Pacira announces full results from Phase 4 Exparel study
Pacira announced that full results from its Phase 4 study of Exparel administered via transversus abdominis plane, or TAP, field block in patients undergoing Cesarean section. 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 pain intensity scores through 72 hours. The data were presented from the podium at the Society of Obstetric Anesthesia and Perinatology, or SOAP. This was a multicenter, randomized, double-blind study across 13 clinical sites in the United States, enrolling 186 patients undergoing elective C-section and receiving spinal anesthesia. Patients were randomized to receive Exparel 266 mg plus bupivacaine HCl 50 mg or bupivacaine HCl 50 mg alone administered via TAP field block after surgery. Efficacy was evaluated in a pre-specified modified intent-to-treat, or mITT, population who met study protocol criteria regarding proper administration of TAP and multimodal regimen. The study found significant reduction in total opioid consumption with Exparel plus bupivacaine HCl versus bupivacaine HCl, lower cumulative pain scores through 72 hours with Exparel versus bupivacaine HCl and higher percentage of opioid-spared patients with Exparel versus bupivacaine HCl. Safety was comparable between groups in this study, with 64% of patients in the Exparel group experiencing a treatment-emergent adverse event, or TEAE, versus 56% of patients in the bupivacaine HCl group. The most common TEAEs were pruritus and nausea; serious TEAEs were rare. There were no fatal TEAEs.