Pacira BioSciences Reports Positive Topline Data From Phase 3 Study Of EXPAREL
(RTTNews) - Pacira BioSciences, Inc. (PCRX) announced Wednesday positive topline results from its Phase 3 study of EXPAREL as a single-dose sciatic nerve block in the popliteal fossa for postsurgical regional analgesia in patients undergoing bunionectomy.
EXPAREL achieved the study's primary endpoint by demonstrating a statistically significant reduction in cumulative pain scores from 0 to 96 hours compared with bupivacaine HCl.
EXPAREL also achieved statistical significance for reduction in postsurgical opioid consumption and percentage of opioid-free subjects through 96 hours compared with bupivacaine HCl, which were key secondary endpoints. EXPAREL was well tolerated with a safety profile consistent with bupivacaine HCl.
Pacira plans to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) early next year to expand the EXPAREL label to include sciatic nerve blocks in the popliteal fossa, as well as femoral nerve blocks in the adductor canal.
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