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

– Findings demonstrate significant reduction in pain and opioid consumption through 96 hours versus active comparator –

– Significantly greater proportion of opioid-free patients receiving EXPAREL –

TAMPA, Fla., Feb. 15, 2024 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc., (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today announced the publication of its pivotal Phase 3 study supporting the efficacy and safety of EXPAREL (bupivacaine liposome injectable suspension) as a single-dose sciatic nerve block in the popliteal fossa in patients undergoing bunionectomy. The results demonstrate that EXPAREL significantly improved pain control and reduced opioid consumption through 96 hours versus bupivacaine HCl. The data, which provided the basis for FDA approval for this indication was published in the Journal of Clinical Anesthesia.

“This data provides unequivocal evidence of the safety and efficacy of EXPAREL as the first and only single-dose product to safely provide four days of superior non-opioid pain control compared to bupivacaine HCl,” said Frank D. Lee, Chief Executive Officer of Pacira BioSciences. “Importantly, the use of EXPAREL as a sciatic nerve block in the popliteal fossa affords clinicians additional flexibility in their opioid-sparing pain management approaches for foot and ankle procedures, which continue to migrate to the outpatient environment where success is predicated on the ability to provide appropriate pain control without the need for a significant opioid burden.”

Key findings for EXPAREL 133 mg versus bupivacaine HCl 50 mg administered as a single-dose sciatic nerve block in the popliteal fossa for patients undergoing bunionectomy demonstrated statistically significant and superior pain control over bupivacaine for 4 days post-surgery:

• There was a 44% difference in pain scores through 96 hours—the study’s primary endpoint—as measured by the area under the curve, or AUC, of the Numerical Rating Scale pain intensity scores from 0 to 96 hours post-surgery; P<0.00001
• Patients receiving EXPAREL consumed 61% fewer opioids through 96 hours—the study’s secondary endpoint—LSM total opioid consumption; P<0.00001
• Almost one quarter of patients in the EXPAREL group needed no rescue opioids through 96 hours compared to the bupivacaine group (24.4% vs 6% of patients, respectively)
  • Additionally, patients in the EXPAREL 133 mg arm had approximately five-fold higher odds of being opioid-free compared with the bupivacaine HCl 50 mg arm; P=0.0003

The safety profiles of EXPAREL 133 mg and bupivacaine HCl 50 mg were similar, with a similar proportion of adverse events (AEs) and serious adverse events (SAEs), and all AEs were mild to moderate in severity.