On Friday the FDA approved a supplemental new drug application (sNDA) for the administration of liposomal bupivacaine (Exparel, Pacira) via interscalene brachial plexus block for postoperative regional analgesia.
Liposomal bupivacaine now becomes the first long-acting, single-dose nerve block available for upper extremity surgeries, such as total shoulder arthroplasty.
The approval comes despite an earlier, marginally negative vote by the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee, which voted on February 15 (6-4 against) to not recommend the sNDA for approval. The fact that liposomal bupivacaine is a non-opioid alternative for post-op pain certainly would have improved the odds for approval.
“Brachial plexus blocks are emerging as a mainstay of postsurgical pain control for upper extremity procedures, and are well positioned to comprise more than 60 percent of all regional nerve block procedures within the next two years, ” Dave Stack, chairman and chief executive officer at Pacira Pharmaceuticals, said in a statement, and added: “We are very gratified to offer clinicians and patients another option for achieving long-lasting non-opioid pain control with [liposomal bupivacaine], and to provide an increased ability to transition procedures commonly thought of as inpatient to the ambulatory setting.”
Liposomal bupivacaine was first approved in 2011 for single-dose infiltration into surgical sites, and has since been used in more than 3.75 million patients, according to Pacira.
“There is a critical need in the postsurgical setting for non-opioid options that turn off pain at the surgical site and reduce the need for opioids,” Jeffrey Gadsden, MD, Chief of Orthopaedics, Plastics, and Regional Anesthesiology and Associate Professor of Anesthesiology at Duke University School of Medicine, said in the Pacira statement.
The sNDA approval was based on positive data from a Phase 3 study of liposomal bupivacaine in brachial plexus block for shoulder surgeries. Liposomal bupivacaine demonstrated statistical significance for the primary endpoint of cumulative pain scores over 48 hours (P<0.0001), and also achieved statistical significance versus placebo for the study’s key secondary endpoints of total postsurgical opioid consumption through 48 hours (P<0.0001); opioid-free subjects through 48 hours (P<0.01); and time to first opioid rescue through 48 hours (P<0.0001).