Egalet painkiller wins FDAapproval but label disappoints Egalet plans to launch Arymo ER, approved in three dosage strengths: 15 mg, 30 mg and 60 mg, in the US in the first quarter of 2017 THE US Food and Drug Administration has approved Egalet Corp's long-acting opioid painkiller, Arymo ER, and will allow the company to claim it deters abuse by those seeking to dissolve and inject it. However, investors had hoped the company would also be allowed to claim the drug deters abuse by those seeking to snort or chew it. The FDA’s decision ran counter to a recommendation by its advisory panel, which in August voted 18-1 in favour of approval. The panel recommended the drug be labelled as an abuse-deterrent product via all three routes: oral, nasal and intravenous. The FDA typically follows the advice of its advisory panels but is not obliged to do so. Arymo ER is a long-acting variation of morphine that is intended to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment. The FDA said in a statement that an extended-release morphine product made by Daiichi Sankyo, MorphaBond, has market exclusivity on the ability to claim it deters snorting. The company is exclusively allowed to make that claim until October 2, 2018. The FDA did not say whether it will allow Egalet to make the snorting-deterrence claim when Daiichi's exclusivity runs out, but it will be able to do so if it wishes. The FDA did not approve a claim that the drug deters abuse via the oral route. The abuse of opioids, a class of drugs that includes heroin and prescription pain-killers, has reached epidemic proportions in the US. The Centers for Disease Control and Prevention estimates that 78 Americans die every day from an opioid overdose. Egalet plans to launch Arymo ER, approved in three dosage strengths: 15 mg, 30 mg and 60 mg, in the US in the first quarter of 2017. The same advisory panel
that recommended Egalet's drug also recommended the FDA approve a long-acting opi-
oid made by Teva Pharmaceutical Industries, Vantrela ER. It also recommended approval of
a long-acting, abuse-deterrent opioid made by Pfizer, Troxyca ER, although it had reserva-
tions about the drug's ability to curb all forms of abuse. Reuters
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