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Cadence Pharmaceuticals Reaffirms FDA-Approved Dosing Recommendations for OFIRMEV® (acetaminophen) Injection
Date:7/28/2011

SAN DIEGO, July 28, 2011 /PRNewswire/ -- Cadence Pharmaceuticals, Inc. (NASDAQ: CADX) today confirmed that the U.S. Food and Drug Administration (FDA) approved dosing recommendations for OFIRMEV® (acetaminophen) injection remains 4,000 mg per day for adults and adolescents weighing at least 50 kg.

Cadence's announcement follows the issuance of a news release by a major manufacturer of over-the-counter (OTC) acetaminophen products announcing its plans to lower the recommended maximum daily dose of some oral acetaminophen products in an effort to reduce the risk of accidental acetaminophen overdose among consumers in the OTC setting.  

"We believe it is important that healthcare providers know that the new recommended dosing guidelines for the OTC products do not affect the recommended dosing guidelines for OFIRMEV," said James Breitmeyer, M.D., Ph.D., Chief Medical Officer of Cadence Pharmaceuticals. "The safety and effectiveness of OFIRMEV at 4,000 mg per day has been well established in numerous clinical trials and is supported by extensive experience with the drug in Europe, where it has been the foundation of IV pain management since its introduction in 2002. Healthcare professionals should continue to administer OFIRMEV as recommended in the FDA-approved package insert."

About OFIRMEV® (acetaminophen) Injection (1000 mg / 100 mL, 10 mg / mL)OFIRMEV (acetaminophen) injection, Cadence Pharmaceuticals' proprietary intravenous formulation of acetaminophen, is indicated for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fever. The FDA approval of OFIRMEV was based on data from clinical trials in approximately 1,020 adult and 355 pediatric patients. These trials included two studies evaluating the safety and effectiveness of OFIRMEV in the tr
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