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Cadence Pharmaceuticals Reports Fourth Quarter and Full Year 2007 Financial Results and Provides Corporate and Clinical Program Overview
Date:3/12/2008

ns, Cadence may conduct additional clinical trials or

modify its ongoing clinical trials of this product candidate.

-- In the fourth quarter of 2007, Cadence initiated enrollment in Study

304, a pivotal, Phase III clinical trial of Acetavance for the

treatment of acute pain in adults following abdominal laparoscopic

surgery. This randomized, double-blind, multi-center study of 240

patients is designed to evaluate the safety and efficacy of Acetavance

administered over 24 hours as a 1000 mg dose every six hours and as a

650 mg dose every four hours, compared to placebo. Cadence has recently

implemented several design enhancements to this study, including

tightening patient eligibility criteria, performing more frequent pain

assessments and increasing control of opioid medications. The purpose

of Study 304 is to provide data on the use of Acetavance in a moderate

pain model, as well as information on the safety and efficacy of this

product candidate at two different doses and dosing intervals. Cadence

currently anticipates completing enrollment in this clinical trial in

the third quarter of 2008, and announcing top-line data in the second

half of 2008.

-- Cadence expects to announce the results of Acetavance Study 303 for the

treatment of fever in adults in the second quarter of 2008. This

non-pivotal study is intended to assess the speed of onset of

anti-pyretic action of Acetavance compared to orally-administered

acetaminophen in 81 patients at one U.S. clinical trial site.

-- Cadence has initiated a multi-day safety study of Acetavance in adults,

and plans to initiate a safety study in pediatric patients, in the

first quarter of 2008.

-- Cadence currently anticipates the submission of a 505(b)(2) NDA for

Acetavance to the U.S. Food and D
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SOURCE Cadence Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
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