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Egalet wins partial label change for abuse-deterrent med

March 30, 2017

Amid a raging opioid epidemic, Egalet Corp EGLT soared as high as 13 percent Wednesday after the U.S. Food and Drug Administration permitted it to distribute promotional material highlighting the abuse-deterrent properties of intranasal ARYMO ER.

The detail is small but notable for Egalet.

In January, its shares had peaked on ARYMO’s FDA approval but waned on news that the official “abuse-deterrent” tag could only be applied to intravenous — not oral or intranasal — labels.

“In our recent approval, we did in fact get language in the label that supports that ARYMO is likely to discourage abuse via the intravenous route,” CEO Robert Radie told Benzinga at the time. “We are listed on the FDA website as the eighth approved abuse-deterrent, extended-release opioid that they’ve approved over the last number of years.”

The FDA had withheld the intranasal label only to honor exclusivity awarded to Inspirion Delivery Technologies’ Morphabond through 2018.

Egalet challenged the Morphabond claim, particularly as the competitor had yet to be brought to market two years after securing regulatory approval. The FDA is still considering the appeal.

http://bit.ly/2nCEynJ

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