Long-acting opioid painkiller wins approval

January 17, 2017

FDA recently approved a long-acting opioid designed to deter abuse.

FDA approved a long-acting opioid designed to deter abuse.

Morphine sulfate extended-release (ER) tablets C-II (Arymo ER, Egalet) has been approved 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.

Related: FDA requires warning on opioids

The US commercial launch of Arymo ER is planned for the first quarter of 2017. The drug is approved in 3 dosage strengths: 15 mg, 30 mg and 60 mg.

Arymo ER uses 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.

“Due to its physical and chemical properties, Arymo ER is expected to make abuse by injection difficult,” Egalet said in a statement.

Related: Top 4 ways US is combating opioid epidemic

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.

"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 and president of Analgesic Solutions.

Read more: CDC issues opioid prescribing guidelines

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