The FDA has approved a new formulation of Endo‘s Opana ER (oxymorphone HCl) extended-release tablets designed to be crush-resistant. The redesigned formulation utilizes Grunenthal’s proprietary INTAC technology. The crush-resistant formulation will continue to be called Opana ER with the same dosage strengths, color and packaging and similar tablet size and shape. Also, the FDA approval signifies that there is no significant difference in the rate and extent of absorption of the therapeutic ingredient between this new formulation and the original formulation of Opana ER.

Opana ER, a CII controlled substance, is indicated for the relief of moderate-to-severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time.

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