Pacira BioSciences, Inc. announced positive 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 (p<0.01). EXPAREL also achieved a statistically significant reduction in postsurgical opioid consumption through 96 hours (p<0.01) compared with bupivacaine HCl, a key secondary endpoint.

EXPAREL was well tolerated with a safety profile consistent with bupivacaine HCl. With these positive results, Pacira plans to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration early next year seeking expansion of the EXPAREL label to include femoral nerve block in the adductor canal. About the Phase 3 Study: The Phase 3, randomized, double-blind, multicenter, active-controlled study was designed to evaluate the efficacy, safety, and pharmacokinetics of EXPAREL admixed with bupivacaine HCl versus bupivacaine HCl administered as a femoral nerve block in the adductor canal block for postsurgical analgesia in subjects undergoing primary unilateral total knee arthroplasty. In total, 166 subjects were randomized 1:1 to receive either 10 mL (133 mg) of EXPAREL admixed with 10 mL (50 mg) 0.5% bupivacaine HCl or 10 mL (50 mg) 0.5% of bupivacaine HCl mixed with 10 mL normal saline.

The study's primary endpoint was the area under the curve, or AUC, of the Numerical Rating Scale pain intensity scores from 0 to 96 hours post-surgery comparing EXPAREL to 0.5% bupivacaine HCl. Secondary endpoints included total postsurgical opioid consumption from 0 to 96 hours comparing EXPAREL to bupivacaine HCl. Pacira plans to submit the full results from the Phase 3 study for presentation at future scientific conferences and for publication in a peer-reviewed journal.