Phase III study of Exparel meets endpoint in bunionectomy surgery
Pacira BioSciences announced positive topline results from its Phase III study of Exparel (bupivacaine liposome injection) 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 (p<0.00001). exparel also achieved statistical significance for reduction in postsurgical opioid consumption (p><0.00001) and percentage of opioid-free subjects (p><0.001) 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 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. Earlier this month, Pacira announced positive results from a Phase III study of Exparel as a single-dose femoral nerve block in the adductor canal for total knee arthroplasty. A sciatic nerve block in the popliteal fossa is used for anesthesia and analgesia for foot, ankle, achilles tendon, and other lower leg surgeries. A femoral nerve block in the adductor canal is used for anesthesia and analgesia for surgery of the knee, medial lower leg, and ankle surgeries. 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.
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