FDA panel rejects abuse-resistant painkiller
WASHINGTON — Federal health experts say an experimental painkiller designed to discourage misuse is not effective enough to warrant approval.
A panel of Food and Drug Administration experts voted 19-1 against Acura Pharmaceutical’s Acurox, which combines oxycodone with the vitamin niacin. The vitamin is designed to cause irritation and flushing if patients crush the pill to snort, eat or inject.
However panelists were unconvinced by the company’s data, which did not show strong evidence that niacin discouraged abuse.
Panelists pointed out that Acurox’s deterrent effects could be eliminated simply by eating food or taking aspirin.
The FDA is not required to follow the advice of its panelists, though it often does.
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