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Cadence Pharmaceuticals Submits Acetavance New Drug Application for the Treatment of Acute Pain and Fever
Date:5/14/2009

SAN DIEGO, May 14 /PRNewswire-FirstCall/ -- Cadence Pharmaceuticals, Inc. (Nasdaq: CADX) announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational product candidate, Acetavance(TM) (intravenous acetaminophen), for the treatment of acute pain and fever in adults and children. If approved, Acetavance would become the first new intravenous analgesic approved in the United States in more than 20 years and the only approved intravenous agent for the treatment of fever in the United States.

"Submission of the Acetavance NDA is a major milestone for Cadence and demonstrates our commitment to develop products that address unmet needs in the hospital market," said Ted Schroeder, President and Chief Executive Officer of Cadence. "We believe that the data supporting the NDA for Acetavance are strong and look forward to working with the FDA throughout the regulatory review process."

The company's 505(b)(2) NDA submission for Acetavance includes data from one pivotal clinical trial for the treatment of acute pain in patients following orthopedic surgery and one pivotal clinical trial for the treatment of endotoxin-induced fever. The NDA is also supported by data from a total of nine placebo-controlled clinical trials, four active-controlled clinical trials, and seven other safety or pharmacokinetic clinical trials. The submission includes safety data from over 1,400 patients who received Acetavance in clinical trials, including 350 children, and data from safety reports that collectively represent more than 53 million patient exposures to intravenous acetaminophen in countries outside the United States.

Acetavance is Cadence Pharmaceuticals' proprietary intravenous formulation of acetaminophen. Acetaminophen is the most widely used medication
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SOURCE Cadence Pharmaceuticals, Inc.
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