Cadence reports positive topline results from Phase III pain trial

Study 304 successfully met its primary endpoint of a statistically significant reduction in summed pain intensity differences from baseline over 24 hours (SPID24) for Acetavance 1000mg compared to placebo (p < 0.01). Study 304 was a randomized, double-blind, multi-center study of 244 patients designed to evaluate the safety and efficacy of two dosing regimens of Acetavance, 1000mg every six hours and 650mg every four hours, compared to placebo over 24 hours. In addition to the 1000mg dose administered every six hours meeting the primary endpoint, the trial also achieved a statistically significant reduction in SPID24 for the 650mg dose administered every four hours (p = 0.02). Consistent with other placebo-controlled clinical trials with intravenous acetaminophen, reported safety events from the Acetavance and placebo treated patients were similar, the company said. Cadence has also announced that Study 351, a clinical trial evaluating the safety of repeated doses of Acetavance in adults, demonstrated a hepatic and general safety profile of Acetavance comparable to control, with numerically lower proportions of subjects with elevated liver function tests in the two Acetavance groups compared to the standard of care group. Study 351 was an open-label, multi-center study of 213 hospitalized patients randomized to receive repeated doses of Acetavance 1000mg every six hours, Acetavance 650mg every four hours, or standard of care for up to five days. Ted Schroeder, president and CEO of Cadence. "The Acetavance new drug application for the treatment of acute pain and fever in both adults and children remains on track for submission during the second quarter of 2009."