PCRX - Pacira meets key goal in late-stage trial to expand label for local anesthetic

Pacira BioSciences ( NASDAQ: PCRX ), a company focused on non-opioid pain management, announced Wednesday that leading therapy Exparel reached the primary endpoint in a Phase 3 trial allowing the company to seek label expansion for the local anesthetic.

The randomized trial was designed to evaluate Exparel versus bupivacaine HCl administered as a femoral nerve block in the adductor canal for postsurgical regional analgesia in patients undergoing total knee arthroplasty.

The multicenter trial involved 166 subjects who were randomized 1:1 to receive either Exparel admixed with local anesthetic bupivacaine HCl or bupivacaine HCl mixed with normal saline.

Topline data indicate that Exparel reached the study’s primary endpoint showing a statistically significant decline in total pain scores from 0 to 96 hours compared to bupivacaine HCl.

The trial also achieved a key secondary endpoint demonstrating a statistically significant decline in postsurgical opioid consumption through 96 hours compared with bupivacaine HCl.

“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….” PCRX Chief Executive Dave Stack remarked.

PCRX expects to submit a supplemental New Drug Application to the FDA early next year, seeking a label expansion for Exparel to include the new indication.  The company has yet to submit the data for publication in a peer-reviewed journal.

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