Phase III study on efficacy and safety of Exparel in post surgical pain control published in Pain Medicine.

Pacira BioSciences announced the publication of its multinational Phase III study supporting the efficacy and safety of Exparel (bupivacaine liposome injectable suspension) as a single-injection interscalene brachial plexus nerve block (ISNB) in patients undergoing total shoulder arthroplasty or rotator cuff repair. The results demonstrate that Exparel significantly improved pain control and reduced opioid consumption through 48 hours compared with placebo and a standardized pain management protocol alone. The study’s primary endpoint was pain intensity scores through 48 hours; secondary endpoints included total postsurgical opioid consumption, percentage of opioid-free patients; and time to first opioid rescue. A total of 140 patients enrolled across 16 surgical centers in the United States, Belgium, and Denmark were randomized to receive an ultrasound-guided single-dose ISNB with either Exparel 133 mg (n=69) or saline placebo (n=71).

Compared to patients receiving placebo, patients in the Exparel group demonstrated a statistically significant: Reduction in pain scores measured using the area under the curve of the visual analog scale pain intensity scores through 48 hours (least squares mean [SE], 136.4 [12.09] vs 254.1 [11.77], respectively; P<0.0001); decrease in total postsurgical opioid consumption, converted to intravenous morphine equivalents, by 78 percent through 48 hours, (least squares mean [SE], 12.0 mg [2.27] vs 54.3 mg [10.05], respectively; P<0.0001); Higher percentage of opioid-free patients at both 24 hours (23% vs 1%, respectively; P<0.0001) and 48 hours (13% vs 1%, respectively; P=0.008); and prolonged time to first use of rescue opioid, with median time to rescue medication of 4.2 hours with Exparel vs 0.6 hours with placebo (P<0.0001). Incidence of adverse events (AEs) was comparable between groups, and most AEs were mild to moderate in severity. No clinically significant between-group differences in laboratory values, vital signs, or electrocardiograms were observed. The data, which provided the basis for FDA approval for this indication, were published in Pain Medicine.

See: "Brachial Plexus Block with Liposomal Bupivacaine for Shoulder Surgery Improves Analgesia and Reduces Opioid Consumption: Results from a Multicenter, Randomized, Double-Blind, Controlled Trial." Manish A Patel et al. Pain Medicine, pnz103, https://doi.org/10.1093/pm/pnz103 Published: 31 May 2019