Cadence Pharmaceuticals, Inc. announced today that the FDA has issued a Complete Response letter to its New Drug Application (NDA) for intravenous (IV) acetaminophen.
In the Complete Response letter, the FDA only indicated that deficiencies were observed during the FDA’s facility inspection of Cadence’s third party manufacturer, which was completed on February 5, 2010. The FDA did not cite any safety or efficacy issues, nor did it request any additional studies to be conducted prior to approval.
The Company’s third party manufacturer intends to respond promptly to the observations, and Cadence plans to request a meeting with the FDA to ensure that the deficiencies have been adequately addressed to meet the requirements for NDA approval.
The FDA has also informed the Company that OFIRMEV(TM) has been determined to be an acceptable trade name for IV acetaminophen. The Company is very pleased with label discussions to date and continues to seek approval of OFIRMEV for the management of pain and the reduction of fever in adults and children.
“Cadence is committed to making this important new medicine available to patients and will continue to work closely with the FDA and our third party manufacturer to ensure that the observations are addressed as quickly as possible,” said Ted Schroeder, President and CEO of Cadence. About OFIRMEV (acetaminophen) Injection OFIRMEV 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 OFIRMEV in the United States and Canada in 2006 from Bristol-Myers Squibb, which markets the product as [email protected] in Europe and other parts of the world. IV 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 IV acetaminophen were sold in Europe in 2008 representing an increase of approximately 13 percent over 2007. The NDA for OFIRMEV includes data from two pivotal clinical trials for the treatment of acute pain in patients following orthopedic surgery and abdominal laparoscopic surgery and one pivotal clinical trial for the treatment of fever. The NDA is further 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 1,375 patients who received IV acetaminophen in clinical trials, including 355 pediatric patients, from premature neonates to adolescents, and data from safety reports that collectively represent more than 53 million patient exposures to IV acetaminophen in countries outside the United States.