10450 Science Center Drive
San Diego, CA 92121
(858) 625 2424
5 Sylvan Way
Parsippany, NJ 07054
(973) 254 3560
Several Phase II studies of EXPAREL™ have been completed and have shown effective pain control in soft tissue and bone surgery, in four different surgical models. In these studies, no safety issues were found, even at the highest doses studied for pain control.
Ongoing Phase III studies support an NDA and an EMEA filing in 2010. Additional clinical work in nerve block, non-surgical infiltration, and intraarticular administration of EXPAREL is planned. Clinical development for Japan is being conducted by Pacira's partner, Maruho.
Since bupivacaine is a well characterized molecule, Pacira intends to file in the U.S. with a 505(b)(2) application. Our confidence rests in the approvals by multiple global regulatory
bodies for our other products incorporating the company's proprietary DepoFoam® technology.