Pacira BioSciences, Inc. (NASDAQ: PCRX) today announced the publication of its multinational Phase 3 study supporting the efficacy and safety of EXPAREL® (bupivacaine liposome injectable suspension) as a single-injection interscalene brachial plexus nerve block (ISNB) in patients undergoing total shoulder arthroplasty or rotator cuff repair. The results demonstrate that EXPAREL significantly improved pain control and reduced opioid consumption through 48 hours compared with placebo and a standardized pain management protocol alone. The data, which provided the basis for FDA approval for this indication, were published in Pain Medicine.
The study’s primary endpoint was pain intensity scores through 48 hours; secondary endpoints included total postsurgical opioid consumption, percentage of opioid-free patients; and time to first opioid rescue.
A total of 140 patients enrolled across 16 surgical centers in the United States, Belgium, and Denmark were randomized to receive an ultrasound-guided single-dose ISNB with either EXPAREL 133 mg (n=69) or saline placebo (n=71). Compared to patients receiving placebo, patients in the EXPAREL group demonstrated a statistically significant:
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