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Pacira Announces Publication of Phase 4 Study of EXPAREL in Cesarean Section Procedures in Anesthesia & Analgesia
– Results show an opioid-reducing benefit of adding EXPAREL to bupivacaine transversus abdominis plane (TAP) blocks for cesarean delivery – PARSIPPANY, N.J.,
About this update from Pacira Biosciences, Inc.
[{"type":"text","content":"– Results show an opioid-reducing benefit of adding EXPAREL to bupivacaine transversus abdominis plane (TAP) blocks for cesarean delivery –\n PARSIPPANY, N.J., Aug. 05, 2020 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ: PCRX) today announced that full results its Phase 4 study of EXPAREL® (bupivacaine liposome injectable suspension) administered via transversus abdominis plane (TAP) field block in patients undergoing Cesarean section (C-section) have been published in Anesthesia and Analgesia. In this study, EXPAREL achieved its primary endpoint with a statistically significant reduction in total postsurgical opioid consumption through 72 hours. EXPAREL also achieved statistical significance for reduction in percentage of opioid-spared patients through 72 hours. This was a multicenter, randomized, double-blind study across 13 clinical sites in the United States, in patients undergoing elective C-section and receiving spinal anesthesia and a multimodal analgesic regimen. Patients were randomized (1:1) to receive EXPAREL 266 mg plus bupivacaine HCl 50 mg or bupivacaine HCl 50 mg alone administered via TAP field block after delivery. Effectiveness was evaluated in a pre-specified modified intent-to-treat (mITT) population which met the study criteria regarding proper administration of TAP and multimodal regimen (N=136). Key findings include: Significant reduction in total opioid consumption with EXPAREL plus bupivacaine HCl versus bupivacaine HCl 52% reduction through 72 hours, the primary endpoint of the study (least squares mean [LSM] standard error [SE], 15.5 [6.67] vs 32.0 [6.25] mg, respectively; P=0.0117)49% reduction at one week (LSM [SE], 23.3 [9.75] vs 45.8 [9.13] mg, respectively; P=0.0175) 41% reduction of opioid consumption at two weeks, although results did not reach statistical significance (LSM [SE], 28.2 [11.20] vs 47.8 [10.49] mg, respectively; P=0.0542)Significantly higher percentage of opioid-spared patients with EXPAREL versus bupivacaine HCl, defined as patients who took no more than one oxycodone 10 mg tablet (or equivalent) with no opioid-related side effects through 72 hours Percentage of opioid-spared patients was 2.2 times higher in the EXPAREL group vs bupivacaine HCl group (54% vs 25%, respectively; P=0.0012) Optimized pain control through 72 hours, which was comparable in both groups Patients in...