The most common treatment emergent adverse events (TEAEs) reported with EXPAREL were nausea, constipation, and vomiting. Medication was administered into the surgical site in subjects undergoing hemorrhoidectomy, 3 5 inguinal hernia repair, 6,7 breast augmentation, 8,9 bunionectomy, 10 and total knee arthroplasty (TKA) In total, 823 subjects have been studied with EXPAREL administration into the surgical site via infiltration in a variety of surgical settings providing a robust safety database. 2 In addition eight Phase 2 and 3 clinical trials comparing EXPAREL to unencapsulated bupivacaine HCl have been conducted. The trial also met other secondary endpoints related to pain measurement and the use of opioid rescue medication. 1 In the Phase 3 bunionectomy trial, EXPAREL demonstrated a statistically significant reduction in pain at 24 hours (primary endpoint), and this reduction was also statistically significant at 36 hours (secondary endpoint). In addition, EXPAREL reduced the use of opioid rescue medication, including 45% less opioid usage compared with placebo at 72 hours (secondary endpoint). 2 In the Phase 3 hemorrhoidectomy trial, EXPAREL achieved a statistically significant 30% reduction in pain, as measured by the area under the curve (AUC) of the numeric rating scale at rest (NRS R) pain scores, at 72 hours (primary endpoint) and all additional time points measured up to 72 hours. The efficacy and safety of EXPAREL as a treatment for postsurgical pain following single dose local administration was established in 2 multicenter, randomized, double blind, placebo controlled, pivotal Phase 3 clinical trials in subjects undergoing hemorrhoidectomy 1 or bunionectomy. After injection of EXPAREL into soft tissue, bupivacaine is released from the multivesicular liposomes providing effective local analgesia for up to 72 hours. 1 AMCP Dossier EXPAREL (bupivacaine liposome injectable suspension)Ģ Contents 1 Executive Summary Clinical Benefits Conclusions Product Information and Disease Description6 2.1 Product Description Generic Name, Brand Name, and Therapeutic Class Dosage Forms, Strengths, and Package Sizes NDC for all Formulations WAC Cost per Unit AHFS or Other Drug Classification FDA Approved Indications Pharmacology Pharmacokinetics/Pharmacodynamics Contraindications Warnings/Precautions/Adverse Effects Interactions Specific Populations/Disease Dosing and Administration Access Co Prescribed/Concomitant Therapies Comparison Products Place of the Product in Therapy Disease Description Approaches to Treatment Relevant Treatment Guidelines and Consensus Statements From National and/or International Bodies Supporting Clinical Evidence Summarizing Key Clinical Studies Published and Unpublished Data and Clinical Studies Supporting Labelled Indications Clinical Studies Supporting Off label Indications (Administration Other Than by Wound Infiltration) Clinical Evidence Summary Table Summarizing of Evidence from Secondary Sources Integrated Analysis of Efficacy and Safety Integrated Cardiac Safety Analysis Economic Value and Modelling Report Modelling Overview References EXPAREL Dossier ģ 1 Executive Summary 1.1 Clinical Benefits EXPAREL is a liposome injection of bupivacaine, an amide type local anesthetic, indicated for single dose local administration into the surgical site to produce postsurgical analgesia.
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