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Banzel (Rufinamide) - Summary

 
 



BANZEL SUMMARY

BANZEL™ (rufinamide) Tablets

BANZEL (rufinamide) is a triazole derivative structurally unrelated to currently marketed antiepileptic drugs (AEDs).

BANZEL (rufinamide) is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in children 4 years and older and adults.


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NEWS HIGHLIGHTS

Media Articles Related to Banzel (Rufinamide)

New indication for VIMPAT®: anti-epileptic drug approved by FDA as monotherapy in the treatment of patients with partial-onset seizures
Source: Epilepsy News From Medical News Today [2014.09.03]
UCB has announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for VIMPAT® (lacosamide) C-V as monotherapy in the treatment of...

Potential treatments for absence seizures
Source: Epilepsy News From Medical News Today [2014.08.25]
Absence seizures are believed to be elicited by T-type calcium channels in the thalamic reticular nucleus of the brain that regulate influxes of calcium.

Two Drugs Work Equally Well for Epileptic Seizures in Kids: Study
Source: MedicineNet lorazepam Specialty [2014.04.23]
Title: Two Drugs Work Equally Well for Epileptic Seizures in Kids: Study
Category: Health News
Created: 4/22/2014 4:36:00 PM
Last Editorial Review: 4/23/2014 12:00:00 AM

Febrile Seizures
Source: MedicineNet Roseola Specialty [2014.01.15]
Title: Febrile Seizures
Category: Diseases and Conditions
Created: 5/9/2008 12:00:00 AM
Last Editorial Review: 1/15/2014 12:00:00 AM

Most Vaccination-Onset Epilepsy Has Genetic, Structural Cause
Source: Medscape Infectious Diseases Headlines [2014.09.24]
A new study shows that most seizures beginning after vaccination have an underlying genetic or structural cause, which should increase faith in vaccine safety, researchers say.
Medscape Medical News

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Published Studies Related to Banzel (Rufinamide)

Efficacy of rufinamide in drug-resistant epilepsy: a meta-analysis. [2011.05]
Rufinamide is a new orally active antiepileptic drug that has been found to be effective in the treatment of partial seizures and drop attacks associated with Lennox-Gastaut syndrome. We performed a quantitative analysis of the efficacy of this new antiepileptic drug from all double-blind, add-on, randomized, placebo-controlled clinical trials published to date.

Rufinamide for the treatment of Lennox-Gastaut syndrome. [2011.04]
INTRODUCTION: Lennox-Gastaut syndrome (LGS) is a severe treatment-resistant childhood-onset epilepsy. This review examines the role of the new drug rufinamide for the treatment of LGS...

A randomized, double-blind, placebo-controlled, parallel-group study of rufinamide as adjunctive therapy for refractory partial-onset seizures. [2011.02]
PURPOSE: Efficacy and safety of adjunctive rufinamide (3,200 mg/day) was assessed in adolescents and adults with inadequately controlled partial-onset seizures receiving maintenance therapy with up to three antiepileptic drugs (AEDs)... CONCLUSIONS: Adjunctive treatment with rufinamide reduced total partial seizures in refractory patients. AEs reported were consistent with the known tolerability profile of rufinamide. Wiley Periodicals, Inc. (c) 2010 International League Against Epilepsy.

Bioavailability of three rufinamide oral suspensions compared with the marketed 400-mg tablet formulation: results from a randomized-sequence, open-label, four-period, four-sequence crossover study in healthy subjects. [2011.01]
BACKGROUND: Rufinamide is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in patients aged >/=4 years. OBJECTIVES: The primary purpose of this study was to compare the relative bioavailability and other pharmacokinetics of rufinamide administered as a 400-mg tablet formulation (reference) with 10 mL of a newly developed 40-mg/mL suspension (test) manufactured using 3 different homogenization speeds in healthy subjects under fed conditions. The study also explored whether homogenization speed had any effect on rufinamide pharmacokinetics when administered as a suspension formulation... CONCLUSION: This single-dose study in a small population of fed, healthy subjects found no statistically significant differences in relative bioavailability among each of the 3 test suspensions and the currently marketed 400-mg tablet formulation of rufinamide, meeting FDA and EMA regulatory requirements for assuming bioequivalence. Copyright (c) 2011 Elsevier HS Journals, Inc. All rights reserved.

Update on rufinamide in childhood epilepsy. [2011]
Rufinamide is an orally active, structurally novel compound (1-[(2,6-difluorophenil1) methyl1]-1 hydro 1,2,3-triazole-4 carboxamide), which is structurally distinct from other anticonvulsant drugs. It was granted orphan drug status for the adjunctive treatment of Lennox-Gastaut syndrome (LGS) in the United States in 2004, and released for use in Europe in 2007.

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Clinical Trials Related to Banzel (Rufinamide)

Study of Rufinamide in Pediatric Subjects 1 to Less Than 4 Years of Age With Lennox-Gastaut Syndrome Inadequately Controlled With Other Anti-epileptic Drugs [Recruiting]

A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients [Recruiting]
To confirm that the combination therapy of rufinamide has superior efficacy compared to placebo in patients with Lennox-Gastaut syndrome.

Effect of Oral Rufinamide and Oxcarbazepine on Nerve Excitability, Hyperalgesia, Allodynia and Flare Reaction Compared to Placebo. A Monocenter, Randomized, Double-blind, Cross-over Study [Recruiting]
Untersuchungen über die Wirkmechanismen von Antiepileptika haben gezeigt, dass durch eine Blockierung von spannungsabhängigen Natrium-Kanälen im Nervensystem die Schmerzübertragung moduliert werden kann. Verschiedene Antiepileptika werden in der chronischen Schmerztherapie schon lange angewendet (z. B. Oxcarbazepinum, Trileptal ® bei Trigeminusneuralgie oder diabetischer Polyneuropathie).

In unserer Untersuchung wollen wir zwei in der Schweiz zugelassene Antiepileptika bezüglich ihrer Wirkung auf das Schmerzempfinden untersuchen. Eines dieser Medikamente, Trileptal® (Wirkstoff: Oxcarbazepinum), wird schon häufig bei chronischen Schmerzzuständen eingesetzt. Das zweite Medikament, Inovelon® (Wirkstoff: Rufinamid) ist seit mehr als einem Jahr in der Schweiz zugelassen und wird klinisch vor allem in der Behandlung von besonderen Epilepsieformen im Kindesalter eingesetzt. Wir erwarten, dass auch nach Gabe von Inovelon® die Schmerzleitung in den Nervenzellen verändert und die lokalen Schmerzreaktionen in der Haut vermindert werden.

- Trial with medicinal product

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Reports of Suspected Banzel (Rufinamide) Side Effects

Vomiting (4)Pneumonia Aspiration (3)Dehydration (3)Aphasia (2)Sudden Unexplained Death in Epilepsy (2)Emotional Disorder (2)Crying (2)Blood Potassium Decreased (2)Confusional State (1)Excessive Eye Blinking (1)more >>


Page last updated: 2014-09-24

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