FDA Approves Bupivacaine Liposome Injectable for Pediatric Surgeries

The label expansion is for patients aged 6 years and older.

The US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for bupivacaine liposome injectable suspension (EXPAREL) treatment for pediatric patients as a single-dose infiltration to produce post-surgical local analgesia.

The approval will allow Pacira BioSciences to move forward with the expansion of the existing label for patients 6 years old and older.

“The current standard of care for managing moderate-to-severe pain in children is opioids, which often come with unwanted severe and possibly life-threatening side effects in this vulnerable patient population,” Dave Stack, Chairman and Chief Executive Officer at Pacira, said in a statement. “In line with our corporate mission to provide an opioid alternative to as many patients as possible, we are grateful for the opportunity to give clinicians and patients a new, safe and effective option for achieving long-lasting non-opioid pain control in children without the need for an indwelling catheter and pump.”

The Study

The approval is based on the phase 3 PLAY study for 98 pediatric patients undergoing spinal or cardiac surgeries. The findings were consistent with the pharmacokinetic and safety profiles found using the treatment for adult patients with no safety concerns identified at a dose of 4 mg/kg.

“There has been a significant gap in our pain control armamentarium as it relates to the ability to safely and effectively provide long-lasting non-opioid pain control for the pediatric surgical population,” said Christopher Tirotta, MD, Chief of Anesthesiology at Nicklaus Children's Hospital and an investigator in the pivotal PLAY study, in a statement. “Traditional local anesthetics have not provided a duration of pain control that matches the time course of the most significant postsurgical pain, which has necessitated the reliance on opioids in an attempt to manage pain. With the addition of EXPAREL as an FDA-approved non-opioid option to provide prolonged pain control we are better equipped to treat our pediatric patients while reducing opioid exposure, and ultimately improving outcomes.”

The Treatment

The treatment was initially approved in 2011 and has been used in over 8 million patients since 2012.

Approximately 40% of hospitalized children experience moderate-to-severe postsurgical pain, while opioids are responsible for half of postsurgical respiratory failure events for this patient group.