FDA Approves Exparel Label Expansion to Include 2 New Nerve Block Indications

Originally published by our sister publication Anesthesiology News

The FDA has approved a supplemental New Drug Application to expand the label of bupivacaine liposome injectable suspension (Exparel, Pacira BioSciences) to include administration in adults as an adductor canal block and a sciatic nerve block in the popliteal fossa.

According to the company, 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 the drug for major orthopedic procedures, including those in the knee, lower leg, foot, ankle and Achilles tendon.

Findings from two successful randomized, double-blind, active-controlled, multicenter, phase 3 studies support the expanded approval. The studies were designed to evaluate the efficacy, safety and pharmacokinetics of bupivacaine liposome injectable suspension compared with bupivacaine hydrochloride (HCl). One study evaluated bupivacaine liposome injectable suspension as a single-dose adductor canal block.

The study enrolled 166 participants who were randomized 1:1 to receive either 10 mL (133 mg) of bupivacaine liposome injectable suspension admixed with 10 mL of 0.5% bupivacaine HCl or 10 mL of 0.5% bupivacaine HCl mixed with 10 mL of normal saline. Through an infiltration between the popliteal artery and capsule of the knee (iPACK) block, all participants received 15 mL of 0.25% bupivacaine HCl.

The other study sought to determine the efficacy of the drug as a single-dose sciatic nerve block in the popliteal fossa and was performed in two parts. A total number of 185 patients were evaluated. In part A, 66 patients undergoing bunionectomy were randomized 1:1:1 to receive a sciatic nerve block in the popliteal fossa with a single dose of bupivacaine liposome injectable suspension 266 mg, bupivacaine liposome injectable suspension 133 mg or 20 mL of 0.25% bupivacaine HCl. An additional 119 bunionectomy patients were evaluated in part B and randomized 1:1 to receive a sciatic nerve block in the popliteal fossa with a single dose of bupivacaine liposome injectable suspension 133 mg or 20 mL of 0.25% bupivacaine HCl. After study drug administration in the OR immediately before surgical incision, patients received a Mayo field block with 20 mL of 0.5% bupivacaine HCl in both parts of the study.

By demonstrating a statistically significant reduction in cumulative pain scores from 0 to 96 hours compared with bupivacaine HCl (P<0.01), both studies met their primary end points.

The studies also achieved their secondary end points of reduced postsurgical opioid consumption (P<0.01). As a sciatic nerve block in the popliteal fossa, bupivacaine liposome injectable suspension additionally achieved statistical significance for the percentage of opioid-free patients (P<0.01). Both studies showed that bupivacaine liposome injectable suspension 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, nonopioid analgesia via a single dose administration,” said Jeffrey Gadsden, MD, the chief of orthopedic, plastic and regional anesthesiology, and a professor of anesthesiology at Duke University School of Medicine, in Durham, N.C. “Enhanced recovery protocols built around Exparel regional and fascial plane blocks continue to play a critical—and expanding—role in achieving increased clinician and patient preference to avoid opioids and achieve same-day discharge when appropriate.”

By AN Staff

Based on company materials.