FDA Approves Expanded Indications for Exparel

The 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.

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