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"The completion of patient enrollment in this clinical trial is animportant milestone for Cadence," said Ted Schroeder, President and ChiefExecutive Officer of Cadence. "We believe that intravenous acetaminophen hasthe potential to meet a significant unmet medical need for an effectiveintravenous analgesic to treat acute pain and fever without the unwanted sideeffects associated with currently available treatments."
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Cadence's pivotal trial of IV acetaminophen for the treatment of painfollowing gynecologic surgery, referred to as the IV APAP 301 Study, is arandomized, double-blind, placebo-controlled study in which a total of 331subjects have been enrolled at 27 sites throughout the United States. Patientswere treated with either IV acetaminophen or placebo in the 48-hour periodfollowing gynecologic surgery. The primary endpoint of the trial is analgesicefficacy, measured by reduction in pain intensity, compared to placebo.
"The IV APAP 301 Study is a critical element of our registration programfor IV acetaminophen in the United States," said James Breitmeyer, M.D.,Ph.D., Executive Vice President, Development and Chief Medical Officer ofCadence. "With enrollment completed two months ahead of schedule, we are ontrack to announce top-line results of this study in early 2008, and wecontinue to make excellent progress with our other clinical trials of thisproduct candidate."
About the IV Acetaminophen Clinical Development Program
Cadence's clinical development program for IV acetaminophen consists ofthree pivotal Phase III efficacy trials, two safety studies, and twopharmacokinetic studies, as set forth below:
The company anticipates completing 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 SquibbCompany, is conducting a randomized trial of IV acetaminophen for marketingpurposes 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 efficacystudy for its New Drug Application (NDA) submission.
Assuming successful completion of the planned clinical trials, Cadenceexpects to submit a 505(b)(2) NDA to the U.S. Food and Drug Administration inthe second half of 2008 requesting marketing approval of IV acetaminophen foracute pain and fever in adults and children.
About IV Acetaminophen
IV acetaminophen is a proprietary, intravenous formulation ofacetaminophen. In oral form, acetaminophen is the most widely used medicationin history for the treatment of pain and fever in the United States. Beforethe development of this intravenous formulation of acetaminophen, poorstability in aqueous solutions and inadequate solubility had prevented thedevelopment of an intravenous dosage form. IV acetaminophen has beenpreviously studied in six completed Phase III trials, and Bristol-Myers Squibbhas marketed the product since mid-2002 in Europe, where over 200 millionvials of the drug have been sold since launch and it is the market leaderamong all injectabl
