Research & Development
Pacira BioSciences receives FDA approval for EXPAREL label expansion
10 November 2023 -

Pacira BioSciences Inc (NASDAQ:PCRX), a provider of non-opioid pain management and regenerative health solutions, said on Friday that it has secured US Food and Drug Administration (FDA) approval for an expanded label for EXPAREL (bupivacaine liposome injectable suspension).

This approval includes two new indications for use in adults: as an adductor canal block and a sciatic nerve block in the popliteal fossa.

The expanded label positions EXPAREL as the sole FDA-approved single-dose regional analgesic demonstrating four days of superiority over bupivacaine in clinical studies. These new indications are expected to significantly broaden EXPAREL's application scope within more than 3 million lower extremity procedures.

An adductor canal block is used for knee, medial lower leg and ankle surgeries, while a sciatic nerve block in the popliteal fossa is employed for foot, ankle, achilles tendon and other lower leg surgeries. The FDA approval is based on the success of two Phase 3 studies, which showed EXPAREL's efficacy, safety and pharmacokinetics in comparison to bupivacaine HCl. Notably, EXPAREL demonstrated statistically significant reductions in cumulative pain scores and postsurgical opioid consumption, maintaining a safety profile consistent with bupivacaine HCl.