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news.Pacira Pharmaceuticals has released new data from a Phase 3 bunionectomy study evaluating the efficacy and safety of the intraoperative administration of Exparel (bupivacaine extended-release liposome injection).
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Exparel is a novel, sustained-release analgesic formulation of bupivacaine HCl.
The study demonstrated 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.
The Phase 3 multicenter, randomized, double-blind, parallel-group, placebo-controlled trial assesed 193 subjects in four US 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 revealed Phase 3 findings in this study showed Exparel met its primary endpoint, with a reduction in area under the curve analysis (AUC) of the pain intensity numeric rating scale (NRS) scores in subjects receiving Exparel compared with placebo over the first 24 hours following surgery.