FDA approves expanded use of long-acting local analgesic for children

The FDA has approved a supplemental new drug application for the long-acting local analgesic Exparel for use in children aged 6 years or older “for single-dose infiltration to produce postsurgical local analgesia,” Pacira said.

The decision makes Exparel (bupivacaine liposome injectable suspension) the only FDA-approved long-acting local analgesic for pediatric populations as young as 6 years, Pacira said.

“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,” Pacira CEO Dave Stack said in a news release. “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 nonopioid pain control in children without the need for an indwelling catheter and pump.”

Since its initial approval in 2011, more than 8 million people have been treated with Exparel, according to the company, which said that approximately 1 million pediatric procedures per year include the use of opioids, catheters and pain pumps for postsurgical pain control.

“There has been a significant gap in our pain control armamentarium as it relates to the ability to safely and effectively provide long-lasting nonopioid pain control for the pediatric surgical population,” Christopher Tirotta, MD, chief anesthesiologist at Nicklaus Children’s Hospital in Miami, said in the news release.

Pacira’s supplemental new drug application was based on data from a phase 3 study conducted in pediatric patients who underwent spinal or cardiac surgery.