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Drug Profiles

USL255 extended-release topiramate for the treatment of epilepsy

References

  • Birbeck GL. Epilepsy care in developing countries: part II of II. Epilepsy Curr 2010;10(5):105-10
  • Hauser WA, Annegers JF, Kurland LT. Incidence of epilepsy and unprovoked seizures in Rochester, Minnesota: 1935-1984. Epilepsia 1993;34(3):453-68
  • Joensen P. Prevalence, incidence, and classification of epilepsy in the Faroes. Acta Neurol Scand 1986;74(2):150-5
  • Lavados J, Germain L, Morales A, et al. A descriptive study of epilepsy in the district of El Salvador, Chile, 1984-1988. Acta Neurol Scand 1992;85(4):249-56
  • Forsgren L, Bucht G, Eriksson S, Bergmark L. Incidence and clinical characterization of unprovoked seizures in adults: a prospective population-based study. Epilepsia 1996;37(3):224-9
  • Kwan P, Brodie MJ. Emerging drugs for epilepsy. Expert Opin Emerg Drugs 2007;12(3):407-22
  • Schiller Y, Najjar Y. Quantifying the response to antiepileptic drugs: effect of past treatment history. Neurology 2008;70(1):54-65
  • Brodie MJ. Road to refractory epilepsy: the Glasgow story. Epilepsia 2013;54(Suppl 2):5-8
  • Baker GA. The psychosocial burden of epilepsy. Epilepsia 2002;43 Suppl 6:26-30
  • Eatock J, Baker GA. Managing patient adherence and quality of life in epilepsy. Neuropsychiatr Dis Treat 2007;3(1):117-31
  • Qudexy™ XR (topiramate extended-release) Prescribing Information. Upsher-Smith Laboratories, Inc; Maple Grove, MN, US: 2014
  • Trevathan E, Murphy CC, Yeargin-Allsopp M. Prevalence and descriptive epidemiology of Lennox-Gastaut syndrome among Atlanta children. Epilepsia 1997;38(12):1283-8
  • Lyseng-Williamson KA, Yang LP. Spotlight on topiramate in epilepsy. CNS Drugs 2008;22(2):171-4
  • Topamax® (topiramate) Prescribing Information. Janssen Pharmaceuticals, Inc; Titusville, NJ, US: 2014
  • Study to evaluate the safety and effectiveness of USL255 in patients with refractory partial-onset seizures. Available from: http://clinicaltrials.gov/show/NCT01142193
  • Chung S, Fakhoury T, Hogan R, et al. Once-daily USL255 as adjunctive treatment of partial-onset seizures: randomized Phase III study. Epilepsia 2014;55(7):1077-87
  • Brodie MJ, Kwan P. Newer drugs for focal epilepsy in adults. BMJ 2012;344:e345
  • Cramer JA, Glassman M, Rienzi V. The relationship between poor medication compliance and seizures. Epilepsy Behav 2002;3(4):338-42
  • Bialer M. Extended-release formulations for the treatment of epilepsy. CNS Drugs 2007;21(9):765-74
  • Leppik IE, Hovinga CA. Extended-release antiepileptic drugs: a comparison of pharmacokinetic parameters relative to original immediate-release formulations. Epilepsia 2013;54(1):28-35
  • Topiramate extended-release (Trokendi XR) for epilepsy. Med Lett Drugs Ther 2013;55(1428):87-8
  • Hanada T. The discovery and development of perampanel for the treatment of epilepsy. Expert Opin Drug Discov 2014;9(4):449-58
  • Mula M. Brivaracetam for the treatment of epilepsy in adults. Expert Rev Neurother 2014;14(4):361-5
  • Manitpisitkul P, Shalayda K, Todd M, et al. Pharmacokinetics and safety of adjunctive topiramate in infants (1-24 months) with refractory partial-onset seizures: a randomized, multicenter, open-label phase 1 study. Epilepsia 2013;54(1):156-64
  • Lenz RA, Elterman RD, Robieson WZ, et al. Divalproex sodium in children with partial seizures: 12-month safety study. Pediatr Neurol 2009;41(2):101-10
  • Lamictal® (lamotrigine) Prescribing Information. GlaxoSmithKline; Research Triangle Park, NC, US: 2014
  • Tegretol® (carbamazepine) Prescribing Information. Novartis; East Hanover, NJ, US: 2014
  • Vimpat® (lacosamide) Prescribing Information. UCB Pharma; Smyrna, GA, US: 2014
  • Depakene® (valproic acid) Prescribing Information. AbbVie Inc; Chicago, IL, US: 2014
  • Dilantin® (phenytoin extended-release) Prescribing Information. Parke-Davis Division of Pfizer Inc; New York, NY, US: 2014
  • Topiramate - Compound Summary (CID 5284627). NCBI PubChem; 2013
  • Sills GJ, Butler E, Thompson GG, Brodie MJ. Pharmacodynamic interaction studies with topiramate in the pentylenetetrazol and maximal electroshock seizure models. Seizure 2004;13(5):287-95
