Pacira BioSciences, Inc. announced the publication of its pivotal Phase 3 study supporting the efficacy and safety of EXPAREL (bupivacaine liposome injectable suspension) as a single-dose sciatic nerve block in the popliteal fossa in patients undergoing bunionectomy. The results demonstrate that EXPAREL significantly improved pain control and reduced opioid consumption through 96 hours versus bupivacaine HCl. The data, which provided the basis for FDA approval for this indication was published in the Journal of Clinical Anesthesia.

Key findings for EXPAREL 133 mg versus bupivacaine HCl 50 mg administered as a single-dose sciatic nerve block in the popliteal fossa for patients undergoing bunionectomy demonstrated statistically significant and superior pain control over bupivacaine for 4 days post-surgery: There was a 44% difference in pain scores through 96 hours the study?s primary endpoint as measured by the area under the curve, or AUC, of the Numerical Rating Scale pain intensity scores from 0 to 96 hours post-surgery; P Patients receiving EXPAREL consumed 61% fewer opioids through 96 hours the study?s secondary endpoint LSM total opioid consumption; P · Almost one quarter of patients in the EXPAREL group needed no rescue opioids through 96 hours compared to the bupivacaine group (24.4% versus 6% of patients, respectively). Additionally, patients in the EXPAREL 133 mg arm had approximately five-fold higher odds of being opioid-free compared with the bupivacaine HCl 50 mg arm; P=0.0003 The safety profiles of EXPAREL 133 mg and bupivacaine HCl 50 mg were similar, with a similar proportion of adverse events (AEs) and serious adverse events (SAEs), and all AEs were mild to moderate in severity. In total, the study randomized 185 subjects.

In Part A, 66 subjects undergoing bunionectomy were randomized 1:1:1 to receive a sciatic nerve block in the popliteal fossa with a single dose of EXPAREL 266 mg, EXPAREL 133 mg or 20 mL 0.25% bupivacaine HCl. In part B, an additional 119 subjects undergoing bunionectomy were randomized 1:1 to receive a sciatic nerve block in the popliteal fossa with a single dose of EXPAREL 133 mg or 20 mL 0.25% bupivacaine HCl. All subjects in Part A and Part B received a Mayo field block with 20 mL 0.5% bupivacaine HCl after study drug administration in the operating room immediately prior to surgical incision.

The study?s primary endpoint was the area under the curve, or AUC, of the Numerical Rating Scale pain intensity scores from 0 to 96 hours post-surgery comparing EXPAREL to bupivacaine HCl. Secondary endpoints included total postsurgical opioid consumption from 0 to 96 hours comparing EXPAREL to bupivacaine HCl and percent opioid free from 0-96 hours.