Cadence Pharmaceuticals Announces Topline Results of Two Phase III Clinical Trials of Acet...(provideupdated guidance if there is any ...),Health

Date:1/11/2008

provide updated guidance if there is any change to the anticipated timing for submission of a New Drug Application for Acetavance, or if any additional clinical trials are required. The company also intends to disclose more detailed results of both Study 301 and Study 302 clinical trials in an appropriate medical or scientific setting after the completion of data analysis for the two studies.

Update Regarding Other Clinical Trials

Cadence expects to announce the results of a second study of Acetavance for the treatment of fever in adults, referred to as Study 303, later in the first quarter of 2008. This study is intended to assess the speed of onset of fever reduction of Acetavance compared to orally-administered acetaminophen in 81 patients at one U.S. clinical trial site.

In the fourth quarter of 2007, Cadence initiated enrollment in a Phase III clinical trial of Acetavance for the treatment of mild-to-moderate acute pain in adults following abdominal laparoscopic surgery. This randomized, double- blind, multi-center study of 240 patients, referred to as Study 304, is designed to evaluate the safety and efficacy of 24 hours of Acetavance therapy, administered as either a 1000 mg dose every six hours or as a 650 mg dose every four hours, compared to placebo. The purpose of Study 304 is to provide data on the use of Acetavance in a mild-to-moderate acute pain model, as well as information on the safety and efficacy of this product candidate at two different doses and dosing intervals. The company currently anticipates completing enrollment of this study in the second quarter of 2008.

Data from a previously completed, successful pivotal clinical trial in moderate-to-severe orthopedic pain will be submitted to FDA as part of the basis for approval of an NDA for Acetavance (Sinatra, R., et al. Anesthesiology, 2005; 102(4):822-31). Additionally, Cadence plans to initiate two multi-day safety studies of Acetavance, one study in adults and the
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SOURCE Cadence Pharmaceuticals, Inc. Copyright©2008 PR Newswire. All rights reserved

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