Exparel is the only FDA-approved single-dose regional analgesic to safely demonstrate four days of superiority versus bupivacaine in two clinical studies —
New indications for use as an adductor canal block and sciatic nerve block in the popliteal fossa will significantly extend reach within more than 3 million lower extremity procedures
TAMPA, Fla., Nov. 10, 2023 (GLOBE NEWSWIRE) — Pacira BioSciences, Inc. (NASDAQ: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental new drug application (sNDA) to expand the Exparel® (bupivacaine liposome injectable suspension) label to include administration in adults as an adductor canal block and a sciatic nerve block in the popliteal fossa.
An adductor canal block is used for anesthesia and analgesia for surgery of the knee, medial lower leg, and ankle surgeries. A sciatic nerve block in the popliteal fossa is used for anesthesia and analgesia for foot, ankle, achilles tendon, and other lower leg surgeries.
“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,” said Dave Stack, chief executive officer and chairman of Pacira BioSciences. “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 3 million lower extremity procedures annually, further increasing the utility of Exparel for major orthopedic procedures.”
The approval is supported by two successful randomized, double-blind, active-controlled, multicenter Phase 3 studies designed to evaluate the efficacy, safety, and pharmacokinetics of Exparel versus bupivacaine HCl. One study evaluated Exparel as a single-dose adductor canal block and the second study evaluated Exparel as a single-dose sciatic nerve block in the popliteal fossa. Both studies met their primary endpoints by demonstrating a statistically significant reduction in cumulative pain scores from 0 to 96 hours compared with bupivacaine HCl (P<0.01).
Additionally, Exparel achieved statistical significance for the studies’ secondary endpoint of reduced postsurgical opioid consumption (P<0.01). Exparel as a sciatic nerve block in the popliteal fossa also achieved statistical significance for the percentage of opioid-free subjects (P<0.01). In both studies, Exparel maintained a safety profile consistent with bupivacaine HCl.
“The addition of these new blocks, coupled with the previously approved interscalene brachial plexus nerve block and the ability to utilize Exparel as a fascial plane block provides clinicians with a wide array of applications to treat postsurgical pain with long-lasting,
Bariatric Endoscopy
9moThis is indeed an ongoing problem. The ubiquitous presence of GLP-1 analogue drugs in the media has led users to forget that there are no long-term results at all, nor whether there might be a metabolic problem over time due to the enormous stimulated insulin secretion (5 times more than normal, even in diabetic compromised ß-cells). In contrast, endoscopic procedures are not very well known in the patient community, but they aren‘t either well known in the doctor community. This is because there is not even a comparable amount of money spent on advertising these procedures compared to drugs.