Egalet painkiller wins FDA approval but label disappoints

[January 10, 2017]  By Toni Clarke

(Reuters) - The U.S. Food and Drug Administration on Monday 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. That did not happen, and the company's shares fell 5 percent to $8.00 after the market closed.

Details about the label were revealed only after the announcement of the approval, which initially sent the shares up 27 percent.

The FDA's decision ran counter to a recommendation by its advisory panel, which in August voted 18-1 in favor of approval. The panel recommended the drug be labeled 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 Oct. 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 United States. 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 United States in the first quarter of 2017.

The same advisory panel that recommended Egalet's drug also recommended the FDA approve a long-acting opioid made by Teva Pharmaceutical Industries Ltd, Vantrela ER.

It also recommended approval of a long-acting, abuse-deterrent opioid made by Pfizer Inc, Troxyca ER, although it had reservations about the drug's ability to curb all forms of abuse.

(Reporting by Toni Clarke in Washington and Dipika Jain in Bengaluru; Editing by Shounak Dasgupta and Dan Grebler)

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