BioCentury
ARTICLE | Company News

Acura, King to resubmit Acurox without niacin

May 4, 2010 12:28 AM UTC

Acura Pharmaceuticals Inc. (NASDAQ:ACUR) and partner King Pharmaceuticals Inc. (NYSE:KG) 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. 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 (See BioCentury, April 26, 2010). ...