The US Food and Drug Administration (FDA) has approved the changes to the Exparel packaging and label proposed by the Pacira Pharmaceuticals, Inc. as part of a routine label supplement application, submitted on November 27, 2013. The approved label changes are limited to revisions pertaining to the product’s storage, instructions of use and use in special populations, and do not impact its indication.
“We’re pleased to announce routine, but important updates to our label and look forward to continuing discussions with the FDA as we approach the March 2015 PDUFA date for our supplemental new drug application for a nerve block indication,” said Dave Stack, CEO of Pacira.
Exparel is indicated for single-dose administration into the surgical site to produce postsurgical analgesia. Pacira has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for a nerve block indication for Exparel, with a target Prescription Drug User Fee Act (PDUFA) date of March 5, 2015.
Exparel (bupivacaine liposome injectable suspension) is indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia. The product combines bupivacaine with DepoFoam, a proven product delivery technology that delivers medication over a desired time period. Exparel represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting in the same fashion as current local anesthetics. By utilizing the DepoFoam platform, a single dose of Exparel delivers bupivacaine over time, providing significant reductions in cumulative pain scores with a 45% decrease in opioid consumption; the clinical benefit of the opioid reduction was not demonstrated.
Pacira Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the clinical and commercial development of new products that meet the needs of acute care practitioners and their patients.