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Cadence Pharmaceuticals Reports First Quarter 2008 Financial Results and Provides Clinical Program Update
Date:5/6/2008

conduct additional trials or modify

its ongoing trials of this product candidate. Cadence currently expects

to receive guidance from the FDA in the second quarter of 2008.

o During the first quarter of 2008, Cadence also implemented several

design enhancements to Study 304, a Phase III clinical trial of

Acetavance for the treatment of acute pain in adults following abdominal

laparoscopic surgery. The trial design modifications included tightening

patient eligibility criteria, performing more frequent pain assessments

and increasing control of opioid medications. Cadence currently expects

to complete enrollment of this clinical trial in the third quarter of

2008 and announce top-line data in the second half of 2008.

o Also during the first quarter of 2008, Cadence initiated a multi-day

safety study of Acetavance in adult patients and a multi-day safety

study of Acetavance in pediatric patients.

o Assuming the successful outcome of Cadence's planned clinical trials for

Acetavance, and FDA concurrence with its proposed clinical development

plan, the company currently expects to submit a 505(b)(2) New Drug

Application (NDA) for this product candidate to the FDA in the first

half of 2009.

Enrollment

Acetavance Clinical Trials Study Phase Status

Treatment of pain following total

knee & hip replacement Sinatra(1) III Completed

Treatment of pain following abdominal

gynecologic surgery 301 III Completed

Treatment of fever in adults (vs. placebo) 302 III Completed

Treatment of fever in adults (onset

of action) 303 III Completed

Adult pharmacokinetics 101
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SOURCE Cadence Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

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