Egalet Corp. said Wednesday that the Food and Drug Administration does not object to the company's distributing materials to doctors promoting the abuse-deterrent properties of its opioid painkiller formulated to make it harder to tamper with to get a quick high.
The FDA in January approved the company's abuse-deterrent claim that Arymo ER, an extended-release morphine pill, deters abuse by people seeking to dissolve and inject it.
But the agency did not grant a label claim that the drug deters abuse by those trying to snort it — referred to as intranasal abuse — or to chew it. Those claims were denied for now. A competitor drug maker's morphine product, MorphaBond, has market exclusivity until October 2018 on the nasal-deterrence claim. The FDA did not say why the oral claim was not met.
Egalet said it plans to launch Arymo ER — the company's first product using a plastic-like injection molding technology, similar to that used to manufacture bottle caps and car bumpers — by Friday, a company spokeswoman said.
Egalet said it recently asked "whether the FDA would likely take enforcement action against Egalet if Egalet disseminated materials to health-care practitioners regarding Arymo ER's intranasal abuse-deterrent properties and the studies demonstrating the effects of these properties."
The FDA responded in a letter Monday that it "does not object" to Egalet's plans to distribute materials "based on the intranasal abuse-deterrence data in its original" new drug application submission, if the communications are "directed only to health-care professionals, include appropriate disclosures, and are otherwise truthful and non-misleading," the company said.
Two FDA advisory committees voted last August that Egalet's tablet was effective against abuse by chewing, crushing, snorting, or injecting.
FDA staff said in briefing papers that abuse-deterrent technologies to date have not been successful against the most common form of abuse — swallowing multiple pills to achieve a feeling of euphoria. Making opioids harder to crush, snort, or inject may help, but "there is still risk of abuse," the FDA said. As long as pills can deliver the opioid, "the risk for addiction will remain."
Egalet is one of more than a dozen companies working on abuse-deterrent formulations of oxycodone, hydrocodone, and morphine. Opioid abuse and overprescribing of opioids by physicians has come under intense scrutiny because addiction and overdose deaths have reached epidemic levels.
After the full FDA on Jan. 9 granted deterrent labeling only for injection, Egalet's stock dropped from $8.38 a share on Jan. 9 to $6.52 on Jan. 10, about 22 percent. Since then, investors have filed two class-action lawsuits in federal court in Philadelphia accusing Egalet of making false and misleading statements about the chances of the drug's receiving oral-abuse deterrent labeling. Investors purchased the stock between Dec. 15, 2015, and Jan. 9.