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Egalet's opioid receives tentative FDA approval for abuse-deterrent label


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Egalet's opioid receives tentative FDA approval for abuse-deterrent label

The U.S. Food and Drug Administration granted tentative approval to update the label of Egalet Corp.'s opioid Arymo extended-release tablet with an intranasal abuse-deterrent claim.

Arymo, or morphine sulfate, extended-release tablet was approved in January for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

The updated label will also include data from a study demonstrating that inhaling a manipulated tablet led to significantly less drug liking compared with crushed non-abuse-deterrent morphine sulfate extended-release tablets.

While the earlier FDA approval acknowledged that Arymo's abuse was difficult by injection, it said abuse by the intravenous, intranasal and oral routes was still possible.

The additional claim was previously excluded from the label at approval due to exclusivity granted to Daiichi Sankyo Co. Ltd. and Inspirion Delivery Sciences LLC's MorphaBond tablet regarding intranasal abuse deterrence.

The final approval is expected to be granted when MorphaBond's exclusivity period expires on Oct. 2, 2018.