Cadence Pharmaceuticals Announces Topline Results of Two Phase III Clinical Trials of Acet...(f substantially higherthan predicted var...),Health

Date:1/11/2008

f substantially higher than predicted variability in pain intensity scores. We remain confident in the design of our ongoing Phase III clinical trial of Acetavance for the treatment of pain in adults following abdominal laparoscopic surgery, which commenced enrollment of patients in the fourth quarter of 2007. However, we will request a meeting with the United States Food and Drug Administration (FDA) to obtain the agency's advice regarding our development program for this product candidate."

"Based on the excellent safety results and the positive secondary endpoints in our abdominal gynecologic surgery clinical trial, we remain firmly committed to continuing the development of Acetavance in the United States for the treatment of acute pain and fever," said Ted Schroeder, President and Chief Executive Officer of Cadence. "Our confidence is also supported by other successful post-operative pain trials of intravenous acetaminophen and the product's strong position as the market leading injectable analgesic in Europe, where over 200 million doses have been sold since the product was launched there in 2002."

The abdominal gynecologic surgery trial, referred to as Study 301, was a Phase III, randomized, double-blind, placebo controlled, multi-center, multiple-dose study of the analgesic efficacy and safety of intravenous acetaminophen versus placebo over 48 hours for the treatment of post-operative pain following abdominal gynecologic surgery. Three hundred thirty-one hospitalized patients were enrolled in this study at 27 clinical sites in the United States.

The fever study, referred to as Study 302, was a Phase III, randomized, double-blind, placebo-controlled study of the antipyretic efficacy and safety of intravenous acetaminophen over a six-hour period. In this study, 60 adult patients at one United States clinical trial site received a single dose of Acetavance versus placebo.

Following its planned discussions with the FDA, Cadence will
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SOURCE Cadence Pharmaceuticals, Inc. Copyright©2008 PR Newswire. All rights reserved

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