SAN DIEGO, March 12, 2013 /PRNewswire/ -- Cadence Pharmaceuticals, Inc. (NASDAQ: CADX), announced today that the Department of Veterans Affairs has made OFIRMEV® (acetaminophen) injection available on the VA National Formulary (VANF). The VANF is a list of products (drugs and supplies) generally covered under VA pharmacy benefits. VANF products must be available for prescription at all VA facilities. The purpose of the VANF management process is to provide high quality, best value pharmaceutical products while assuring the portability and standardization of the pharmacy benefit to all eligible veterans accepted by the VA for care.
"We believe that the availability of OFIRMEV on the VANF demonstrates the VA's recognition of the clinical value that OFIRMEV can offer to patients and physicians in the treatment of acute pain and fever. Now, clinicians practicing at VA facilities have access to OFIRMEV for use in a multimodal approach to pain management in the hospital setting," said Ted Schroeder, President and CEO of Cadence.
OFIRMEV is the first non-narcotic, non-NSAID, intravenous analgesic available in the United States. From January 2011 through January 2013, over 6.6 million vials have been distributed to approximately 3,700 acute care facilities.
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.
About Cadence Pharmaceuticals, Inc.
Cadence Pharmaceuticals is a biopharmaceutical company focused on acquiring, in-licensing, developing and commercializing proprietary products principally for use in the hospital setting. The current version of Cadence Pharmaceuticals' corporate overview may be viewed on the Investors page of www.cadencepharm.com under "Events & Presentations" by selecting "Corporate Overview."
Cadence® and OFIRMEV® are trademarks of Cadence Pharmaceuticals, Inc.
William R. LaRue
SVP & Chief Financial Officer
Cadence Pharmaceuticals, Inc.
SOURCE Cadence Pharmaceuticals, Inc.
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