Cadence Pharmaceuticals Completes Enrollment of Pivotal Phase III Trial for Intravenous Acetaminophen Ahead o...(pleting enrollment in the two remainingp...),Health

Date:8/30/2007

pleting enrollment in the two remaining, planned Phase III efficacy trials of IV acetaminophen by the end of 2007. Additionally, Cadence's licensor for IV acetaminophen, Bristol-Myers Squibb Company, is conducting a randomized trial of IV acetaminophen for marketing purposes in Europe in patients undergoing total hip replacement surgery. Cadence expects that data from this trial may be available in 2008; however, Cadence does not plan to rely on this clinical trial as a pivotal efficacy study for its New Drug Application (NDA) submission.

Assuming successful completion of the planned clinical trials, Cadence expects to submit a 505(b)(2) NDA to the U.S. Food and Drug Administration in the second half of 2008 requesting marketing approval of IV acetaminophen for acute pain and fever in adults and children.

About IV Acetaminophen

IV acetaminophen is a proprietary, intravenous formulation of acetaminophen. In oral form, acetaminophen is the most widely used medication in history for the treatment of pain and fever in the United States. Before the development of this intravenous formulation of acetaminophen, poor stability in aqueous solutions and inadequate solubility had prevented the development of an intravenous dosage form. IV acetaminophen has been previously studied in six completed Phase III trials, and Bristol-Myers Squibb has marketed the product since mid-2002 in Europe, where over 200 million vials of the drug have been sold since launch and it is the market leader among all injectable analgesics. In the United States, opioids and ketorolac (a non steroidal anti-inflammatory drug), are the only intravenous analgesics currently available to treat acute post-operative pain and are associated with significant adverse side effects.

About Cadence Pharmaceuticals, Inc.

Cadence Pharmaceuticals is a biopharmaceutical company focused on in-licensing, developing and commercializing proprietary product candidates principally for use in the
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SOURCE Cadence Pharmaceuticals, Inc. Copyright©2007 PR Newswire. All rights reserved

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