Phase IV study of Exparel shows reduction in opioid use after surgery

Pacira BioSciences announced that full results from its Phase IV study of Exparel (bupivacaine liposome injectable suspension) administered via transversus abdominis plane (TAP) field block in patients undergoing Cesarean section (C-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 51st Annual Meeting of the Society of Obstetric Anesthesia and Perinatology (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 (1:1) 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 (mITT) population who met study protocol criteria regarding proper administration of TAP and multimodal regimen. Key findings include a significant reduction in total opioid consumption with Exparel plus bupivacaine HCl versus bupivacaine HCl, a 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), a 49% reduction at one week (LSM [SE], 23.3 [9.75] vs 45.8 [9.13] mg, respectively; P=0.0175), and a 41% reduction at two weeks (LSM [SE], 28.2 [11.20] vs 47.8 [10.49] mg, respectively; P=0.0542). In addition there was significantly lower cumulative pain scores through 72 hours with Exparel versus bupivacaine HCl, measured using the area under the curve of imputed pain intensity scores collected from 6 to 72 hours (LSM [SE], 147.9 [21.13] vs 178.5 [19.78], respectively; P=0.002), and 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. Finally the 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). Safety was comparable between groups in this study, with 64 percent of patients in the EXPAREL group experiencing a treatment-emergent adverse event (TEAE) versus 56 percent of patients in the bupivacaine HCl group. The most common TEAEs were pruritus (itching) and nausea; serious TEAEs were rare (approximately three percent in both groups).