Cadence Pharmaceuticals Announces the Availability of OFIRMEV® (acetaminophen)
Injection through the VA National Formulary
SAN DIEGO, March 12, 2013
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
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 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
Cadence^® and OFIRMEV^® are trademarks of Cadence Pharmaceuticals, Inc.
Contact: William R. LaRue Kelli France
SVP & Chief Financial Officer Media Relations
Cadence Pharmaceuticals, Inc. WCG
Phone: 858-436-1400 Phone: 415-946-1076
SOURCE Cadence Pharmaceuticals, Inc.
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