Phase III Studies of EXPAREL(TM) (DepoBupivacaine) from Pacira Complete ...( PARSIPPANY N.J. Jan. 6 /- Pacira ...),Health

PARSIPPANY, N.J., Jan. 6 /PRNewswire/ -- Pacira Pharmaceuticals, Inc., an acute care specialty pharmaceutical company, announced today that enrollment has been completed in two pivotal Phase III SIMPLE trials to evaluate the safety and efficacy of a single intraoperative administration of EXPAREL(TM) (DepoBupivacaine) for prolonged postoperative analgesia.

Results from the studies in hemorrhoidectomy and in total knee arthroplasty (TKA) are expected to provide the primary clinical data, in addition to extensive existing preclinical and clinical data, for a planned 2009 NDA filing under U.S. Food and Drug Administration 505 (b)(2) regulations.

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EXPAREL, a proprietary product from Pacira Pharmaceuticals, is a novel long-acting, sustained-release formulation of bupivacaine, a local anesthetic widely used for treating postoperative pain. EXPAREL is being studied in several different types of surgical procedures where postoperative pain management is especially problematic and where the need for prolonged analgesia with a single intraoperative administration can provide a significant improvement in pain relief -- especially during the first 72-hours following surgery -- while also minimizing the need for opioids. With improved prolonged postoperative pain management and a reduction in opioid consumption, Pacira believes patients treated with EXPAREL will experience better pain management and have fewer opioid-related side effects such as nausea and vomiting, and improved outcomes overall.

Recently, Pacira reported the results of a Phase II TKA study of EXPAREL at the International College of Surgeons meeting in Vienna, Austria. The data showed the new sustained-release analgesic significantly reduced postoperative pain, opioid
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