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 FDA okays Endo's crush-resistant formulation of Opana

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PostSubject: FDA okays Endo's crush-resistant formulation of Opana   Thu Dec 15, 2011 6:06 pm


Dec 12 (Reuters) - Endo Pharmaceuticals Holdings Inc said U.S. health regulators approved a new crush-resistant formulation of its pain drug Opana, sending the specialty drugmaker's shares up as much as 7 percent.

Opana contains oxymorphone, a morphine-like opioid, which can cause addiction and lead to overdose and death, if used inappropriately. An opioid pill can be misused by crushing it into powder for snorting or injecting into the bloodstream.

The new formula, developed using technology from German pharmaceutical company Grunenthal, makes it extremely difficult to crush and powder the pill.

"If you hit it with a hammer on a table, or squish it between two spoons, it may change shape but it will not powder," Endo's Chief Scientific Officer Ivan Gergel told Reuters.

The crush-resitant formulation is a new version of Opana ER, an extended-release form of the drug, approved in 2006 for patients requiring pain relief over a period of time.

In January, the U.S. Food and Drug Administration had declined to approve an earlier formulation of the drug and sought additional data on its risk management and crush-resistant properties.

The company plans to replace its older formulation with the new pills in 2012.

Endo said it expects to get a U.S. patent on the new formulation on Tuesday, expected to remain effective through 2023.
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