Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) today announced that the Phase 3 clinical trial assessing the safety and efficacy of EXPAREL® (bupivacaine liposome injectable suspension) in femoral nerve block for total knee arthroplasty met its primary efficacy endpoint.
This pivotal Phase 3 trial evaluated 183 patients who were randomized to receive either 266 mg of EXPAREL or placebo, with all patients offered rescue narcotics as needed. Results demonstrated statistical significance in favor of EXPAREL for cumulative pain scores over 72 hours as measured by the area under the curve (AUC) (P<0.0001). The preliminary safety analysis was comparable between the two groups.
"We are pleased to report the positive results of the femoral nerve block trial and look forward to filing for a nerve block indication," said Dave Stack, president, chief executive officer and chairman of Pacira. "We believe that the expansion of the EXPAREL label to include nerve block will further enhance its clinical utility and broaden its access among anesthesiologists and surgeons."
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