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news.Pacira Pharmaceuticals, an acute care specialty pharmaceutical company, has completed enrollment in two pivotal Phase III Simple trials to evaluate the safety and efficacy of a single intraoperative administration of Exparel for prolonged postoperative analgesia.
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Results from the studies in hemorrhoidectomy and in total knee arthroplasty are expected to provide the primary clinical data, in addition to extensive existing preclinical and clinical data, for a planned 2009 new drug application (NDA) filing under the FDA 505 (b)(2) regulations.
Pacira is seeking a co-promotion partner for Exparel in the US. Outside the US (except Japan), Exparel is available for licensing in both human and animal health applications. In the US, Pacira intends to commercialize Exparel and its proprietary pipeline products within specialty acute care. Partnerships in the US for both human and animal health to expand the commercialization are currently in development.
Recently, Pacira reported the results of a Phase II total knee arthroplasty study of Exparel. The data showed that the new sustained-release analgesic significantly reduced postoperative pain, opioid use, and reduced opioid-related adverse events compared to the gold standard pain medication.