Eslicarbazepine acetate: A new option for the treatment of focal epilepsy

Expert Opinion on Investigational Drugs

Volumn 18, Issue 2, 2009, Pages 221-229

  Mestre, Tiago ^b   Ferreira, Joaquim J ^a  

^a INSTITUTO DE MEDICINA MOLECULAR   (Portugal)

^b INSTITUTO DE MEDICINA MOLECULAR JOÃO LOBO ANTUNES   (Portugal)

Author keywords

Antiepileptic drugs; Eslicarbazepine acetate; Focal onset epilepsy; Refractory epilepsy

Indexed keywords

ACETAZOLAMIDE; CARBAMAZEPINE; CLOBAZAM; CLONAZEPAM; DIGOXIGENIN; DIGOXIN; ESLICARBAZEPINE ACETATE; ETIRACETAM; GABAPENTIN; LAMOTRIGINE; ORAL CONTRACEPTIVE AGENT; OXCARBAZEPINE; PHENOBARBITAL; PHENYTOIN; PLACEBO; PRIMIDONE; TOPIRAMATE; VALPROIC ACID; VOLTAGE GATED SODIUM CHANNEL; WARFARIN; ANTICONVULSIVE AGENT; DIBENZAZEPINE DERIVATIVE;

BLURRED VISION; CLINICAL TRIAL; COORDINATION; DIPLOPIA; DIZZINESS; DOSAGE SCHEDULE COMPARISON; DRUG CLEARANCE; DRUG DOSE INCREASE; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG ELIMINATION; DRUG HALF LIFE; DRUG MANUFACTURE; DRUG MARKETING; DRUG METABOLISM; DRUG PROTEIN BINDING; DRUG SAFETY; DRUG STRUCTURE; DRUG TRANSFORMATION; DRUG WITHDRAWAL; FATIGUE; FOCAL EPILEPSY; HEADACHE; HUMAN; HYPONATREMIA; INHIBITION KINETICS; MEDLINE; NAUSEA; PHARMACODYNAMICS; PLASMA CONCENTRATION-TIME CURVE; QT INTERVAL; RASH; REVIEW; SIDE EFFECT; SOMNOLENCE; TIME TO MAXIMUM PLASMA CONCENTRATION; TONIC CLONIC SEIZURE; VERTIGO; VITAL SIGN; VOMITING; ANIMAL; CHEMISTRY; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; TREATMENT OUTCOME;

ANIMALS; ANTICONVULSANTS; CLINICAL TRIALS, PHASE II AS TOPIC; CLINICAL TRIALS, PHASE III AS TOPIC; DIBENZAZEPINES; EPILEPSIES, PARTIAL; HUMANS; TREATMENT OUTCOME;

EID: 65549110861     PISSN: 13543784     EISSN: None     Source Type: Journal    
DOI: 10.1517/13543780802635107     Document Type: Review

References (41)

