Pacira Pharma Says EXPAREL Phase 3 Trial Meets Primary Efficacy Endpoint

(RTTNews) - Pacira Pharmaceuticals, Inc. (PCRX) reported that the Phase 3 study evaluating the safety and efficacy of EXPAREL in femoral nerve block for total knee arthroplasty achieved its primary efficacy endpoint.

This pivotal Phase 3 trial assessed 183 patients who were randomized to receive either 266 mg of EXPAREL or placebo, with all patients offered rescue narcotics as needed. Results showed statistical significance in favor of EXPAREL for cumulative pain scores over 72 hours as measured by the area under the curve. The preliminary safety analysis was comparable between the two groups.

Dave Stack, president, chief executive and chairman of Pacira, stated: "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."