Pacira Secures FDA Approval for Extended EXPAREL Label, Introducing Two Additional Nerve Block Indications
Saturday, November 11, 2023
Pacira BioSciences, Inc. (NASDAQ: PCRX) has received approval from the U.S. Food and Drug Administration (FDA) for its supplemental new drug application (sNDA) to expand the label of EXPAREL® (bupivacaine liposome injectable suspension). The expansion includes the administration of EXPAREL in adults as an adductor canal block and a sciatic nerve block in the popliteal fossa.
The adductor canal block is utilized for anesthesia and analgesia during knee, medial lower leg, and ankle surgeries. On the other hand, the sciatic nerve block in the popliteal fossa is employed for anesthesia and analgesia in foot, ankle, Achilles tendon, and other lower leg surgeries.
Pacira BioSciences, expressed enthusiasm about the approval, stating that it provides clinicians and patients with another option for long-lasting non-opioid pain control with EXPAREL. He highlighted the company's commitment to offering non-opioid solutions to a broader patient population, emphasizing the increased flexibility in using EXPAREL for over 3 million lower extremity procedures annually, particularly in major orthopedic procedures.
The approval is based on two successful Phase 3 studies that assessed the efficacy, safety, and pharmacokinetics of EXPAREL versus bupivacaine HCl. One study focused on EXPAREL as a single-dose adductor canal block, while the other evaluated it as a single-dose sciatic nerve block in the popliteal fossa. Both studies demonstrated a statistically significant reduction in cumulative pain scores and a decrease in postsurgical opioid consumption with EXPAREL compared to bupivacaine HCl.
Dr. Jeffrey Gadsden, Chief of Orthopaedic, Plastic, and Regional Anesthesiology at Duke University School of Medicine, emphasized the significance of these new blocks alongside previously approved applications, offering a broad range of options for treating postsurgical pain with long-lasting, non-opioid analgesia through a single-dose administration.
These advancements align with the growing preference among clinicians and patients to avoid opioids and achieve same-day discharge when appropriate, contributing to enhanced recovery protocols. The full results from the Phase 3 studies are expected to be published in a peer-reviewed journal.
Source: globenewswire.com
