Pacira Pharmaceuticals, Inc. Announces EXPAREL Achieves Statistically Significant Reductions in Opioid Consumption and Pain Scores in Cesarean Section Patients
January 16, 2019 at 07:30 am
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Pacira Pharmaceuticals, Inc. announced that its Phase 4 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 through 72 hours (P=0.05). EXPAREL also achieved statistical significance for reduction in pain intensity scores through 72 hours (P=0.05). The full study results will be submitted for publication in the peer-reviewed medical literature later 2019. Importantly, the study also achieved statistical significance (P=0.05) 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, Percentage of opioid-spared patients, a composite endpoint, which was defined as patients who took no more than one oxycodone 10 mg tablet (or equivalent) 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 (TAP) field block with 10 mL EXPAREL admixed with 10 mL 0.25% bupivacaine HCl and 10 mL normal sterile saline injected bilaterally (for a total volume of 60 mL). 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 (for a total volume of 60 mL).
Pacira BioSciences, Inc. is a holding company for Pacira Pharmaceuticals, Inc. The Company's non-opioid treatments include EXPAREL (bupivacaine liposome injectable suspension), which is a long-acting, local analgesic for postsurgical pain management; ZILRETTA (triamcinolone acetonide extended-release injectable suspension), which is an extended-release, intra-articular (IA), corticosteroid injection indicated for OA knee pain, and Iovera, which is a novel handheld device for delivering immediate, long-acting, drug-free pain control using precise, controlled doses of cold temperature to a targeted nerve. EXPAREL is used across multiple orthopedic procedures, including joint reconstruction, shoulder, spine, extremity procedures, and hip fractures. It is developing interventions to address debilitating conditions involving the sympathetic nervous system, such as cardiac electrical storm, chronic pain. Its clinical development programs include PCRX-201, and pMVL-Based Clinical Program.
Pacira Pharmaceuticals, Inc. Announces EXPAREL Achieves Statistically Significant Reductions in Opioid Consumption and Pain Scores in Cesarean Section Patients