Pacira BioSciences' Exparel Misses Primary Endpoint In Post-Op Pain Study After Lower Extremity Surgeries

Pacira BioSciences Inc PCRX has announced topline results from its Phase 3 STRIDE study evaluating Exparel administered as combined sciatic (in popliteal fossa) and saphenous (in adductor canal) nerve blocks in patients after lower extremity surgeries.
The trial did not meet the primary endpoint of statistical significance in pain reduction from 0 to 96 hours for Exparel versus bupivacaine HCl.
Exparel did achieve statistical significance versus bupivacaine HCl for secondary endpoints of reducing cumulative pain scores from 24 to 96 hours post-surgery and total opioid consumption from 24 to 96 hours post-surgery.
The Exparel group achieved and maintained mild pain at 36 hours while bupivacaine HCl was in the moderate range.
There were no clinically relevant safety issues observed in the study, specifically no reports of falls and no serious adverse events observed in the study.
Pacira plans to submit the full results from the study for presentation at future scientific conferences and publication in a peer-reviewed journal.
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