FDA Expands Exparel Nerve Block for Upper Extremity Procedure Indication

Article

The long-acting, single-dose nerve block can now be used for popularizing procedures such as total shoulder arthroplasty or rotator cuff repair.

fda, exparel, indication, approval

The US Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for expanded indications for bupivacaine liposome injectable suspension (Exparel) that make it the first long-acting, single-dose nerve block for patients undergoing upper extremity surgeries.

The indication broadens Exparel to be administered via interscalene brachial plexus block to produce post-surgical regional anesthesia, allowing its use for total shoulder arthroplasty or rotator cuff repair. It was approved in 2011 for single-dose infiltration into the surgical site, and has been used on nearly 4 million patients in the post-marketing setting since, according to Pacira Pharmaceuticals.

The injectable suspension combines bupivacaine with delivery product DepoFoam, designed to deliver pain-relieving therapy over a desired time period. It is the first and only multi-vesicular liposome local anesthetic designed for use in either the peri- or post-surgical setting.

Exparel’s sNDA indication was backed by positive phase 3 study data which demonstrated its statistical significant in cumulative pain scores over 48 hours of patients undergoing shoulder surgeries through the brachial plexus block. The pain scores, the study’s primary endpoint, were measured by the area under the curve (P < 0.0001).

The study randomized 156 patients in a 1:1 ratio to receive either single-dose Exparel 133 mg in 10 mL expanded in volume (with 10 mL of normal saline for a total volume of 20 mL), or placebo 20 mL. The therapy was administered as a brachial plexus block under ultrasound guidance at least 1 hour prior to patients’ procedures. Participating patients were eligible to receive post-surgical rescue opioids for pain management, upon request.

According to Pacira, Exparel also reached statistical significance versus placebo for total post-surgical 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). Its safety profile was consistent with its previous safety profile in wound infiltration, as well as competitor bupivacaine’s profile when used as a brachial plexus nerve block.

Dave Stack, chairman and chief executive officer at Pacira, said in a statement that brachial plexus blocks are an emerging mainstay of post-surgical pain control, particularly for upper extremity procedures. By his county, they will comprise more than 60% of all regional nerve block procedures within the next 2 years.

“In line with our corporate mission, we are very gratified to offer clinicians and patients another option for achieving long-lasting non-opioid pain control with Exparel, and to provide an increased ability to transition procedures commonly thought of as inpatient to the ambulatory setting,” Stack said.

Jeffrey Gadsden, MD, chief of orthopedic, plastics, and regional anesthesiology at the Duke University School of Medicine, said there is a “critical need” for non-opioid therapies in the post-surgical setting, for pain experienced at the surgical site.

“The ability to provide effective regional analgesia with a single dose of Exparel is a tremendous victory for patients and advances the imperative need for low- or no-opioid pain management strategies,” Gadsden said.

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