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Positive Phase II Study of Pacira's EXPAREL(TM) (DepoBupivacaine) in Total Knee Arthroplasty Presented at International College of Surgeons World Congress
Date:12/6/2008

Findings as reported in the poster include:

  • Statistically significant reduction in pain versus Bup/epi in patients receiving EXPAREL 450mg at the end of general anesthesia, 5.0 vs. 7.0 pain intensity (P<0.05).
  • Statistically significant reduction in pain at the time of first opioid use in both EXPAREL 300mg and 450mg patient groups versus active control, 6.4 vs. 7.8 pain intensity and 6.1 vs. 7.8 pain intensity respectively (P<0.05).
  • Pain intensity was also lower with EXPAREL than with Bup/epi during activity at all postoperative intervals evaluated.
  • EXPAREL 450mg also significantly decreased the use of opioid rescue medications throughout the entire evaluation period plus postoperative nausea and vomiting occurrence was 40% lower than in the active control group.
    • Approximately 8% of patients in the EXPAREL 450mg group avoided all opioid use versus zero percent (0%) of patients in the active control group.
  • No differences were found in the safety profile of EXPAREL compared with bupivacaine. There were no clinical signs of either cardiac or central nervous system adverse events.

The multi-center, double-blind, randomized Phase II study used a parallel-group, active-control format to evaluate the efficacy and safety of EXPAREL for prolonged postoperative analgesia. Either a single intraoperative administration of EXPAREL or active control was given via local infiltration to 103 adult patients undergoing TKA in 5 centers across the U.S. and Europe.

TKA is the leading orthopedic surgery in the U.S. with approximately 534,000 procedures performed annually according to the National Center for Health Statistics. It is expected that the number of total knee replacement procedures will increase as our population continues to age. <
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SOURCE Pacira Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
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