1. Fisher RS vEBW, Blume W, Elger C, et al. Epileptic seizures and epilepsy: definitions proposed by the International League Against Epilepsy (ILAE) and the International Bureau for Epilepsy (IBE). Epilepsia 2005;46:1698-1699
2. Sander JW. The epidemiology of epilepsy revisited. Curr Opin Neurol 2003;16:165-170 (Pubitemid 36521202)
3. EMEA/CPMP: Committee for Proprietary Medicinal Products (CPMP). Note for guidance on clinical investigation of medicinal products in the treatment of epileptic disorders. London, 16 November 2000 (CPMP/EWP/566/98 Rev. 1)
4. Perucca EFJ, Bialer M. Development of new antiepileptic drugs: challenges, incentives, and recent advances. Lancet Neurol 2007;6:793-804 (Pubitemid 47243712)
5. French JA, Kanner AM, Bautista J, et al. Efficacy and tolerability of the new antiepileptic drugs II: treatment of refractory epilepsy: report of the Therapeutics and Technology Assessment Subcommittee and Quality Standards Subcommittee of the American Academy of Neurology and the American Epilepsy Society. Neurology 2004;62:1261-1273 (Pubitemid 38526036)
6. Glauser TBME, Bourgeois B, Cnaan A, et al. ILAE treatment guidelines: evidence-based analysis of antiepileptic drug efficacy and effectiveness as initial monotherapy for epileptic seizures and syndromes. Epilepsia 2006;47:1094-1120 (Pubitemid 44086745)
7. Health USNIo: ClinicalTrials.gov. Edited by; 2008
8. Benes J, Parada A, Figueiredo AA, et al. Anticonvulsant and sodium channel-blocking properties of novel 10,11- dihydro-5H-dibenz[b,f ]azepine- 5-carboxamide derivatives. J Med Chem 1999;42:2582-2587 (Pubitemid 29344298)
9. Hainzl D, Parada A, Soares-da-Silva P. Metabolism of two new antiepileptic drugs and their principal metabolites S(+)- and R(-)-10,11-dihydro-10-hydroxy carbamazepine. Epilepsy Res 2001;44:197-206 (Pubitemid 32452229)
10. Volosov A, Xiaodong S, Perucca E, et al. Enantioselective pharmacokinetics of 10-hydroxycarbazepine after oral administration of oxcarbazepine to healthy Chinese subjects. Clin Pharmacol Ther 1999;66:547-553 (Pubitemid 30014079)
11. Alves G, Figueiredo I, Falcao A, et al. Stereoselective disposition of S- and R-licarbazepine in mice. Chirality 2008 .In press (Pubitemid 351961769)
12. Ambrosio AF, Silva AP, Malva JO, et al. Inhibition of glutamate release by BIA 2-093 and BIA 2-024, two novel derivatives of carbamazepine, due to blockade of sodium but not calcium channels. Biochem Pharmacol 2001;61:1271-1275 (Pubitemid 32375119)
13. Bonifacio MJ, Sheridan RD, Parada A, et al. Interaction of the novel anticonvulsant, BIA 2-093, with voltage-gated sodium channels: comparison with carbamazepine. Epilepsia 2001;42:600-608 (Pubitemid 32453642)
14. Almeida L, Soares-da-Silva P. Eslicarbazepine acetate (BIA 2-093). Neurother 2007;4:88-96 (Pubitemid 46107316)
15. Parada A, Soares-da-Silva P. The novel anticonvulsant BIA 2-093 inhibits transmitter release during opening of voltage-gated sodium channels: a comparison with carbamazepine and oxcarbazepine. Neurochem Int 2002;40:435-440 (Pubitemid 34121989)
16. Almeida L, Potgieter JH, Maia J, et al. Pharmacokinetics of eslicarbazepine acetate in patients with moderate hepatic impairment. Eur J Clin Pharmacol 2008;64:267-273
17. Maia J, Vaz-da-Silva M, Almeida L, et al. Effect of food on the pharmacokinetic profile of eslicarbazepine acetate (BIA 2-093). Drugs R D 2005;6:201-206 (Pubitemid 40994241)
18. Almeida L, Soares-da-Silva P. Safety, tolerability and pharmacokinetic profile of BIA 2-093, a novel putative antiepileptic agent, during first administration to humans. Drugs R D 2003;4:269-284 (Pubitemid 37184388)
19. BIAL: unpublished results. Edited by: BIAL- Portela & co.; 2008
20. Vaz-da-Silva M, Nunes T, Soares E, et al. Eslicarbazepine acetate pharmacokinetics after single and repeated doses in healthy subjects [abstract]. Epilepsia 2005;46:191
21. Maia J, Almeida L, Falcao A, et al. Effect of renal impairment on the pharmacokinetics of eslicarbazepine acetate. Int J Clin Pharmacol Ther 2008;46:119-130 (Pubitemid 351721154)
