Pacira Posts Topline Data From Knee Surgery Study With Its Flagship Pain Management Drug
- Pacira BioSciences Inc announced topline results from its Phase 3 study of EXPAREL as a single-dose femoral nerve block in the adductor canal for postsurgical regional analgesia in patients undergoing total knee arthroplasty.
- EXPAREL achieved the study's primary endpoint demonstrating a statistically significant reduction in cumulative pain scores from 0 to 96 hours compared with bupivacaine HCl.
- EXPAREL also achieved a statistically significant reduction in postsurgical opioid consumption through 96 hours compared with bupivacaine HCl.
- EXPAREL was well tolerated with a safety profile consistent with bupivacaine HCl.
- Pacira plans to submit a supplemental marketing application to the FDA early next year seeking expansion of the EXPAREL label to include femoral nerve block in the adductor canal.
- The company plans to submit the full results from the Phase 3 study for presentation at future scientific conferences and publication in a peer-reviewed journal.
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