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Cadence Pharmaceuticals Announces Positive Topline Results of Phase III Clinical Trial of Acetavance in Laparoscopic Surgery
Date:12/17/2008

standard of care for up to five days.

The adult clinical development program for Acetavance is now complete. An analysis of data from nine placebo-controlled, single and repeated dose trials conducted in more than 1,300 adults with acute postoperative pain or fever demonstrated that intravenous acetaminophen has a hepatic safety profile comparable to placebo, with liver function test elevations reported as a treatment-emergent adverse event in 5.0% of subjects who received placebo compared to only 3.1% of subjects who received intravenous acetaminophen.

In addition, the company announced today that Study 102, a clinical trial to evaluate the pharmacokinetics of Acetavance in 75 pediatric patients, demonstrated the expected pharmacokinetic profile, generally comparable to adults, with an age-related reduction in clearance in newborns. Acetavance was well-tolerated across all age groups, ranging from newborns to adolescents. Furthermore, the company announced that it has closed patient enrollment in its last required clinical trial of Acetavance, Study 352, evaluating safety in children after one to five days of repeated doses of Acetavance up to 15 mg/kg. With the results of Study 352, which are expected in the first quarter of 2009, the planned pediatric clinical development program for Acetavance will also be complete.

"We are pleased with the successful completion of studies 304, 351, and 102," stated Ted Schroeder, President and Chief Executive Officer 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."

Conference Call and Webcast on December 17, 2008 at 2:00 p.m. Pacific Time (5:00 p.m. Eastern Time)

Cadence management will host a conference call on December 17, 2008 at 2:00 p.m. Pacific Time (5:00 p.m. Eastern Time). Interested inv
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SOURCE Cadence Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
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