Pacira announces Phase 4 Exparel study achieves primary endpoint.
Pacira announced that its Phase 4 study of Exparel in patients undergoing Cesarean section 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 full study results will be submitted for publication in the peer-reviewed medical literature later this year. Importantly, the study also achieved statistical significance for relevant additional endpoints pre-specified in the statistical analysis plan to better characterize the clinical benefit of the opioid reduction, including: total opioid consumption at one and two weeks following C-section and percentage of opioid-spared patients, a composite endpoint, which was defined as patients who took no more than one oxycodone 10 mg tablet and graded their bother or stress from the following opioid-related adverse events as "not at all": vomiting, itching, sweating, freezing, or dizziness. This was a multicenter, randomized, double-blind study including a total of 13 sites and 186 patients. Patients undergoing elective C-section and given spinal anesthesia were randomized to receive Exparel or the active comparator bupivacaine HCl. Patients in the Exparel arm were administered a transversus abdominis plane field block with 10 mL Exparel admixed with 10 mL 0.25% bupivacaine HCl and 10 mL normal sterile saline injected bilaterally. Patients in the active comparator arm received a TAP field block with 10 mL 0.25% bupivacaine HCl admixed with 20 mL normal sterile saline injected bilaterally. In accordance with current medical practice, prior to C-section all patients in this study received an intrathecal injection of 150 mcg preservative-free morphine for spinal injection in conjunction with single-shot spinal anesthesia using 1.4-1.6 mL bupivacaine HCl 0.75% and 15 mcg fentanyl. Following C-section, patients also received 15 mg of intravenous ketorolac, 1000 mg of IV acetaminophen at the time of skin incision closure, and oral acetaminophen and ibuprofen beginning 6 hours after skin incision closure for up to 72 hours following surgery. Rescue medication was available upon request and postsurgical opioid consumption through 72 hours was collected. Pain intensity was measured using visual analog scale pain intensity scores at rest from 6 to 72 hours. As a follow-on to this study, Pacira will soon begin enrollment in CHOICE, its C-section trial designed to be completely opioid-free in the Exparel arm, including opioid-free spinal anesthesia.