Acurox regulatory update

Acura and King plan to submit an NDA early next year for Acurox oxycodone without niacin after an FDA panel voted against approval of Acurox with niacin last month due in part to concerns about niacin's ability to sufficiently deter abuse (see BioCentury, April 26). Without niacin, which causes unpleasant flushing if taken at higher than intended doses, the new formulation would still contain deterrents to prevent intranasal and intravenous abuse. The partners plan to seek the same indication, to treat moderate to severe pain. ...