FDA Approves Extended-Release Morphine Product Formulated With Abuse-Deterrent Properties


Get Permission

On January 9, the U.S. Food and Drug Administration (FDA) ap­proved morphine sulfate extended-­release tablets with abuse-deterrent properties (Arymo ER), a C-II drug 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.

The new formulation of extended-release morphine sulfate is the first approved product developed using Egalet’s 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 this formulation, in comparison to non–abuse-deterrent morphine sulfate extended-release tablets, have increased resistance to cutting, crushing, grinding, or breaking the tablets using a variety of tools. Due to its physical and chemical properties, the new product is expected to 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 is important that we have more abuse-deterrent treatment options … if and when these pain treatments end up in the wrong hands,” said Nathaniel Katz, MD, a neurologist and pain specialist as well as founder and President of Analgesic Solutions.

The new morphine sulfate extended-release tablets have been approved in three dosage strengths: 15 mg, 30 mg, and 60 mg.

“With the majority of [extended-release] opioids in easy-to-abuse forms, it is important that health-care professionals have additional treatment options…that are resistant to different methods of manipulation using a variety of tools,” said Bob Radie, President and Chief Executive Officer of Egalet. ■



Advertisement

Advertisement



Advertisement