Pacira BioSciences Announces FDA Acceptance of sNDA for EXPAREL Use in Pediatric Patients

Pacira BioSciences announced the U.S. Food and Drug Administration (FDA) has accepted the submission of its supplemental new drug application (sNDA) seeking expansion of the EXPAREL® (bupivacaine liposome injectable suspension) label to include single-dose infiltration to provide postsurgical analgesia in children aged six and over. The expected action date by the FDA under the Prescription Drug User Fee Act (PDUFA) is March 22, 2021.

The sNDA is based on the positive data from the Phase 3 PLAY study of EXPAREL infiltration in pediatric patients undergoing spinal or cardiac surgeries. Overall findings were consistent with the pharmacokinetic and safety profiles for adult patients with no safety concerns identified at a dose of 4 mg/kg.

“The FDA acceptance of our sNDA submission confirms and reinforces our unwavering dedication to provide opioid alternatives to as many patients as possible,” said Donald Manning, MD, PhD, chief medical officer at Pacira. “Currently, postsurgical moderate and severe pain in pediatric patients is principally managed with opioids, which we know come with unwanted and potentially life-threatening side effects. Expanding the EXPAREL label to the pediatric population will positively impact children, parents, clinicians, hospitals, and payers -- as there is a critical need for non-opioid options in this vulnerable population.”

The PLAY study enrolled 98 patients to evaluate the pharmacokinetics and safety of EXPAREL for two patient groups: patients aged 12 to less than 17 years and patients aged 6 to less than 12 years. Per FDA guidance, the primary objectives of the PLAY study were to evaluate the pharmacokinetics and safety of EXPAREL. The full study results will be submitted for publication in the peer-reviewed medical literature later this year.

The company’s pediatric program was designed in consultation with the FDA. EXPAREL is the only non-opioid, single-dose, long-acting local anesthetic that is FDA-approved for infiltration, field block and interscalene brachial plexus nerve block in patients 18 years of age and older. More than 7 million patients have received EXPAREL since its launch in 2012. If approved, EXPAREL will be the only long-acting local anesthetic approved for use in children.