Egalet gains FDA approval for difficult to abuse painkiller

pharmafile | January 10, 2017 | News story | Manufacturing and Production, Research and Development, Sales and Marketing Arymo ER, Egalet Corp, FDA 

Egalet has gained FDA approval for Arymo ER, a long-acting opioid painkiller that is made to be difficult to breakdown. The pill is a form of morphine used for those suffering pain in their everyday life but has been designed to be very difficult to abuse. With the opioid crisis hitting the headlines with ever-greater frequency in the US, a tool to combat these issues is welcome news.

The pill is designed to be extremely hard and therefore difficult to break up and crush. The most common method of opioid abuse is to crush opioids and then deliver the drug through intravenous injection. Those looking to abuse opioids tend to crush the tablets to allow the drug to be metabolised by the body as quickly as possible. The FDA has granted approval for Egalet to advertise the drug as difficult to dissolve and inject, making it more likely to be prescribed by doctors worried about the potential for abuse.

The decision by the FDA comes after the recommendation of its advisory panel that the drug should be approved, in an 18-1 vote in favour of approval, and for it to be labelled as an abuse-deterrent product via the three routes, oral, nasal and intravenous. It comes as something of a blow that the FDA only allowed Egalet to advertise as deterrent to injection.

“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,” said Bob Radie, president and chief executive officer of Egalet. “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. With our commercial organization in place, we are ready to launch Arymo ER in the first quarter of 2017.”

With the opioid abuse crisis showing no signs of abating, this kind of approval, with drugs being made to difficult to abuse, is likely to increase. The advisory panel that recommended Arymo ER also took the action to approve Teva’s extended-release tablets that are also designed to deter abuse.

Ben Hargreaves

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