FDA approves crush-resistant painkiller by Endo

New formulation of Opana ER designed to prevent tampering

CHADDS FORD, Pa. — The Food and Drug Administration has approved a new formulation of a painkiller made by Endo Pharmaceuticals designed to thwart drug abuse, Endo said Monday.

Endo announced the FDA's approval of a crush-resistant version of Opana ER (oxymorphone). Drug abusers often crush opioid pills in order to smoke, inhale or inject them. Endo developed the new formulation of the drug, scheduled for launch in 2012, using Grunenthal's Intac technology. The new version will otherwise be identical to the old one.

"FDA's approval of this new formulation of Opana ER is an important milestone for both the long-acting opioid category as well as Endo's branded pharmaceutical portfolio," Endo EVP research and development and chief scientific officer Ivan Gergel said. "Patient safety is our top concern, and addressing appropriate use of opioids is a responsibility that we take very seriously."


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