"With the launch of OFIRMEV, physicians will have access to the first new class of IV pain medication in nearly two decades," said
The national launch of OFIRMEV is being supported by 147 hospital sales specialists and 13 field medical science liaisons. These field personnel have extensive hospital experience and have completed rigorous training in preparation for the launch. Through agreements with the three major pharmaceutical wholesalers, distribution centers across the U.S. are fully stocked and accepting orders from hospitals.
Until now, the only injectable drugs available to treat pain and fever were opioids and NSAIDs. When used as part of a multi-modal approach to pain management in placebo-controlled clinical studies, OFIRMEV demonstrated significant pain relief, reduced the consumption of opioids, and improved patient satisfaction. OFIRMEV is also the first and only IV medication indicated for the treatment of pain and fever in children two years of age and older.
"We have long needed better tools to improve pain management in hospitalized patients," said
Conference Call and Webcast Details
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About OFIRMEV™ (acetaminophen) Injection
OFIRMEV (acetaminophen) injection is
Important Safety Information:
OFIRMEV should be administered only as a 15 minute intravenous infusion. 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. 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.
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 commercial launch of OFIRMEV; the anticipated U.S. market opportunity for IV acetaminophen; the ability of OFIRMEV to fill unmet medical needs and achieve formulary and market acceptance; and our strategy for building a long-term hospital pain franchise. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Actual future results may differ materially from our current expectations due to the risks and uncertainties
inherent in Cadence's business. These risks include our dependence on the successful commercialization of OFIRMEV; the risk that delays in commercially launching or achieving formulary acceptance for OFIRMEV at a substantial number of targeted accounts would enable competitors to further entrench their products and decrease the market potential for OFIRMEV; our ability to ensure an adequate and continued supply of OFIRMEV to successfully launch commercial sales or meet anticipated market demand; OFIRMEV remains subject to substantial, ongoing regulatory requirements; our ability to comply with the terms of our loan agreement; the potential for an event of default under our loan agreement, and the corresponding risk of acceleration of repayment and potential foreclosure on the assets pledged to secure the line of credit; the potential that we may be required to file a lawsuit to defend
our patent rights or regulatory exclusivities from challenges by companies seeking to market generic versions of intravenous acetaminophen; our ability to successfully enforce our intellectual property rights and defend our patents; the impact of healthcare reform legislation; the potential that we will require substantial additional funding in order to successfully commercialize OFIRMEV, and the risk that we 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 Quarterly Report on Form 10-Q for the period ended
Cadence® and OFIRMEV™ are trademarks of
Cadence Pharmaceuticals, Inc.
William R. LaRue, SVP and Chief Financial Officer
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