EXPAREL demonstrated statistical significance for the key secondary endpoint of a reduction in the incidence and severity of itching for 72 hours after surgery (P0.05). Full study results will be submitted for publication in the peer-reviewed medical literature later this year.
The Phase 4, multicenter, randomized, active-controlled study across 18 clinical sites in
'Providing safe and effective non-opioid postsurgical pain management is a critical element to helping new mothers recover and care for themselves and their newborn following C-section surgery,' said
The company's previous Phase 4 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.
About
About EXPAREL
EXPAREL (bupivacaine liposome injectable suspension) is indicated for single-dose infiltration in adults to produce postsurgical local analgesia and as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. Safety and efficacy have not been established in other nerve blocks. The product combines bupivacaine with DepoFoam, a proven product delivery technology that delivers medication over a desired time period. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing significant reductions in cumulative pain scores with up to a 78 percent decrease in opioid consumption; the clinical benefit of the opioid reduction was not demonstrated.
Important Safety Information
EXPAREL is contraindicated in obstetrical paracervical block anesthesia. Adverse reactions reported with an incidence greater than or equal to 10% following EXPAREL administration via infiltration were nausea, constipation, and vomiting; adverse reactions reported with an incidence greater than or equal to 10% following EXPAREL administration via interscalene brachial plexus nerve block were nausea, pyrexia, and constipation. If EXPAREL and other non-bupivacaine local anesthetics, including lidocaine, are administered at the same site, there may be an immediate release of bupivacaine from EXPAREL. Therefore, EXPAREL may be administered to the same site 20 minutes after injecting lidocaine. EXPAREL is not recommended to be used in the following patient population: patients
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