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Pacira Pharmaceuticals, Inc. Announces Phase 3 EXPAREL™ Data Presentation at the American Society of Colon and Rectal Surgeons 2011 Annual Meeting
Date:5/16/2011

one as we execute on our clinical and pre-commercial strategies."

Key findings from this study include:

  • The study met its primary endpoint with a statistically significant reduction in cumulative pain score in patients receiving EXPAREL compared to placebo (p<0.0001).
  • A total of 189 patients were treated at 12 clinical sites in Europe.
  • The percentage of patients who were entirely opioid free was higher (p<0.0008) with EXPAREL than with placebo.
  • The median time to first opioid rescue was 14 hours and 20 minutes in the EXPAREL group, more than 10 times longer than the placebo group (1 hour and 10 minutes) (p<0.0001).
  • EXPAREL patients consumed statistically significantly less opioid rescue medication through 72 hours compared to the placebo group (p=0.0006).

In addition, the study showed that EXPAREL was well tolerated, with the incidence of adverse events (AEs) similar to placebo. GI side effects, commonly associated with opioid use, were reduced in the EXPAREL group compared to placebo, and there were no serious adverse events (SAEs) reported in patients receiving EXPAREL. Overall, 94.7% of patients treated with EXPAREL were "satisfied" or "extremely satisfied" with their postsurgical analgesia at 72 hours compared with 73.9% in the placebo group (p<0.0007).

There were no deaths or withdrawals due to an AE in the study.  There was one SAE (mild thrombophlebitis), which occurred in a patient who had received placebo, and was resolved the next day after treatment. The most common AEs experienced were gastrointestinal in nature, occurring in 8.4% of EXPAREL patients and 13.8% of placebo patients. 

For more information or to view the full poster, please visit the scientific presentations page located in the investors and media section on the Pacira website at www.pacira.com.

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SOURCE Pacira Pharmaceuticals, Inc.
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