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Pacira Pharmaceuticals Highlights Additional Safety Data on EXPAREL™ for Postsurgical Pain Relief at 2011 American Academy of Orthopaedic Surgeons Annual Meeting
Date:2/15/2011

significantly less opioids were consumed
  • The median time to first use of opioid rescue medication was 7.2 hours for patients treated with EXPAREL compared with 4.3 hours for patients treated with placebo (p<0.0001)
  • A larger percentage of patients treated with EXPAREL avoided any opioid rescue medication during the first 24 hours after surgery compared to placebo (7% vs.1%; p<0.05)
  • EXPAREL was well tolerated in patients who received postsurgical treatment for pain following bunionectomy
  • There were no statistically significant differences between treatment groups in wound assessments (erythema, drainage, edema, and in duration)
  • No patients demonstrated any evidence of malunion or non-union. Follow-up radiographs and documentation of wound healing were collected for 82% of patients four to six weeks post bunionectomy procedures
  • The incidence of adverse events was lower in the EXPAREL group (60%) than in the placebo group (68%); the most common events in both groups were nausea, vomiting, and dizziness

  • "EXPAREL addresses an unmet need in postsurgical pain control, which is the need for a longer-lasting, non-opioid analgesic," said David Stack, president and chief executive officer, Pacira Pharmaceuticals, Inc. "We believe these findings along with previously reported efficacy data continue to differentiate EXPAREL."

    "Based upon the findings of this Phase 3 study, we believe Pacira's DepoFoam® technology enables EXPAREL to safely and effectively extend the duration of pain relief by more than 67% compared with placebo," added Stephen Daniels, D.O., primary study investigator and executive medical director, Premier Research Group Limited, Austin, Texas. "EXPAREL has the potential to be the first FDA-approved long-acting bupivacaine analgesic and should be well positioned to support a standard postsurgical treatment regimen. In addition, EXPAREL's ease-of-use should allow medical professionals
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    SOURCE Pacira Pharmaceuticals, Inc.
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