Rufinamide was approved by the US Food and Drug Administration (FDA) in November 2008, as adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in children four years and older and adults. Its official FDA-approved labeling does not mention use in the treatment of partial seizures inasmuch as clinical trials submitted to the FDA were marginal. However, several recent clinical trials suggest that the drug has efficacy for partial seizures [4] It is marketed under the brand name Banzel.[5] It is also marketed in the European Union under the brand name Inovelon.[6] It is available as a generic medication.[7]
The mechanism of action of rufinamide is not fully understood. There is some evidence that rufinamide can modulate the gating of voltage-gated sodium channels,[8][9] a common target for antiepileptic drugs.[10] A recent study indicates subtle effects on the voltage-dependence of gating and the time course of inactivation in some sodium channel isoforms that could reduce neuronal excitability.[11] However, this action cannot explain the unique spectrum of activity of rufinamide.
Referencesedit
^Anvisa (31 March 2023). "RDC Nº 784 - Listas de Substâncias Entorpecentes, Psicotrópicas, Precursoras e Outras sob Controle Especial" [Collegiate Board Resolution No. 784 - Lists of Narcotic, Psychotropic, Precursor, and Other Substances under Special Control] (in Brazilian Portuguese). Diário Oficial da União (published 4 April 2023). from the original on 3 August 2023. Retrieved 16 August 2023.
^ ab"Banzel- rufinamide tablet, film coated Banzel- rufinamide suspension". DailyMed. 15 April 2020. Retrieved 21 October 2020.
^Hakimian S, Cheng-Hakimian A, Anderson GD, Miller JW (August 2007). "Rufinamide: a new anti-epileptic medication". Expert Opinion on Pharmacotherapy. 8 (12): 1931–1940. doi:10.1517/14656566.8.12.1931. PMID 17696794. S2CID 19522242.
^Brodie MJ, Rosenfeld WE, Vazquez B, Sachdeo R, Perdomo C, Mann A, Arroyo S (August 2009). "Rufinamide for the adjunctive treatment of partial seizures in adults and adolescents: a randomized placebo-controlled trial". Epilepsia. 50 (8): 1899–1909. doi:10.1111/j.1528-1167.2009.02160.x. PMID 19490053. S2CID 38485532.
^FDA press release - FDA Approves New Drug to Treat Severe Form of Epilepsy
^. Archived from the original on 14 March 2009. Retrieved 25 November 2008.
^"2022 First Generic Drug Approvals". U.S. Food and Drug Administration (FDA). 3 March 2023. from the original on 30 June 2023. Retrieved 30 June 2023.
^Rogawski MA (June 2006). "Diverse mechanisms of antiepileptic drugs in the development pipeline". Epilepsy Research. 69 (3): 273–294. doi:10.1016/j.eplepsyres.2006.02.004. PMC1562526. PMID 16621450.
^Striano P, McMurray R, Santamarina E, Falip M (February 2018). "Rufinamide for the treatment of Lennox-Gastaut syndrome: evidence from clinical trials and clinical practice". Epileptic Disorders. 20 (1): 13–29. doi:10.1684/epd.2017.0950. PMID 29313492.
^Rogawski MA, Löscher W (July 2004). "The neurobiology of antiepileptic drugs". Nature Reviews. Neuroscience. 5 (7): 553–564. doi:10.1038/nrn1430. PMID 15208697. S2CID 2201038.
^Gilchrist J, Dutton S, Diaz-Bustamante M, McPherson A, Olivares N, Kalia J, et al. (May 2014). "Nav1.1 modulation by a novel triazole compound attenuates epileptic seizures in rodents". ACS Chemical Biology. 9 (5): 1204–1212. doi:10.1021/cb500108p. PMC4027953. PMID 24635129.
External linksedit
"Rufinamide". Drug Information Portal. U.S. National Library of Medicine.
