FDA Approves Arymo ER (morphine sulfate), New Abuse-Deterrent Opioid
The US Food and Drug Administration (FDA) announced the approval of Arymo ER (morphine sulfate) 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,” noted a press release from the manufacturer Egalet Pharma.
Arymo ER is manufactured with Egalet’s proprietary Guardian Technology—a physical and chemical barrier approach to abuse deterrence without the use of an opioid antagonist. The technology uses a polymer matrix that “results in tablets that are hard and difficult to manipulate for misuse and abuse. This approach offers the ability to design tablets with controlled-release profiles as well as physical and chemical properties that have been demonstrated to resist both common and rigorous methods of manipulation,” noted the company.
The FDA Advisory board voted to approve Arymo in August, 2016.
Tablets manufactured with this technology have been shown to have increased resistance to physical methods of manipulation, such as cutting, crushing, grinding or breaking using a variety of mechanical and electrical tools. They are also resistant to chemical manipulation and attempts at extraction and turn into a viscous hydrogel on contact with liquid, making syringeability very 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, like Arymo ER, if and when these pain treatments end up in the wrong hands," said Nathaniel Katz, MD, neurologist and pain specialist as well as founder and president of Analgesic Solutions.
Arymo ER will be available in 3 dosage strengths: 15 mg, 30 mg, and 60 mg. The commercial launch is planned for the first quarter 2017.