  • Luszczki JJ, Jankiewicz K, Jankiewicz M, Czuczwar SJ. Pharmacokinetic and pharmacodynamic interactions of aminophylline and topiramate in the mouse maximal electroshock-induced seizure model. Eur J Pharmacol 2007;562(1-2):53-9
  • Wauquier A, Zhou S. Topiramate: a potent anticonvulsant in the amygdala-kindled rat. Epilepsy Res 1996;24(2):73-7
  • Grabenstatter HL, Ferraro DJ, Williams PA, et al. Use of chronic epilepsy models in antiepileptic drug discovery: the effect of topiramate on spontaneous motor seizures in rats with kainate-induced epilepsy. Epilepsia 2005;46(1):8-14
  • Halvorsen MB, Lambrecht LJ, Boulware MJ, Todd WM. Extended-release topiramate (USL255) exhibits linear dose-proportional pharmacokinetic characteristics [abstract]. Neurology 2012;78:P06.128
  • Lambrecht LJ, Halvorsen MB, Braun TL, Todd WM. Establishing maximum tolerated dose and dose-proportionality in extended-release topiramate (USL255) [abstract]. Epilepsy Curr 2013;13(Suppl 1):425-3.233
  • Clark AM, Halvorsen MB, Braun TL, et al. USL255 extended-release topiramate: dose-proportional pharmacokinetics and tolerability in healthy volunteers. Epilepsia 2014;55(7):1069-76
  • Lambrecht LJ, Shekh-Ahmad T, Todd WM, et al. Comparative pharmacokinetic analysis of USL255, a new once-daily extended-release formulation of topiramate. Epilepsia 2011;52(10):1877-83
  • Bialer M, Shekh-Ahmad T, Braun TL, Halvorsen MB. Comparative steady-state pharmacokinetic evaluation of immediate-release topiramate and USL255, a once-daily extended-release topiramate formulation. Epilepsia 2013;54(8):1444-52
  • Clark A, Anders B, Halvorsen M. Comparison of the pharmacokinetics of USL255, an extended-release topiramate, when sprinkled onto food or swallowed intact. Epilepsy Currents 2014;14(1 Suppl):104
  • Anders B, Lu Q, Ludwig E, et al. Impact of delayed-dose administration of USL255, an extended-release topiramate formulation [abstract]. Epilepsy Currents 2014;14(1 Suppl):224
  • Shank RP, Doose DR, Streeter AJ, Bialer M. Plasma and whole blood pharmacokinetics of topiramate: the role of carbonic anhydrase. Epilepsy Res 2005;63(2-3):103-12
  • Garnett WR. Clinical pharmacology of topiramate: a review. Epilepsia 2000;41(Suppl 1):S61-5
  • Bialer M, Doose DR, Murthy B, et al. Pharmacokinetic interactions of topiramate. Clin Pharmacokinet 2004;43(12):763-80
  • Britzi M, Perucca E, Soback S, et al. Pharmacokinetic and metabolic investigation of topiramate disposition in healthy subjects in the absence and in the presence of enzyme induction by carbamazepine. Epilepsia 2005;46(3):378-84
  • Mimrod D, Specchio LM, Britzi M, et al. A comparative study of the effect of carbamazepine and valproic acid on the pharmacokinetics and metabolic profile of topiramate at steady state in patients with epilepsy. Epilepsia 2005;46(7):1046-54
  • Open-label extension study to evaluate the safety of USL255 in patients with refractory partial-onset seizures. Available from: http://clinicaltrials.gov/show/NCT01191086
  • Fakhoury T, Chung S, Anders B, et al. Long-term open-label extension (OLE) study evaluating the safety and efficacy of USL255, once-daily extended-release topiramate, in patients with partial-onset seizures: interim analysis from PREVAIL OLE [abstract]. Epilepsy Currents 2014;14(Suppl 1):204
  • Rheims S, Perucca E, Cucherat M, Ryvlin P. Factors determining response to antiepileptic drugs in randomized controlled trials. A systematic review and meta-analysis. Epilepsia 2011;52(2):219-33
  • Baulac M, Leon T, O’Brien TJ, et al. A comparison of pregabalin, lamotrigine, and placebo as adjunctive therapy in patients with refractory partial-onset seizures. Epilepsy Res 2010;91(1):10-19
  • Blatt I, Nagaraddi V, Anders B, et al. USL255 is efficacious across all partial-onset seizure types and with a variety of concomitant antiepileptic drugs: results from subgroup analyses of the phase 3 PREVAIL clinical trial [abstract]. Epilepsy Currents 2014;14(Suppl 1):204
  • Cramer JA, Mintzer S, Wheless J, Mattson RH. Adverse effects of antiepileptic drugs: a brief overview of important issues. Expert Rev Neurother 2010;10(6):885-91
  • Sommer BR, Mitchell EL, Wroolie TE. Topiramate: effects on cognition in patients with epilepsy, migraine headache and obesity. Ther Adv Neurol Disord 2013;6(4):211-27
