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Pain and total opioid use are significantly lowered by EXPAREL from 24 to 96 hours, compared to the bupivacaine HCl (p<0,01).
FREMONT, CA: Pacira BioSciences, Inc., the industry leader in its commitment to non-opioid pain management and regenerative health solutions, publish topline results from its Phase 3, randomized, double-blinded, active-controlled, multicenter STRIDE study.
EXPAREL administers as combined sciatic (in popliteal fossa) and saphenous (in adductor canal). Under the curve versus bupivacaine HCl, nerve blocks do not show statistical significance for the study’s primary endpoint of reducing cumulative pain scores from 0 to 96 hours as measured by the area. EXPAREL achieves statistical significance versus bupivacaine HCl for secondary endpoints of reducing cumulative pain scores from 24 to 96 hours post-surgery (p<0.001) and total opioid consumption from 24 to 96 hours post-surgery (p<0.01). EXPAREL also attains statistical significance versus bupivacaine HCl for the area under the curve cumulative pain scores from 12 to 96 hours (p<0.02). The EXPAREL group achieves and maintains mild pain at 36 hours (Least Square Mean NRS 3.0), while bupivacaine HCl is moderate (Least Square Mean NRS 4.7).
There are no clinically relevant safety issues observed in STRIDE, specifically no reports of falls and no serious adverse events observed in the study.
STRIDE offers essential insights into the critical position of EXPAREL as the cornerstone of multimodal protocols to achieve both early-onset and prolonged pain management goals. The company will complete a full analysis of the STRIDE study and plans to discuss these highly informative data and next steps with the U.S. Food and Drug Administration (FDA). Pacira intends to submit the full results from the Phase 3 STRIDE study for presentation at future scientific conferences and publication in a peer-reviewed journal.
“In the absence of preoperative multimodal therapy, the study demonstrated the advantages of EXPAREL versus bupivacaine from 24 hours and beyond. The findings from this study are valuable and demonstrate the ability of an EXPAREL long-acting lower extremity nerve block to provide significant pain relief that extends to 96 hours. These data also add to the significant body of evidence supporting the excellent safety profile of EXPAREL, says Dave Stack, chairman and chief executive officer of Pacira BioSciences. The market is in need of additional approaches to safe and effective opioid-sparing pain management as the surgical suite remains a key gateway to opioid misuse and abuse. We look forward to discussing these important findings with FDA and defining the next steps for broadening the EXPAREL label to include lower extremity nerve blocks.”