The approval was based on the results from two successful randomised, double-blind, active-controlled, multicentre Phase 3 trials which met primary endpoints and secondary endpoints
FDA has approved Exparel for two new indications. (Credit: Nappy on Unsplash)
Pacira BioSciences said that the US Food and Drug Administration (FDA) has approved its supplemental new drug application (sNDA) to expand the Exparel (bupivacaine liposome injectable suspension) label to include two new nerve block indications.
The FDA has approved Exparel to include administration in adults as an adductor canal block and a sciatic nerve block in the popliteal fossa.
Exparel is designed to produce postsurgical local analgesia through infiltration in patients of age six or more.
It is also intended for postsurgical regional analgesia via an interscalene brachial plexus block in adults, a sciatic nerve block in the popliteal fossa in adults, and an adductor canal block in adults.
Pacira BioSciences CEO and chairman Dave Stack said: “We are thrilled that today’s approval offers clinicians and patients another option for achieving long-lasting non-opioid pain control with Exparel and an increased ability to transition procedures to the ambulatory environment.
“In line with our corporate mission to provide a non-opioid to as many patients as possible, this new indication provides additional flexibility in the use of Exparel as a regional analgesic for more than three million lower extremity procedures annually, further increasing the utility of Exparel for major orthopaedic procedures.”
The approval from the US health regulator was based on the results from two successful randomised, double-blind, active-controlled, multicenter Phase 3 trials.
Both studies were intended to assess the safety, efficacy, and pharmacokinetics of Exparel against bupivacaine HCl.
The drug was assessed as a single-dose sciatic nerve block in the popliteal fossa in one study and as a single-dose adductor canal block in another.
When compared to bupivacaine HCl, both trials showed a statistically significant decrease in cumulative pain scores from 0 to 96 hours, meeting their primary endpoints.
Additionally, Exparel reached statistical significance for the secondary endpoint of the study, which was defined as the reduced opioid intake following surgery.
Furthermore, it maintained the same safety profile as bupivacaine HCl in both trials.