Cadence Pharmaceuticals, Inc announced that its New Drug Application (NDA) for Acetavance (intravenous acetaminophen), its investigational product candidate for the treatment of acute pain and fever in adults and children, has been accepted for filing by the US Food and Drug Administration (FDA) and designated for Priority Review.
Priority Review is granted to those products that address significant unmet medical needs or have the potential to provide a significant improvement compared to marketed products and provides for a review period of six months from the date of NDA submission. The FDA has issued an action date for the NDA of November 13, 2009 under the Prescription Drug User Fee Act (PDUFA).
"We are very pleased with the FDA's decision to grant the Acetavance NDA a Priority Review, which we believe reflects the potential of Acetavance to fulfil a significant unmet need for a new class of intravenous medication to treat acute pain and fever in adults and children, for which there remains a large gap in the US treatment paradigm," said Ted Schroeder, president and CEO of Cadence.
The Priority Review designation reduces the target review period for the NDA from ten months to six months. Acceptance of the NDA submission indicates that the FDA has made a threshold determination that the NDA is sufficiently complete to permit a substantive review.
The company's 505(b)(2) NDA 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 paediatric patients, from premature neonates to adolescents, 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 Pharma is a biopharmaceutical company focused on in-licensing, developing and commercializing proprietary product candidates principally for use in the hospital setting.