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FDA to review Purdue's attempt at tamper-resistant OxyContin

5/5/2008

WASHINGTON The Food and Drug Administration is evaluating a new version of Purdue Pharma’s painkiller OxyContin, according to the Associated Press.

The new version would have a plastic-like coating fused to the tablet, making it harder to crush, which it would be harder for people to use it incorrectly to receive a euphoric high.

The FDA will ask its scientific advisers on Monday if the reformulated drug seems tamper-resistant enough to allow on the market, before the required long-term studies are done to see if the changes thwart at least some abuse.

Purdue Pharma said its laboratory studies show the new OxyContin is equivalent to the original in how well the painkiller dissolves if used correctly.

But the agency still has questions concerning how addicting the medication is and whether this new formulation will solve this problem in any way.

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