Positive topline data from phase III study of Exparel as a single dose femoral nerve block in the adductor canal for 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 FDA early next year seeking expansion of the Exparel label to include femoral nerve block in the adductor canal.

“These positive data build on our market-leading position in long-lasting, non-opioid pain control by establishing Exparel as the first and only product with positive Phase III data safely demonstrating four days of superior postsurgical pain relief compared to bupivacaine,” said Dave Stack, chairman and chief executive officer of Pacira BioSciences. “We believe we are now well positioned to broaden the Exparel label with an additional nerve block indication and further solidify the role of Exparel as a cornerstone in opioid-sparing postsurgical pain management regimens that support accelerated recovery and increased case migration to the 23-hour stay environment. This will help us continue to drive paradigm changes in patient care as we redefine the role of opioids as a last resort rescue medication.”

About the Phase III Study: The Phase III, 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 III study for presentation at future scientific conferences and for publication in a peer-reviewed journal.