Cadence Pharmaceuticals Announces Addition of OFIRMEV® (acetaminophen) Injection to U.S. Military's Joint Deployment Formulary

SAN DIEGO, June 7, 2011 /PRNewswire/ -- Cadence Pharmaceuticals, Inc. (Nasdaq: CADX) announced today that OFIRMEV® (acetaminophen) injection has been added to the U.S. Department of Defense's Joint Deployment Formulary (JDF), the core list of pharmaceutical products required for theater-level care of deployed forces.  The U.S. Food and Drug Administration (FDA) approved OFIRMEV in November 2010 for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics (pain relievers), and the reduction of fever.

The JDF serves as a baseline deployment formulary to treat the most common wounds or diseases that may affect U.S. Armed Forces members.  Through its inclusion on the JDF, OFIRMEV is now available for use in deployed theaters by all four U.S. military service branches.  

"We have been using OFIRMEV routinely since it was placed on our formulary and have found that it improves pain management while reducing narcotic use in the recovery unit," said Major Jonathan Rogers, M.D., Chief of Acute Pain/Regional Anesthesiology at Wilford Hall Medical Center. "With OFIRMEV, we can achieve one of our primary objectives as physicians, which is relieving pain experienced by our patients.  I am confident that OFIRMEV will play an integral role in treating the acute pain related to battlefield injuries and associated procedures."

"We believe that military physicians and the wounded service members they care for deserve access to innovative therapies.  With the rapid addition of OFIRMEV to the JDF formulary, military physicians now have the ability to treat patients with the first new class of IV pain medication in nearly two decades," said Ted Schroeder, President and CEO of Cadence Pharmaceuticals.  "We are proud that OFIRMEV will play a role in treating pain related to injuries sustained by forward combat troops."

About OFIRMEV® (acetaminophen) Injection

OFIRMEV (acetaminophen) injection (1000 mg / 100 mL, 10 mg / mL; for intravenous use only), 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 treatment of pain, and one study evaluating OFIRMEV in the treatment of fever.  The effectiveness of OFIRMEV for the treatment of acute pain and fever has not been studied in pediatric patients less than 2 years of age.

Important Safety Information

Do not exceed the maximum recommended daily dose of acetaminophen. Administration of acetaminophen by any route in doses higher than recommended may result in hepatic injury, including the risk of severe hepatotoxicity and death. OFIRMEV is contraindicated in patients with severe hepatic impairment, severe active liver disease or with known hypersensitivity to acetaminophen or to any of the excipients in the formulation. Acetaminophen should be used with caution in patients with the following conditions: hepatic impairment or active hepatic disease, alcoholism, chronic malnutrition, severe hypovolemia, or severe renal impairment. OFIRMEV should be administered only as a 15 minute intravenous infusion. Discontinue OFIRMEV immediately if symptoms associated with allergy or hypersensitivity occur. Do not use in patients with acetaminophen allergy. The most common adverse reactions in patients treated with OFIRMEV were nausea, vomiting, headache, and insomnia in adult patients and nausea, vomiting, constipation, pruritus, agitation, and atelectasis in pediatric patients. The antipyretic effects of OFIRMEV may mask fever in patients treated for post-surgical pain.

For more information, please see the complete OFIRMEV Prescribing Information, available at www.OFIRMEV.com or www.cadencepharm.com.

About Cadence Pharmaceuticals, Inc.

Cadence Pharmaceuticals is a biopharmaceutical company focused on in-licensing, developing and commercializing proprietary products principally for use in the hospital setting. For more information about Cadence, please visit www.cadencepharm.com.

Forward-Looking Statements

Statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "plans," "believes," "expects," "anticipates," and "will," and similar expressions, are intended to identify forward-looking statements, and are based on Cadence's current beliefs and expectations. Such statements include, without limitation, statements regarding: the anticipated U.S. market opportunity for OFIRMEV, and the ability of OFIRMEV to play an integral role in treating acute pain associated with surgical procedures to treat battlefield injuries. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Cadence's actual future results may differ materially from the company's current expectations due to the risks and uncertainties inherent in its business. These risks include, but are not limited to: Cadence's dependence on the successful commercialization of OFIRMEV, which is the company's only product; the potential that delays in achieving formulary acceptance for OFIRMEV at a substantial number of targeted accounts may enable competitors to further entrench their products and decrease the market potential for OFIRMEV; Cadence's ability to generate revenues from OFIRMEV; the company's ability to ensure an adequate and continued supply of OFIRMEV to meet anticipated market demand; Cadence's ability to fully comply with numerous federal, state and local laws and regulatory requirements that apply to its commercial activities; public concern regarding the safety of drug products such as OFIRMEV, which could result in the potential that regulatory agencies may implement new requirements to include unfavorable information in the labeling for OFIRMEV, or require Cadence to undertake other activities that may entail additional costs or diminish market acceptance of OFIRMEV; the company's ability to successfully enforce its marketing exclusivities and intellectual property rights, and to defend its patents; the potential that Cadence may be required to file lawsuits to defend its patent rights or regulatory exclusivities from challenges by companies seeking to market generic versions of intravenous acetaminophen, and the substantial costs associated with such lawsuits; the potential product liability exposure associated with pharmaceutical products such as OFIRMEV and other products Cadence may in-license or acquire, and the substantial liability the company may face if successful product liability claims are brought against it; the risk that Cadence may not be able to raise sufficient capital when needed, or at all; and other risks detailed under "Risk Factors" and elsewhere in Cadence's periodic reports and other filings made with the Securities and Exchange Commission from time to time. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995, and the company undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.

Cadence® and OFIRMEV® are trademarks of Cadence Pharmaceuticals, Inc.

SOURCE Cadence Pharmaceuticals, Inc.