No Abuse-Resistance Claim For Endo’s Opana ER Reformulation
This article was originally published in The Pink Sheet Daily
Endo’s Opana ER reformulation, which uses proprietary technology to deter crushing, receives approval but no labeling language on crush-resistance or abuse deterrence, according to FDA. The company says a U.S. patent to be issued Dec. 13 will protect the new formulation until November 2023.
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FDA advisory committees will weigh concerns that Endo’s reformulated version of oxymorphone extended-release, which does not contain abuse-deterrent labeling, has shifted preferred non-oral route of abuse from intranasal to intravenous, which carries additional safety risks.
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Endo continues to believe it can rebuild Opana ER, despite generic competition, by adding abuse-deterrent labeling and securing critical intellectual property protection.