FDA Tweaks Label of Wayne’s Egalet Ahead of This Week’s Launch

By

Egalet CEO Robert Radie

A last-minute label change ordered by the Food and Drug Administration did little to tarnish the shining armor of the nation’s second drug-abuse-deterring, morphine-based medication.

Wayne-based Egalet Corp. is expected to launch its long-term daily pain management tablet, Arymo ER, this week, according to a Philadelphia Business Journal report by John George.

It’s Egalet’s first product made with the company’s Guardian anti-abuse technology, which makes the drug difficult to crush or inject.

Image via Egalet.

The FDA label decision barred Egalet from claiming Arymo ER deters abusers from snorting or chewing it, due to another product’s exclusivity rights.

“We didn’t think there was a high likelihood (the label would be restricted by exclusivity issues) based on what the FDA has been talking about with opioid abuse and encouraging innovation, so we were caught off guard (by the labeling decision),” said CEO Robert Radie.

The anti-injection claim, however, is the more valuable one.

“Morphine is most commonly abused intravenously,” he said. “That’s also the most dangerous route. People have the highest likelihood of overdosing when they are taking it intravenously.”

Read more about the label issue and the Arymo ER launch in the Philadelphia Business Journal here, and check out previous VISTA Today coverage of Egalet here.


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