Pacira Posts Topline Data From Knee Surgery Study With Its Flagship Pain Management Drug

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  • Pacira BioSciences Inc PCRX 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.
  • Price Action: PCRX shares are up 0.35% at $51.42 on the last check Wednesday.
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