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news.Acura Pharmaceuticals and King Pharmaceuticals have announced positive top-line results from Acura's pivotal Phase III study. Both strengths of Acurox tablets met the primary pain relief endpoint compared to placebo.
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The Phase III study (study 105) was a randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of Acurox tablets for relief of moderate to severe pain following bunionectomy surgery.
A total of 405 patients were randomized to one of three treatment arms of approximately 135 patients per arm. One treatment arm received a dose of two Acurox (oxycodone HCl/niacin) tablets 5/30mg, a second treatment arm received a dose of two Acurox tablets 7.5/30mg, and the third treatment arm received a dose of two placebo tablets.
Study drugs were administered every six hours. The primary endpoint was the sum of the difference in pain intensity, measured on a 100mm visual analog scale (VAS), compared to baseline over a 48 hour period.
Both Acurox tablet strengths met the primary endpoint: p=.0001 for Acurox tablets 5mg/30mg and p less than.0001 for Acurox tablets 7.5mg/30mg.
Acura and King expect to submit a new drug application for Acurox tablets to the FDA by the end of 2008 with a targeted indication for the relief of moderate to severe pain where the use of an immediate release, orally administered, opioid analgesic tablet is appropriate.