Cadence Pharmaceuticals Announces Positive Topline Results of Phase III Clinical Trial of Acetavance in Laparoscop... ( SAN DIEGO Dec. 17 /- Cadence Pharmace...)

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Cadence Pharmaceuticals Announces Positive Topline Results of Phase III Clinical Trial of Acetavance in Laparoscopic Surgery

Date:12/17/2008

SAN DIEGO, Dec. 17 /PRNewswire-FirstCall/ -- Cadence Pharmaceuticals, Inc. (Nasdaq: CADX) today announced positive topline results from Study 304, a Phase III clinical trial of Acetavance(TM), the company's intravenous formulation of acetaminophen, for the treatment of acute pain following abdominal laparoscopic surgery. 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 1000 mg 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, 1000 mg every six hours and 650 mg every four hours, compared to placebo over 24 hours. In addition to the 1000 mg 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 plans to communicate the full study results in a peer-reviewed venue.

Cadence also announced today 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 (standard of care), 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
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