Egalet’s ‘Abuse-Deterrent’ Pain Killer Wins FDA Approval

The United States Food and Drug Administration (FDA) announced this week that they approved of an extended release pain killer called ARYMO ER by the pharmaceutical company Egalet.

It’s no secret that opioid abuse is a growing problem in the United States. Last month’s “Morbidity and Mortality Weekly Report” revealed a 300% increase in the number of drug overdose deaths from 1999 to 2014. In fact, the Centers for Disease Control and Prevention explained that the number of people who died from a drug overdose in New York increased by over 100%, with the largest number of opioid related drug overdoses taking place in New York, Connecticut and Illinois.

According to a press release, ARYMO ER was the first pharmaceutical product created by Egalet’s proprietary formula, which allows for a new way to treat pain. The company boasts in their announcement that unlike many other painkillers ARYMO ER is difficult for people to misuse and abuse making it an abuse-deterrent.

Essentially, Egalet designed a product that would make it difficult for people to chew, snort or otherwise misuse the painkiller. In effect, the pharmaceutical company was hoping that their proprietary Guardian Technology would allow for the FDA to grant the drug an abuse-deterrent label from the FDA. However, the FDA only allowed the abuse-deterrent label to be apply to dissolving or injecting the drug and not, snorting or chewing.

In a statement, Egalet’s president and CEO, Bob Radie, explained, “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 will come in three different dosages: 15 mg, 30 mg and 60 mg. The commercial launch is planned for early 2017.