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Pacira Pharmaceuticals Presents New Data from EXPAREL Phase 3 Study at Orthopaedic Research Society's 57th Annual Meeting
Date:1/13/2011

PARSIPPANY, N.J., Jan. 13, 2011 /PRNewswire/ -- Pacira Pharmaceuticals, Inc., an emerging specialty pharmaceutical company, today announced that new data from its Phase 3 bunionectomy study to evaluate the efficacy and safety of the intraoperative administration of EXPAREL™ (bupivacaine extended-release liposome injection) is being presented in a poster session (number AAOS7) at the 57th Annual Meeting of the Orthopaedic Research Society held from January 13-16, 2011 in Long Beach, California. Study results from this multicenter, randomized, double-blind, parallel-group, placebo-controlled bunionectomy trial demonstrate that 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).

The Phase 3 trial studied 193 subjects in four U.S. centers to determine the safety and efficacy of a single administration of EXPAREL for prolonged postoperative analgesia in subjects undergoing first metatarsal osteotomy (bunionectomy).

Previously disclosed Phase 3 findings in this study showed EXPAREL met its primary endpoint, with a statistically significant reduction in area under the curve analysis (AUC) of the pain intensity numeric rating scale (NRS) scores in subjects receiving EXPAREL compared with placebo (p=0.0005) over the first 24 hours following surgery. EXPAREL is a novel long-acting, sustained-release analgesic formulation of bupivacaine HCl. Bupivacaine HCl is widely used for treating postsurgical pain.

Additional key findings from the Phase 3 study being presented include:

  • A larger percentage of patients treated with EXPAREL avoided opioid rescue medication during the first 24 hours after surgery compared to placebo (7% vs. 1%; p<0.05);
  • Statistically, significantly more patients treated with EXPAREL were pain-free at 2, 4, 8 and 48 hours compared to placebo (p<0.05);
  • Statistically, significan
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  • SOURCE Pacira Pharmaceuticals, Inc.
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