its ongoing trials of this product candidate. Cadence currently expects
to receive guidance from the FDA in the second quarter of 2008.
o During the first quarter of 2008, Cadence also implemented several
design enhancements to Study 304, a Phase III clinical trial of
Acetavance for the treatment of acute pain in adults following abdominal
laparoscopic surgery. The trial design modifications included tightening
patient eligibility criteria, performing more frequent pain assessments
and increasing control of opioid medications. Cadence currently expects
to complete enrollment of this clinical trial in the third quarter of
2008 and announce top-line data in the second half of 2008.
o Also during the first quarter of 2008, Cadence initiated a multi-day
safety study of Acetavance in adult patients and a multi-day safety
study of Acetavance in pediatric patients.
o Assuming the successful outcome of Cadence's planned clinical trials for
Acetavance, and FDA concurrence with its proposed clinical development
plan, the company currently expects to submit a 505(b)(2) New Drug
Application (NDA) for this product candidate to the FDA in the first
half of 2009.
Acetavance Clinical Trials Study Phase Status
Treatment of pain following total
knee & hip replacement Sinatra(1) III Completed
Treatment of pain following abdominal
gynecologic surgery 301 III Completed
Treatment of fever in adults (vs. placebo) 302 III Completed
Treatment of fever in adults (onset
of action) 303 III Completed
Adult pharmacokinetics 101
|SOURCE Cadence Pharmaceuticals, Inc.|
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