FDA approves Egalet Corp.'s opioid prescription painkiller

Egalet Corp. in Wayne announced Monday that the Food and Drug Administration approved its opioid prescription painkiller formulated to make it harder to tamper with to get a quick high.

The FDA granted the company's abuse-deterrent claim that Arymo ER, a long-acting morphine pill, deters abuse by people seeking to dissolve and inject it. However, the company was also seeking a label claim that the drug deters abuse by those trying to snort it - referred to as intra-nasal abuse - and to chew it. Those label claims were denied for now.

The company can seek the intra-nasal claim again after October 2018, when a rival drugmaker's product MorphaBond loses patent exclusivity on the nasal deterrence claim. The FDA did not detail why the oral claim was not met.

Details about the label were discussed by Egalet management on an 8:15 p.m. investor call Monday evening.

Egalet's shares shot up from $8 a share earlier Monday to a high of $10 and then fell back down to close at $8.38.

The company was seeking labeling to market Arymo ER as abuse-deterrent if taken orally, nasally, or intravenously.

The FDA's decision stopped short of two FDA advisory committees that voted in August that Egalet's pill - one of more than a dozen abuse-deterrent formulations being developed by companies for oxycodone, hydrocodone, and morphine - was effective against abuse by chewing, crushing, snorting, or injecting.

The FDA experts voted 18-1 to approve labeling that described the drug as abuse-deterrent if taken orally, nasally, or intravenously.

The full FDA agency approved Arymo ER to manage "pain severe enough to require daily, around the clock, long-term opioid treatment and for which alternative treatment options are inadequate."

The FDA said abuse-deterrence studies showed Arymo ER's formulation was "more difficult to manipulate for misuse and abuse." The agency said testing showed the tablets, compared with other morphine sulfate extended-release versions, "have increased resistance to cutting, crushing, grinding, or breaking using a variety of tools" and when subjected to liquid, Arymo ER tablets form a gel "that resists passage through a hypodermic needle."

Egalet said approval triggers $40 million in new funding from a previously announced senior secured debt financing.

Egalet said it planned to launch Arymo ER - the company's first product using a plastic-like injection molding technology, similar to what is used to manufacture bottle caps and car bumpers - in the current quarter before March 31.

"With the majority of ER opioids in easy to abuse forms, it is important that health-care professionals have additional treatment options," said Egalet president and CEO Robert Radie. "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."

In October, the FDA told Egalet there would be a delay in approving the product. "The agency is working on the product label," Radie said at the time. The FDA had delayed approvals of three other abuse-deterrent opioids, giving analysts confidence that Egalet's product would likely be approved.