Exparel Receives Pediatric Indication for Post-Surgical Pain Relief

March 22, 2021 – The U.S. FDA has approved an expanded indication for Exparel® (bupivacaine liposome), manufactured by Pacira Pharmaceuticals, to include use in patients who are at least six years old for single-dose infiltration to produce postsurgical local analgesia (pain relief). The product is now the first and only FDA-approved long-acting local analgesic for pediatric patients as young as six. Previously, it was approved for use only in adults.

Opioids are the current standard of care for managing moderate-to-severe pain in pediatric patients but can have serious risks such as respiratory failure and can cause uncomfortable side effects. Exparel contains a local anesthetic that is combined with DepoFoam®, a delivery technology that releases the drug into the body over an extended period following injection.

In a clinical study, Exparel demonstrated similar pharmacokinetic and safety profiles in pediatric patients undergoing spinal or cardiac surgeries as seen in adults treated with the drug. Pharmacokinetics is the study of how a drug travels through, is processed by, and removed from the body.

Recommended pediatric dosing is 4mg/kg of the patient’s body weight, up to a maximum dose of 266mg, administered by a healthcare professional via infiltration. Infiltration is an injection technique designed to produce local pain relief in a specific part of the body.

First FDA approved in 2011, Exparel is also indicated for use as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia in adults.