FDA Approved sNDA for Postsurgical Local Analgesia Bupivacaine Liposome Injectable Suspension in Pediatric Patients

The FDA has approved the submission of a supplemental new drug application (sNDA) that expands the use of bupivacaine liposome injectable suspension (Exparel, Pacira BioSciences) to include patients aged 6 years and older for single-dose infiltration as a postsurgical local analgesia.

Following the approval of the sNDA, bupivacaine liposome injectable suspension is currently the first and only long-acting local analgesic approved by the FDA for use in pediatric patients as young as 6 years of age.

“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,” said Dave Stack, chairman and chief executive officer at Pacira, in a press release. “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.”

In 2011, bupivacaine liposome injectable suspension was initially approved by the FDA for use in an adult population. Since that time, more than 8 million adult patients have been treated with the drug following surgery, according to a Pacira BioSciences press release.

Prior to the approval of this sNDA, no postsurgical local analgesia was approved for use in a pediatric population, resulting in the use of opioids, catheters, and pain pumps as the mainstay of postsurgical pain control for these patients. With approximately 1 million pediatric procedures per year, there is a clear need for alternatives to opioids for pain management in children following surgery.

“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 study investigator Christopher Tirotta, MD, chief of anesthesiology at Nicklaus Children's Hospital, in the press release. “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 FDA based the sNDA approval on their review of the positive data from the phase 3 PLAY study investigating the safety and pharmacokinetics of bupivacaine liposome injectable suspension infiltration in pediatric patients who had undergone spinal or cardiac surgeries. The study investigators enrolled 98 pediatric patients and separated them into 2 groups based on age. One group contained patients aged 12 to less than 17 years, and the other group contained patients aged 6 to less than 12 years.

The primary objectives of evaluating both pharmacokinetics and safety during the PLAY study were established based on guidance by the FDA. Overall, the study results demonstrated that both the pharmacokinetic and safety profiles of bupivacaine liposome injectable suspension were consistent with that of the adult patients. Additionally, no safety concerns were identified at a dose of 4 mg/kg in both pediatric population groups studied.

“Moderate-to-severe postsurgical pain is experienced by 40% of hospitalized children, and every scoliosis patient I treat surgically. Over and under treated pain in pediatric patients is a significant cause of morbidity after surgery,” said Peter Newton, MD, chief of the Division of Orthopedics & Scoliosis at Rady Children's Hospital-San Diego and Clinical Professor at UC San Diego School of Medicine, in a press release. “Opioids are responsible for 50% of postsurgical respiratory failure events in children, and often cause unpleasant side effects delaying a patient’s recovery after surgery. This FDA approval is a remarkable victory for pediatric patients and their families and paves the way for opioid-minimizing pain management protocols in children undergoing surgery.”

REFERENCE

Pacira Announces FDA Approval of Supplemental New Drug Application for EXPAREL® (bupivacaine liposome injectable suspension) in Pediatric Patients. Parsippany, NJ: Pacira BioSciences; March 22, 2021. [email] Accessed March 24, 2021.