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Cadence Pharmaceuticals Announces Topline Results of Two Phase III Clinical Trials of Acetavance(TM)
Date:1/11/2008

SAN DIEGO, Jan. 11 /PRNewswire-FirstCall/ -- Cadence Pharmaceuticals, Inc. (Nasdaq: CADX) today announced top line results of two of the company's four pivotal, Phase III clinical trials of Acetavance(TM), a formulation of acetaminophen for intravenous use. One of these clinical trials did not meet its primary endpoint of demonstrating a statistically significant reduction in patients' pain intensity levels over 48 hours compared to placebo, following abdominal gynecologic surgery. However, this same study successfully achieved several secondary endpoints, including pain relief, global patient satisfaction and time to rescue medication. Cadence also announced that its Phase III clinical trial of Acetavance in fever successfully met the primary endpoint, demonstrating a statistically significant reduction of fever over six hours compared to placebo.

Importantly, Acetavance demonstrated a safety profile in both of these clinical trials that was no different than placebo, including the evaluation of eight doses over a 48-hour period. The overall safety profile of Acetavance compares favorably with published safety data on oral acetaminophen, which is generally considered safer than a number of other pain medications currently used in the hospital setting.

"We are very pleased that the fever trial met its primary endpoint, that Acetavance was found to be safe and well-tolerated in both studies, and that there were strong positive results for several secondary endpoints in the pain trial," said James Breitmeyer, M.D., Ph.D., Executive Vice President, Development and Chief Medical Officer of Cadence. "We believe that our clinical trial in patients undergoing abdominal gynecologic surgery did not meet its primary endpoint because o
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SOURCE Cadence Pharmaceuticals, Inc.
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