Cadence Pharmaceuticals Inc has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its investigational product candidate Acetavance (intravenous acetaminophen) for the treatment of acute pain and fever in adults and children. If approved, Acetavance would become the first new intravenous analgesic approved in the United States in more than 20 years and the only approved intravenous agent for the treatment of fever in the United States.

"Submission of the Acetavance NDA is a major milestone for Cadence and demonstrates our commitment to develop products that address unmet needs in the hospital market," said Ted Schroeder, president and chief executive officer of Cadence. "We believe that the data supporting the NDA for Acetavance are strong and look forward to working with the FDA throughout the regulatory review process."

The company's 505(b)(2) NDA submission for Acetavance includes data from one pivotal clinical trial for the treatment of acute pain in patients following orthopaedic surgery and one pivotal clinical trial for the treatment of endotoxin-induced fever. The NDA is also supported by data from a total of nine placebo-controlled clinical trials, four active-controlled clinical trials, and seven other safety or pharmacokinetic clinical trials. The submission includes safety data from over 1,400 patients who received Acetavance in clinical trials, including 350 children, and data from safety reports that collectively represent more than 53 million patient exposures to intravenous acetaminophen in countries outside the United States.

Acetavance is Cadence Pharmaceuticals' proprietary intravenous formulation of acetaminophen. Acetaminophen is the most widely used medication for the treatment of pain and fever in the United States and is available in more than 600 combination and single-ingredient prescription and over-the-counter products. Cadence acquired the exclusive rights to Acetavance in the United States and Canada in 2006 from Bristol-Myers Squibb Company, which markets the product as Perfalgan in Europe and other parts of the world. Intravenous acetaminophen is approved in approximately 80 countries, including major markets in Europe, where the product is the market leader among all injectable analgesics. Approximately 90 million vials of intravenous acetaminophen were sold in Europe in 2008.

There is an unmet medical need for new agents to treat pain or fever in hospitalized patients who cannot take medications by mouth. Only two classes of intravenous analgesics, opioids and non-steroidal anti-inflammatory drugs, or NSAIDs, are currently available in the United States for the treatment of acute pain. Opioids may be associated with a variety of unwanted side effects, including respiratory depression, excessive sedation, nausea, vomiting, constipation, cognitive impairment, and others. The only non-opioid intravenous analgesic currently available in the United States is the NSAID, ketorolac. Post-operative use of intravenous ketorolac is limited due to its potential to cause increased bleeding. Renal toxicity and the potential for increased cardiovascular events further limit the post-operative use of NSAIDs. Dipyrone (metamizole) was the last injectable drug for the reduction of fever in the United States, but since it was taken off the market in 1976, there has been no approved parenteral antipyretic drug available.

Cadence Pharma is a biopharmaceutical company focused on in-licensing, developing and commercializing proprietary product candidates principally for use in the hospital setting.