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