Cadence Pharmaceuticals, Inc. announced the launch of Ofirmev (acetaminophen) injection, the first and only intravenous (IV) formulation of acetaminophen to be approved in the United States. The US 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, and the reduction of fever. Ofirmev is now available to hospitals across the US.
“With the launch of Ofirmev, physicians will have access to the first new class of IV pain medication in nearly two decades,” said Ted Schroeder, president and CEO of Cadence. “Our focus now turns to working closely with hospitals and physicians to expand access and utilization and establish Ofirmev as a foundational therapy in the management of pain in hospitalized patients. At this initial stage of commercialization, we are pleased with the early signals of physician demand and formulary access. We anticipate that by the end of this year Ofirmev will be on formulary at approximately 800-1,000 hospitals, which will represent approximately half of the IV analgesic opportunity.”
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 centres across the US 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 Keith Candiotti, MD, Professor of Anaesthesiology at the University of Miami. “The safety and effectiveness of IV acetaminophen has been well established in numerous clinical trials and has become the foundation of IV pain management in Europe since its introduction in 2002. I believe that Ofirmev will meet a longstanding unmet need in the US and expect it to play a prominent role in the treatment of pain not only in my practice, but across the US.”
Ofirmev (acetaminophen) injection is Cadence Pharmaceuticals' proprietary intravenous formulation of acetaminophen. The FDA approval of Ofirmev was based on data from clinical trials in which a total of 1,020 adult and 355 paediatric patients received IV acetaminophen. These trials included two studies evaluating the safety and effectiveness of Ofirmev in the management of pain, and one study evaluating Ofirmev in the treatment of fever.
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 paediatric patients. The antipyretic effects of Ofirmev may mask fever in patients treated for post-surgical pain.
Cadence Pharmaceuticals, Inc. is a biopharmaceutical company committed to in-licensing, developing and commercializing proprietary product candidates to improve the lives of hospitalized patients.