Remoxy Meets Primary Endpoint in Study
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.