Wednesday, Cadence Pharmaceuticals, Inc. (CADX) said that its new drug application, or NDA, for investigational pain and fever medication, Acetavance, has been accepted for filing by the U.S. Food and Drug Administration, or FDA, and designated for priority review. Consequently, the target review period for the NDA is reduced to six months from ten months.
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.
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 said it acquired 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.
The company's NDA for Acetavance includes data from one pivotal clinical trial for the treatment of acute pain in patients following orthopedic surgery and one pivotal clinical trial for the treatment of endotoxin-induced fever. The application 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.
Further, the submission includes safety data from over 1,400 patients who received Acetavance in clinical trials and data from safety reports that collectively represent more than 53 million patient exposures to intravenous acetaminophen in countries outside the United States.
President and Chief Executive Officer Ted Schroeder noted, "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 fulfill 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 U.S. treatment paradigm."
CADX closed yesterday's regular trading at $10.44 on the Nasdaq.
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