Federal health advisers have overwhelmingly voted against a proposed painkiller from the maker of OxyContin due to risks of overdose.
Purdue Pharma is seeking FDA approval to market a harder-to-abuse version of the immediate-release drug oxycodone. The company already sells an extended-release formulation of the drug OxyContin, which is designed to thwart crushing or snorting.
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But Food and Drug Administration panelists said an issue that delays the drug's absorption when taken with food poses a safety risk. The experts said it was unlikely patients would follow instructions to take the drug on an empty stomach. Instead patients could wind up taking multiple doses if they don't get the prompt pain relief they expect.
The panel voted 23-1 against approving the drug. The vote is a non-binding recommendation to the FDA.