SILVER SPRING, Md. — The Food and Drug Administration has approved Arymo ER (morphine sulfate), an extended-release morphine tablet with abuse-deterrent properties, the company announced Monday.
The drug is indicated to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative options are inadequate. Egalet said Arymo ER is the first drug approved using its proprietary Guardian Technology, which works to deter abuse and prevent the tablets from being manipulated for abuse or misuse.
With the majority of ER opioids in easy to abuse forms, it is important that healthcare professionals have additional treatment options like Arymo ER that are resistant to different methods of manipulation using a variety of tools,” Egalet president and CEO Bob Radie, said. “Arymo ER has physical and chemical properties expected to make abuse by injection difficult, which is important given it is the most common non-oral route of morphine abuse and the most dangerous.”
Arymo ER was approved in 15-, 30- and 60-mg dosage strengths and the company expects a launch in the first quarter of 2017.