Pacira Announces Publication of Pivotal Study of EXPAREL as a Sciatic Nerve Block in the Popliteal Fossa for Patients After Bunionectomy - Seite 2

“The role of EXPAREL as a sciatic nerve block in the popliteal fossa, particularly for pain control following foot and ankle procedures, is pivotal as clinical goals toward outpatient migration continue to grow,” said Gary Schwartz, MD, FASA, Vice Chair of Pain and Anesthesiology at Maimonides Medical Center and lead author on the publication. “The ability to deliver four days of pain control and reduce reliance on opioids with a single-administration—eliminating the burden of cumbersome catheters and pumps—provides not only a valuable addition to the pain management armamentarium, but also an opportunity to improve patient satisfaction and outcomes for same-day surgical procedures.”

About the Phase 3 Study of EXPAREL as a Sciatic Nerve Block in the Popliteal Fossa
The Phase 3, randomized, double-blind, active-controlled, multicenter study was designed to evaluate the efficacy, safety, and pharmacokinetics of EXPAREL versus bupivacaine HCl administered as a sciatic nerve block in the popliteal fossa. The study was conducted in two parts, with Part A completed and analyzed before enrollment in Part B was initiated.

In total, the study randomized 185 subjects. In Part A, 66 subjects undergoing bunionectomy were randomized 1:1:1 to receive a sciatic nerve block in the popliteal fossa with a single dose of EXPAREL 266 mg, EXPAREL 133 mg or 20 mL 0.25% bupivacaine HCl. In part B, an additional 119 subjects undergoing bunionectomy were randomized 1:1 to receive a sciatic nerve block in the popliteal fossa with a single dose of EXPAREL 133 mg or 20 mL 0.25% bupivacaine HCl. All subjects in Part A and Part B received a Mayo field block with 20 mL 0.5% bupivacaine HCl after study drug administration in the operating room immediately prior to surgical incision. The study’s primary endpoint was the area under the curve, or AUC, of the Numerical Rating Scale pain intensity scores from 0 to 96 hours post-surgery comparing EXPAREL to bupivacaine HCl. Secondary endpoints included total postsurgical opioid consumption from 0 to 96 hours comparing EXPAREL to bupivacaine HCl and percent opioid free from 0-96 hours.

About Pacira BioSciences
Pacira BioSciences, Inc. (Nasdaq: PCRX) is committed to providing a non-opioid option to as many patients as possible to redefine the role of opioids as rescue therapy only. The company is also developing innovative interventions to address debilitating conditions involving the sympathetic nervous system, such as cardiac electrical storm, chronic pain, and spasticity. Pacira has three commercial-stage non-opioid treatments: EXPAREL (bupivacaine liposome injectable suspension), a long-acting, local analgesia currently approved for postsurgical pain management; ZILRETTA (triamcinolone acetonide extended-release injectable suspension), an extended-release, intra-articular, injection indicated for the management of osteoarthritis knee pain; and ioveraº, a novel, handheld device for delivering immediate, long-acting, drug-free pain control using precise, controlled doses of cold temperature to a targeted nerve. To learn more about Pacira, including the corporate mission to reduce overreliance on opioids, visit www.pacira.com.