-release (ER) morphine sulfate C-II (Arymo ER, Egalet Corp) for the management of pain severe enough to require round-the-clock, long-term opioid management for which alternative treatments are inadequate, the company has announced.
The product is the first approved to use Egalet's proprietary Guardian technology, a physical and chemical barrier approach to abuse deterrence without the use of an opioid antagonist. The technology allows the creation of tablets that are difficult to manipulate for the purpose of misuse and abuse, the company says.
The labeling for the drug reportedly will cover abuse via intravenous and oral methods but not intranasally.
In August 2016, at a joint meeting of two FDA panels, the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee, panelists voted overwhelmingly in favor of approving Arymo ER — and recommended the drug be labeled as an abuse deterrent product via oral, nasal, and intravenous routes for pain.
The drug has been approved in three dosage strengths: 15 mg, 30 mg, and 60 mg. The US commercial launch is planned for the first quarter of this year.
Results from in vitro testing demonstrated that the new tablets, compared with non–abuse-deterrent morphine sulfate ER tablets, have increased resistance to cutting, crushing, grinding, or breaking using a variety of tools, the company said.
Because of its physical and chemical properties, the product is expected to also make abuse by injection difficult.
"Given the need for treatments for the millions of Americans living with chronic pain, the growing problem of prescription abuse and the fact that we know diversion is a huge problem, it's important that we have more abuse-deterrent treatment options, like Arymo ER, if and when these pain treatments end up in the wrong hands," said Nathaniel Katz, MD, neurologist and pain specialist and founder and president of Analgesic Solutions, in the Egalet press release.
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Cite this: FDA Okays Morphine Sulfate (Arymo ER) for Chronic Pain - Medscape - Jan 10, 2017.