  • Jette NJ, Marson AG, Hutton JL. Topiramate add-on for drug-resistant partial epilepsy (Review). In: The cochrane library. John Wiley & Sons, Ltd; 2007
  • Perucca E. Extended-release formulations of antiepileptic drugs: rationale and comparative value. Epilepsy Curr 2009;9(6):153-7
  • Faught E, Wilder BJ, Ramsay RE, et al. Topiramate placebo-controlled dose-ranging trial in refractory partial epilepsy using 200-, 400-, and 600-mg daily dosages. Topiramate YD Study Group. Neurology 1996;46(6):1684-90
  • Guberman A, Neto W, Gassmann-Mayer C. Low-dose topiramate in adults with treatment-resistant partial-onset seizures. Acta Neurol Scand 2002;106(4):183-9
  • Pellock JM, Smith MC, Cloyd JC, et al. Extended-release formulations: simplifying strategies in the management of antiepileptic drug therapy. Epilepsy Behav 2004;5(3):301-7
  • Trokendi XR™ (topiramate) prescribing information. Supernus Pharmaceuticals; Rockville, MD, US: 2013
  • Lamictal® XR™ (lamotrigine extended-release) prescribing information. GlaxoSmithKline; Research Triangle Park, NC, US: 2014
  • Banerjee PN, Filippi D, Allen Hauser W. The descriptive epidemiology of epilepsy-a review. Epilepsy Res 2009;85(1):31-45
  • Leppik IE, Birnbaum AK. Epilepsy in the elderly. Ann N Y Acad Sci 2010;1184:208-24
  • Sura L, Madhavan A, Carnaby G, Crary MA. Dysphagia in the elderly: management and nutritional consideration. Clin Interv Aging 2012;7:287-98
  • Stefan H. Improving the effectiveness of drugs in epilepsy through concordance. ACNR 2009;8(6):15-18
  • Pellock JM, Morton LD. Treatment of epilepsy in the multiply handicapped. Ment Retard Dev Disabil Res Rev 2000;6(4):309-23
  • Margolis JM, Chu BC, Wang ZJ, et al. Effectiveness of antiepileptic drug combination therapy for partial-onset seizures based on mechanisms of action. JAMA Neurol 2014;71(8):985-93
  • Poolos NP, Warner LN, Humphreys SZ, Williams S. Comparative efficacy of combination drug therapy in refractory epilepsy. Neurology 2012;78(1):62-8
  • Pisani F, Oteri G, Russo MF, et al. The efficacy of valproate-lamotrigine comedication in refractory complex partial seizures: evidence for a pharmacodynamic interaction. Epilepsia 1999;40(8):1141-6
  • Deckers CL, Czuczwar SJ, Hekster YA, et al. Selection of antiepileptic drug polytherapy based on mechanisms of action: the evidence reviewed. Epilepsia 2000;41(11):1364-74
  • Brodie MJ, Sills GJ. Combining antiepileptic drugs–rational polytherapy? Seizure 2011;20(5):369-75
  • Girgis IG, Nandy P, Nye JS, et al. Pharmacokinetic-pharmacodynamic assessment of topiramate dosing regimens for children with epilepsy 2 to <10 years of age. Epilepsia 2010;51(10):1954-62
  • Pellock JM, Carman WJ, Thyagarajan V, et al. Efficacy of antiepileptic drugs in adults predicts efficacy in children: a systematic review. Neurology 2012;79(14):1482-9
  • Naritoku DK, Warnock CR, Messenheimer JA, et al. Lamotrigine extended-release as adjunctive therapy for partial seizures. Neurology 2007;69(16):1610-18
  • Biton V, Di Memmo J, Shukla R, et al. Adjunctive lamotrigine XR for primary generalized tonic-clonic seizures in a randomized, placebo-controlled study. Epilepsy Behav 2010;19(3):352-8
  • Peltola J, Coetzee C, Jimenez F, et al. Once-daily extended-release levetiracetam as adjunctive treatment of partial-onset seizures in patients with epilepsy: a double-blind, randomized, placebo-controlled trial. Epilepsia 2009;50(3):406-14
  • French JA, Baroldi P, Brittain ST, Johnson JK; Group PIS. Efficacy and safety of extended-release oxcarbazepine (Oxtellar XR) as adjunctive therapy in patients with refractory partial-onset seizures: a randomized controlled trial. Acta Neurol Scand 2014;129(3):143-53
  • Carbatrol® (carbamazepine extended-release) prescribing information. Shire US Inc; Wayne, PA, US: 2013
  • Depakote® ER (divalproex sodium extended-release) prescribing information. Abbott Laboratories; North Chicago, IL, US: 2002
  • Keppra XR® (levetiracetam extended-release) prescribing information. UCB Pharma; Smyrna, GA, US: 2014
  • Oxtellar XR® (oxcarbazepine extended-release) prescribing information. Supernus Pharmaceuticals; Rockville, MD, US: 2012
  • Phenytek® (phenytoin extended-release) prescribing information. Mylan Pharmaceuticals Inc; Morgantown, WV US: 2014

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