Pacira BioSciences IncPCRX announced topline results from its Phase 3 study of EXPAREL as a single-dose sciatic nerve block in the popliteal fossa for postsurgical regional analgesia in patients undergoing bunionectomy, correcting the deformity of the bones making up the toe and foot.
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.
EXPAREL also achieved statistical significance for the reduction in postsurgical opioid consumption and percentage of opioid-free subjects 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 to expand the EXPAREL label to include sciatic nerve blocks in the popliteal fossa, as well as femoral nerve blocks in the adductor canal.
Price Action: PCRX shares are up 3.03% at $56.70 on the last check Wednesday.
