FDA Rebukes Egalet's Reliance On OxyContin Postmarketing Data

08 Aug 2016

Arymo ER sponsor's consultants said Purdue's postmarketing data on its reformulated oxycodone establish a link between abuse-deterrent properties and reduced real-world abuse, but FDA says it disagreed with the conclusion in the context of an OxyContin labeling supplement.

A sponsor that seeks to piggyback on a potential competitor's study results may want to first ensure that FDA agrees the data prove the point the company is trying to make.

Such was the case at the Aug. 4 advisory committee review of Egalet Corp.'s long-acting opioid Arymo ER (morphine...