Advisory Committees Support Egalet’s Opioid Arymo With Abuse-Deterrent Labels

Two FDA advisory committees recommend the approval of Egalet’s opioid Arymo to manage severe pain that requires daily, long-term treatment when alternatives are unavailable, with three abuse-deterrent labels.

The committee members voted 18-1 for the approval of the extended-release tablets, with none of the panelists calling into question the efficacy of the candidate. The panel’s discussion instead centered on the evidence presented on oral abuse of the candidate.

In an oral-abuse deterrence study, Arymo showed minor, yet statistically significant differences compared to its reference product, Purdue Pharma LP’s MS Contin. The candidate, however, missed the secondary endpoints of the trial, which related to patient’s propensity to take the drug again.