rufinamide, confused, with, ralfinamide, anticonvulsant, medication, used, combination, with, other, medication, therapy, treat, lennox, gastaut, syndrome, various, other, seizure, disorders, triazole, derivative, developed, 2004, novartis, pharma, manufacture. Not to be confused with ralfinamide Rufinamide is an anticonvulsant medication It is used in combination with other medication and therapy to treat Lennox Gastaut syndrome 3 and various other seizure disorders Rufinamide a triazole derivative was developed in 2004 by Novartis Pharma AG and is manufactured by Eisai RufinamideClinical dataTrade namesBanzel InovelonAHFS Drugs comMonographMedlinePlusa609001License dataEU EMA by INN US DailyMed Rufinamide US FDA RufinamidePregnancycategoryAU B3Routes ofadministrationBy mouthATC codeN03AF03 WHO Legal statusLegal statusBR Class C1 Other controlled substances 1 UK POM Prescription only US only 2 In general Prescription only Pharmacokinetic dataBioavailability85 under fed conditions tmax 4 6 hoursProtein binding34 MetabolismCarboxylesterase mediated hydrolysis CYP not involved MetabolitesInactiveElimination half life6 10 hoursExcretionUrine 85 2 IdentifiersIUPAC name 1 2 6 Difluorobenzyl 1H 1 2 3 triazole 4 carboxamideCAS Number106308 44 5 NPubChem CID129228IUPHAR BPS7470ChemSpider114471 YUNIIWFW942PR79KEGGD05775ChEMBLChEMBL1201754 NCompTox Dashboard EPA DTXSID1046506Chemical and physical dataFormulaC 10H 8F 2N 4OMolar mass238 198 g mol 13D model JSmol Interactive imageSMILES O C c1nnn c1 Cc2c F cccc2F NInChI InChI 1S C10H8F2N4O c11 7 2 1 3 8 12 6 7 4 16 5 9 10 13 17 14 15 16 h1 3 5H 4H2 H2 13 17 YKey POGQSBRIGCQNEG UHFFFAOYSA N Y N Y what is this verify Rufinamide was approved by the US Food and Drug Administration FDA in November 2008 as adjunctive treatment of seizures associated with Lennox Gastaut syndrome in children four years and older and adults Its official FDA approved labeling does not mention use in the treatment of partial seizures inasmuch as clinical trials submitted to the FDA were marginal However several recent clinical trials suggest that the drug has efficacy for partial seizures 4 It is marketed under the brand name Banzel 5 It is also marketed in the European Union under the brand name Inovelon 6 It is available as a generic medication 7 The mechanism of action of rufinamide is not fully understood There is some evidence that rufinamide can modulate the gating of voltage gated sodium channels 8 9 a common target for antiepileptic drugs 10 A recent study indicates subtle effects on the voltage dependence of gating and the time course of inactivation in some sodium channel isoforms that could reduce neuronal excitability 11 However this action cannot explain the unique spectrum of activity of rufinamide References edit Anvisa 31 March 2023 RDC Nº 784 Listas de Substancias Entorpecentes Psicotropicas Precursoras e Outras sob Controle Especial Collegiate Board Resolution No 784 Lists of Narcotic Psychotropic Precursor and Other Substances under Special Control in Brazilian Portuguese Diario Oficial da Uniao published 4 April 2023 Archived from the original on 3 August 2023 Retrieved 16 August 2023 a b Banzel rufinamide tablet film coated Banzel rufinamide suspension DailyMed 15 April 2020 Retrieved 21 October 2020 Hakimian S Cheng Hakimian A Anderson GD Miller JW August 2007 Rufinamide a new anti epileptic medication Expert Opinion on Pharmacotherapy 8 12 1931 1940 doi 10 1517 14656566 8 12 1931 PMID 17696794 S2CID 19522242 Brodie MJ Rosenfeld WE Vazquez B Sachdeo R Perdomo C Mann A Arroyo S August 2009 Rufinamide for the adjunctive treatment of partial seizures in adults and adolescents a randomized placebo controlled trial Epilepsia 50 8 1899 1909 doi 10 1111 j 1528 1167 2009 02160 x PMID 19490053 S2CID 38485532 FDA press release FDA Approves New Drug to Treat Severe Form of Epilepsy European Public Assessment Report for rufinamide INOVELON Archived from the original on 14 March 2009 Retrieved 25 November 2008 2022 First Generic Drug Approvals U S Food and Drug Administration FDA 3 March 2023 Archived from the original on 30 June 2023 Retrieved 30 June 2023 Rogawski MA June 2006 Diverse mechanisms of antiepileptic drugs in the development pipeline Epilepsy Research 69 3 273 294 doi 10 1016 j eplepsyres 2006 02 004 PMC 1562526 PMID 16621450 Striano P McMurray R Santamarina E Falip M February 2018 Rufinamide for the treatment of Lennox Gastaut syndrome evidence from clinical trials and clinical practice Epileptic Disorders 20 1 13 29 doi 10 1684 epd 2017 0950 PMID 29313492 Rogawski MA Loscher W July 2004 The neurobiology of antiepileptic drugs Nature Reviews Neuroscience 5 7 553 564 doi 10 1038 nrn1430 PMID 15208697 S2CID 2201038 Gilchrist J Dutton S Diaz Bustamante M McPherson A Olivares N Kalia J et al May 2014 Nav1 1 modulation by a novel triazole compound attenuates epileptic seizures in rodents ACS Chemical Biology 9 5 1204 1212 doi 10 1021 cb500108p PMC 4027953 PMID 24635129 External links edit Rufinamide Drug Information Portal U S National Library of Medicine Portal nbsp Medicine Retrieved from https en wikipedia org w index php title Rufinamide amp oldid 1217794244, wikipedia, wiki, book, books, library,
