Remoxy Meets Primary Endpoint in Study

Pain Therapeutics and King Pharmaceuticals reported results of a Phase III study of Remoxy, an abuse-deterrent version of long-acting oxycodone, in patients with chronic pain.

 

The 412-patient, randomized, double-blind, placebo-controlled, multicenter Phase III study evaluated the analgesic efficacy of twice-daily Remoxy versus placebo over a 12-week period.

The primary endpoint was defined as mean decrease in pain intensity scores between Remoxy and placebo. Top-line data indicate the study achieved a statistically significant result in its primary endpoint, Pain Therapeutics said.

Pain Therapeutics expects to file a new drug application for Remoxy in the second quarter of 2008.