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Drug Safety and Risk Management Advisory Committee (DSRM) and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC)

The Committees discussed safety issues for new drug application (NDA) 201655, OPANA ER (oxymorphone hydrochloride) Extended-release Tablets, by Endo Pharmaceuticals Inc., with the indication of management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The product is an approved extended-release (ER) formulation intended to have abuse-deterrent properties based on its physicochemical properties, however, this information is not currently reflected in product labeling.

A majority of the Committee, 18 of 27 members, voted that the benefits of reformulated OPANA ER do not continue to outweigh its risks.