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# Pacira Seeking Expanded Label on Exparel
- URL: https://www.fdaweb.com/pacira-seeking-expanded-label-on-exparel/
- Published: 2022-09-07T12:00:00.000Z
- Updated: 2026-09-14T17:58:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152686

Pacira BioSciences says it will submit a supplemental NDA early next year to broaden the label for its post-surgical pain drug Exparel (bupivacaine extended-release liposome injection) for use as a single-dose femoral nerve block in the adductor canal for postsurgical regional analgesia in patients undergoing total knee arthroplasty. The company says the submission will be based on new data from a Phase 3 study showing that Exparel provided a “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.”

Exparel is currently indicated for single-dose infiltration in patients aged six years and older to produce postsurgical local analgesia, and in adults as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia.

The company says Exparel uses the company’s proprietary multivesicular liposomal drug delivery technology “composed of a honeycomb of numerous, non-concentric, internal aqueous chambers containing bupivacaine. After injection, bupivacaine is released over time, as the lipid membranes are absorbed, prolonging the duration of action.”