Crush-Resistant Formulation of Opana ER® Approved by the FDA

February 13, 2012 -  In December 2011, the U.S. Food and Drug Administration (FDA) granted approval to Endo Pharmaceuticals for their new, crush-resistant formulation of the long-acting opioid analgesic, Opana ER (extended release oxymorphone).  Newark, DE, based Endo developed the new formulation in partnership with Gruenthal. The new formulation, which utilizes the proprietary INTAC™ technology owned by Grunenthal, 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 means 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 contains a potent, Schedule II opioid, oxymorphone, indicated for the relief of moderate to severe pain requiring continuous around-the-clock-relief for an extended period of time. It is not meant for use in treating acute pain. The new formulation does not change or remove the risks inherent to opioid analgesics such as abuse, overuse, respiratory depression and sedation. These tablets are meant to be swallowed whole and should not be crushed, chewed or broken as doing so can release a potentially fatal dose of oxymorphone.

There is currently a shortage of the new formulation of Opana ER which is expected to be resolved by the middle of this month.

For more information, please refer to the full prescribing information: http://www.endo.com/pdf/products/Opana%20ER%20PI%2020111212.pdf

 

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