FDA approves supplemental NDA for Exparel for postsurgical local analgesia in pediatric patients – Pacira BioSciences
Pacira BioSciences, Inc. announced the FDA has approved the submission of its supplemental new drug application (sNDA) seeking expansion of the Exparel label to include use in patients 6 years of age and older for single-dose infiltration to produce postsurgical local analgesia.
With this approval, Exparel is the first and only FDA approved long-acting local analgesic for the pediatric population as young as age six.
“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 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.”
Since initial approval in 2011, more than 8 million patients have been treated with Exparel. With approximately one million pediatric procedures per year where opioids, catheters and pain pumps are the mainstay of postsurgical pain control, there is an urgent unmet need for opioid alternatives.