modify its ongoing clinical trials of this product candidate.
-- In the fourth quarter of 2007, Cadence initiated enrollment in Study
304, a pivotal, Phase III clinical trial of Acetavance for the
treatment of acute pain in adults following abdominal laparoscopic
surgery. This randomized, double-blind, multi-center study of 240
patients is designed to evaluate the safety and efficacy of Acetavance
administered over 24 hours as a 1000 mg dose every six hours and as a
650 mg dose every four hours, compared to placebo. Cadence has recently
implemented several design enhancements to this study, including
tightening patient eligibility criteria, performing more frequent pain
assessments and increasing control of opioid medications. The purpose
of Study 304 is to provide data on the use of Acetavance in a moderate
pain model, as well as information on the safety and efficacy of this
product candidate at two different doses and dosing intervals. Cadence
currently anticipates completing enrollment in this clinical trial in
the third quarter of 2008, and announcing top-line data in the second
half of 2008.
-- Cadence expects to announce the results of Acetavance Study 303 for the
treatment of fever in adults in the second quarter of 2008. This
non-pivotal study is intended to assess the speed of onset of
anti-pyretic action of Acetavance compared to orally-administered
acetaminophen in 81 patients at one U.S. clinical trial site.
-- Cadence has initiated a multi-day safety study of Acetavance in adults,
and plans to initiate a safety study in pediatric patients, in the
first quarter of 2008.
-- Cadence currently anticipates the submission of a 505(b)(2) NDA for
Acetavance to the U.S. Food and D
|SOURCE Cadence Pharmaceuticals, Inc.|
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