FDA Panel Nod For Egalet Opioid's Deterrence Claims Made Easier By Tablet Hardness

05 Aug 2016

Inability to chew Arymo ER tablet helps Egalet overcome questions about clinical meaningfulness of human oral abuse study results; advisors also back intranasal, intravenous deterrence claims.

The inability to chew Egalet Corp.'s Arymo ER (morphine sulfate extended-release) was enough to earn an FDA advisory committee's endorsement for an oral abuse-deterrence claim despite lingering uncertainty as to the clinical relevance of results from a human oral abuse study.

In a series of votes during an Aug. 4 meeting, the Anesthetic and Analgesic Drug Products and Drug Safety and...