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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)

Novartis drug Afinitor significantly reduces seizures in Phase III study of patients with tuberous sclerosis complex
Source: Epilepsy News From Medical News Today [2016.04.22]
Everolimus is the first adjunctive therapy shown in a prospective randomized Phase III study to achieve clinically significant seizure control in TSC patients1.

Everolimus Data for Seizures in Tuberous Sclerosis 'Exciting'
Source: Medscape NeurologyHeadlines [2016.04.21]
The new results may open the door to eventually being able to treat epilepsy, not just seizures, researchers say.
Medscape Medical News

Once-a-day epilepsy drug may prevent seizures as well as twice-a-day drug
Source: Epilepsy News From Medical News Today [2016.04.14]
A new study suggests that an epilepsy drug that can be taken once a day may control seizures as well as a drug that must be taken twice a day, according to a preliminary study presented at the...

Study finds birth control pills may increase risk of seizures in women with epilepsy
Source: Epilepsy News From Medical News Today [2016.03.31]
Could certain types of hormonal contraceptives cause an increase in seizures in women with epilepsy?

Neuron type-specific gene loss linked to Angelman syndrome seizures
Source: Autism News From Medical News Today [2016.03.28]
The gene UBE3A plays a critical role in early neurological development. If UBE3A is overexpressed - or if the enzymatic function of UBE3A protein is hyperactive - autism ensues.

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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)

Effect of Rufinamide on Chronic Postthoracotomy Pain Syndrome [Withdrawn]
The purpose of this study is to test if rufinamide has an effect on chronic neuropathic pain in patients with a post thoracotomy pain syndrome.

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 [Active, not recruiting]

Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures [Completed]
The primary objective of this study is to evaluate the effect of rufinamide on total partial seizure frequency in adolescent and adult patients with refractory partial onset seizures currently inadequately treated with a maximum of three stable antiepileptic medications. Secondary objectives are to evaluate the effect of rufinamide on secondary and exploratory outcomes, to confirm the safety profile of rufinamide, and to assess the relationship between rufinamide plasma concentration and efficacy.

Open-Label Extension Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures [Completed]
This study is an open-label extension of Study E2080-A001-301. All patients will initiate the study at the total daily doses they were receiving at the end of the transition phase in E2080-A001-301 (2400 or 3200 mg/day) with an option, at the discretion of the Investigator, to incrementally increase doses to a maximum of 4800 mg/day. Safety variables and seizure frequency will be monitored throughout the study.

Exploratory Study to Evaluate the Effect of SYN111 (Rufinamide) in Patients With Generalized Anxiety Disorder (GAD) [Completed]
This is an eight week, randomized, double blind, placebo-controlled, exploratory study. Patients randomized to rufinamide (SYN111) will receive 250 mg BID (total daily dose 500mg) for one week then have their dose increased to 500 mg BID (total daily dose 1000mg) for the remaining 7 weeks of the study. If the 500 mg BID dose is not tolerated, one dose reduction is allowed.

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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: 2016-04-22

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