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12:00 AM
Apr 26, 2010
 |  BioCentury  |  Regulation

Hot and bothered

FDA panel rebuffs Acurox oxycodone, troubled by use of niacin to deter abuse

For most opioid painkillers with abuse-resistance technologies, the challenge has been how to demonstrate to FDAthe formulation does enough to actually reduce abuse and diversion in the real world. The irony of last week's FDA panel to discuss Acurox immediate-release oxycodone from Acura Pharmaceuticals Inc. and King Pharmaceuticals Inc. is that the product would have had a better shot had the sponsors dialed back their approach to abuse prevention.

The companies believed combining immediate-release (IR) oxycodone with niacin, which has unpleasant side effects at high doses, represented an incremental benefit over the opioid alone. But the committee expressed both doubts about nia-cin's effectiveness as a deterrent, and concern that it might cause tolerability issues for patients in need of analgesia.

The vote was 19-1 against recommending approval.

Acurox is formulated in two dosage strengths containing 5/30 and 7.5/30 mg of oxycodone/niacin to be taken two at a time every six hours. The idea was that the addition of sub-therapeutic amounts of niacin, which causes unpleasant flushing if taken at higher than intended doses, would discourage abuse of the product by those seeking to take it orally.

The fixed-dose combination tablets also incorporate the company's Aversion abuse deterrence technology,...

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