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Exparel achieves primary and key secondary endpoints in phase IV CHOICE study in Cesarean section patients.- Pacira Biosciences Inc.

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Published:8th Jan 2020
Pacira BioSciences, Inc. announced that its Phase IV study of Exparel (bupivacaine liposome injectable suspension) in patients undergoing Cesarean section (C-section) achieved its primary endpoint with a statistically significant reduction in total postsurgical opioid consumption while maintaining pain scores through 72 hours (P less than 0.001). Exparel demonstrated statistical significance for the key secondary endpoint of a reduction in the incidence and severity of itching for 72 hours after surgery (P less than 0.05). Full study results will be submitted for publication in the peer-reviewed medical literature later this year. The Phase IV, multicenter, randomized, active-controlled study across 18 clinical sites in the United States, enrolled 169 patients undergoing elective C-section. Patients were randomized (1:1:1) to receive either 150 mcg morphine spinal anesthesia plus standard of care postoperative pain regimen, 50 mcg morphine spinal anesthesia plus Exparel transversus abdominis plane (TAP) field block or opioid-free spinal anesthesia plus Exparel TAP block. Patients in the Exparel arms received a protocol-defined postoperative pain management regimen comprised of ketorolac, acetaminophen and ibuprofen. All patients could receive opioid rescue pain medicine upon request for breakthrough pain. The company’s previous Phase IV clinical study of Exparel in the C-section setting is awaiting publication in a peer-reviewed medical journal. That study demonstrated the superiority of an Exparel TAP block to a bupivacaine TAP block in patients undergoing C-section, achieving a 52% reduction in opioid use for Exparel-treated patients while also reducing pain scores through 72 hours post-surgery. Importantly, the study demonstrated a statistically significant higher percentage of opioid-spared patients in the Exparel group, with Exparel treated patients taking no more than one opioid tablet and experiencing no opioid-related side effects through 72 hours.
Condition: Pain:Cesarean Section
Type: drug

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