Cadence Pharmaceuticals Announces Priority Review and Acceptance of NDA Submission for Acetavance(TM) for Treatment of Acute Pain...( SAN DIEGO July 15 /...),Health

SAN DIEGO, July 15 /PRNewswire-FirstCall/ -- Cadence Pharmaceuticals, Inc. (Nasdaq: CADX) announced today that its New Drug Application (NDA) for Acetavance(TM) (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 U.S. 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 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," 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 orthopedic 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
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