FDA Expands Indication of Regional Analgesic to Reduce Postsurgical Pain Without Opioids

The FDA approved a new indication for bupivacaine liposome injectable suspension (Exparel; Pacira BioSciences), according to a press release. The approved supplemental new drug application (sNDA) allows for the administration of the single-dose regional analgesic as an adductor canal block and sciatic nerve block in the popliteal fossa.¹

“This new indication provides additional flexibility in the use of [bupivacaine liposome injectable suspension] as a regional analgesic for more than 3 million lower extremity procedures annually, further increasing the utility of [bupivacaine liposome injectable suspension] for major orthopedic procedures,” said Dave Stack, chief executive officer and chairman of Pacira BioSciences, in the press release.¹

Adductor canal blocks are used as anesthesia and analgesia for surgeries of the knee, medial lower leg, or ankle. When administered as a sciatic nerve block in the popliteal fossa (the “pit” behind the knee joint), it functions as an anesthetic or analgesic for patients who are undergoing surgery of the foot, ankle, Achilles tendon, or lower leg.²

Investigators conducted 2 randomized and controlled trials to evaluate the efficacy, safety, and pharmacokinetics of bupivacaine liposome injectable suspension against bupivacaine HCL (Bupivacaine; Pfizer). In both studies, bupivacaine liposome injectable suspension statistically and significantly reduced the patients’ cumulative pain scores (based on responses to Numerical Rating Scale pain intensity scores) from baseline to 96 hours compared with bupivacaine HCl (P<0.01).¹

“The addition of these new blocks… provides clinicians with a wide array of applications to treat postsurgical pain with long-lasting, non-opioid analgesia via a single-dose administration,” said Jeffrey Gadsden, MD, chief of orthopedic, plastic, and regional anesthesiology and professor of anesthesiology at Duke University School of Medicine, in the press release.¹

In trial 1, investigators compared bupivacaine liposome injectable suspension to bupivacaine HCL as an adductor canal block in 166 patients. Patients were randomized 1:1 to receive either 10 mL (133 mg) of bupivacaine liposome injectable suspension combined with 10 mL 0.5% bupivacaine HCl or 10 mL bupivacaine HCl (0.5%) combined with 10 mL normal saline.¹

Trial 2 was a 2-part study comparing bupivacaine liposome injectable suspension to bupivacaine HCL as a sciatic nerve block in the popliteal fossa. During part A, 66 patients were randomized 1:1:1 to receive single-dose bupivacaine liposome injectable suspension in doses 266 mg or 133 mg, or 20 mL bupivacaine HCl (0.25%). In part B, 119 different patients received a single-dose of bupivacaine liposome injectable suspension (133 mg) or 20 mL bupivacaine HCl (0.25%).¹

The most common adverse events (AEs) reported from patients who received wound injection include nausea, constipation, and vomiting. Among patients who received injection near a nerve, the most common AEs were nausea, fever, and constipation. Children have been reported to experience nausea, vomiting, constipation, low blood pressure, low red blood cell count, muscle twitching, blurred vision, itching, and rapid heartbeat.¹

Bupivacaine liposome injectable suspension has been previously approved as a postsurgical local analgesia via infiltration for patients aged 6 years and older, and postsurgical regional analgesia via an interscalene brachial plexus block in adults. It is currently the only multivesicular liposome local anesthetic indicated in the peri- or postsurgical setting. According to Pacira, the medication can be delivered over a long time, and it significantly reduced pain and opioid consumption at 78%.¹

“We are thrilled that today’s approval offers clinicians and patients another option for achieving long-lasting non-opioid pain control with [bupivacaine liposome injectable suspension] and an increased ability to transition procedures to the ambulatory environment,” Stack said in the press release.¹

Reference

1. Pacira Announces FDA Approval of Expanded Exparel Label to Include Two Additional Nerve Block Indications. Pacira. News Release. November 10, 2023. Accessed on November 10, 2023. https://investor.pacira.com/news-releases/news-release-details/pacira-announces-fda-approval-expanded-exparel-label-include-two
2. Hyland S, Sinkler MA, Varacallo M. Anatomy, Bony Pelvis and Lower Limb: Popliteal Region. StatPearls. StatPearls Publishing. 2023. https://www.ncbi.nlm.nih.gov/books/NBK532891/