In December 2010, Pacira announced that its New Drug Application (NDA) for EXPAREL had been accepted for filing by the U.S. Food and Drug Administration (FDA). Pacira submitted the EXPAREL NDA in September 2010 for the initial indication of postsurgical analgesia by local administration. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of July 28, 2011 for the review of the EXPAREL NDA.

About EXPAREL™EXPAREL is Pacira's proprietary drug candidate consisting of bupivacaine encapsulated in DepoFoam®, both of which are currently used separately in FDA-approved products. Bupivacaine is a well-characterized anesthetic/analgesic that has an established safety profile with more than 20 years of use in the United States. Several Phase 2 and Phase 3 clinical trials have been completed for EXPAREL and demonstrate statistically significant reduction of pain in soft tissue and orthopedic surgery in different surgical models. Clinical data has also demonstrated that EXPAREL provides analgesia for up to 72 hours post-surgery compared with 7 hours or less for bupivacaine. The safety of EXPAREL was evaluated in 10 randomized, double-blind, local administration into the surgical wound clinical studies involving 823 patients; the most common adverse events following EXPAREL administration were nausea, constipation, and vomiting.