Ph III Acurox trial enrolled

US drugmakers King Pharmaceuticals and Acura Pharmaceuticals have announced the completion of patient enrollment for the pivotal Phase III clinical trial evaluating Acurox tablets for relief of moderate-to-severe pain. The companies expect to report top-line results from this pivotal trial by July and submit a New Drug Application to the Food and Drug Administration before the end of this year.

Acurox, an immediate-release tablet, is a proprietary composition of oxycodone HCl, niacin and functional inactive ingredients intended to relieve moderate-to-severe pain and resist or deter common methods of prescription drug abuse, including intravenous injection of dissolved tablets, nasal snorting of crushed tablets and intentional swallowing of excessive numbers of tablets.

Eric Carter, chief science officer of King, commented: "this development milestone is an important measure of our continued success in advancing exciting projects to further expand our pain management franchise. We expect that Acurox tablets will be the first approved immediate-release opioid analgesic designed to resist or deter common methods of prescription drug abuse."