Phase III PLAY study of Exparel shows safety in pediatric post-surgical pain treatment.- Pacira BioSciences

Pacira BioSciences announced positive results from its Phase III PLAY study of Exparel (bupivacaine liposome injectable suspension) administered as a single-dose 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. These results will provide the foundation for the company�s supplemental New Drug Application submission in the first half of 2020 to the FDA seeking expansion of the Exparel label to include children aged six and over.

The Company�s pediatric program has been designed in consultation with FDA with a second Phase III registration study of Exparel administered as a nerve block in the pediatric setting expected to initiate in 2020. 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. Exparel is the only non-opioid, single-dose, long-acting local analgesic that is FDA-approved for infiltration, field block and brachial plexus nerve block. The Exparel formulation allows for expansion with saline for larger procedures, as well as admixture with bupivacaine so that pain management can be tailored to the patient�s needs across a broad range of small and large procedures. More than 6 million patients have received Exparel since its launch in 2012.