22. Almeida L, Falcao A, Maia J, et al. Single-dose and steady-state pharmacokinetics of eslicarbazepine acetate (BIA 2-093) in healthy elderly and young subjects. J Clin Pharmacol 2005;45:1062-1066 (Pubitemid 41192366)
23. Falcao A, Maia J, Almeida L, et al. Effect of gender on the pharmacokinetics of eslicarbazepine acetate (BIA 2-093), a new voltage-gated sodium channel blocker. Biopharm Drug Dispos 2007;28:249-256 (Pubitemid 47180174)
24. Almeida L, Minciu I, Nunes T, et al. Pharmacokinetics, efficacy, and tolerability of eslicarbazepine acetate in children and adolescents with epilepsy. J Clin Pharmacol 2008;48:966-977 (Pubitemid 352009492)
25. Almeida L, Potgieter JH, Maia J, et al. Pharmacokinetics of eslicarbazepine acetate in patients with moderate hepatic impairment. Eur J Clin Pharmacol 2008;64:267-273
26. Bialer M, Johannessen SI, Kupferberg HJ, et al. Progress report on new antiepileptic drugs: a summary of the Eigth Eilat Conference (EILAT VIII). Epilepsy Res 2007;73:1-52 (Pubitemid 46091734)
27. Bialer MFA, Maia J, Almeida L, Soares-da-Silva P. Investigation of the influence of eslicarbazepine acetate on the plasma concentrations of concomitant antiepileptic drugs in patients with partial epilepsy. In 8th European Congress on Epileptology; Berlim: 2008
28. Nunes T, Maia J, Almeida L, Soares-da-Silva P. Pharmacokinetic interaction between eslicarbazepine acetate and lamotrigine in healthy subjects [abstract book]. Proceedings of the Annual Meeting of the American Epilepsy Society, Philadelphia; 2007
29. Almeida L, Vaz-da-Silva M, Falcão A, et al. Effect of eslicarbazepine acetate (BIA 2-093) on the steady-state pharmacokinetics and pharmacodynamics of warfarin in healthy subjects [abstract book]. Proceedings of the 7th European Congress on Epileptology; Helsinki: 2006
30. Maia J, Almeida L, Vaz-da-Silva M, et al. Effect of eslicarbazepine acetate on the steady-state pharmacokinetics of digoxin in healthy subjects [abstract]. Epilepsia 2005;46:178-179
31. Almeida L, Bialer M, Soares-da-Silva P. Eslicarbazepine Acetate.Third edition. In: Shorvon S, Perucca E, Engel J, editors, The Treatment of Epilepsy. Blackwell Publishing, 2008; In press
32. Elger C, Bialer M, Cramer JA, et al. Eslicarbazepine acetate: a double-blind, add-on, placebo-controlled exploratory trial in adult patients with partial-onset seizures. Epilepsia 2007;48:497-504 (Pubitemid 46365199)
33. Elger CHP, Maia J, Almeida L, Soares-da-Silva P. on behalf of the BIA-2093-301 Study Group: Efficacy and safety of eslicarbazepine acetate as add-on treatment in adults with refractory partial-onset seizures: BIA-2093-301 Study. In 8th European Congress on Epileptology; Berlim: 2008
34. Hufnagel ABME, Gabbai AA, Maia J, et al. on behalf of the BIA-2093-302 Study Group: Efficacy and safety of eslicarbazepine acetate as add-on treatment in adults with refractory partial-onset seizures: BIA-2093-302 Study. In 8th European Congress on Epileptology; Berlim: 2008
35. Lopes-Lima JGNA, Maia J, Almeida L, Soares-da-Silva P. on behalf of the BIA-2093-303 Study Group: Efficacy and safety of eslicarbazepine acetate as add-on treatment in adults with refractory partial-onset seizures: BIA-2093-303 Study. In 8th European Congress on Epileptology; Berlim: 2008
36. Guekht AEC, Halász P, Maia J, et al. on behalf of the BIA-2093-301 Study Group: Long-term treatment of partial epilepsy with eslicarbazepine acetate: results of a 1-year open-label extension study. In 8th European Congress on Epileptology; Berlim: 2008
37. Cramer JMJ, Almeida L, Soares-da-Silva P. Quality-of-life improvement during long-term treatment with eslicarbazepine acetate. In 8th European Congress on Epileptology; Berlim: 2008
38. Hodoba DCA, Cramer J, Maia J, et al. Depressive symptoms improvement during long-term treatment with eslicarbazepine acetate. In 8th European Congress on Epileptology; Berlim: 2008
39. Amelsvoort THBR, Devaux CB, Schwabe S. Hyponatremia Associated with Carbamazepine and Oxcarbazepine Therapy: A Review. Epilepsia 1994;35:181-188 (Pubitemid 24074484)
40. Marson AG, Al-Kharusi AM, Alwaidh M, et al. The SANAD study of effectiveness of carbamazepine, gabapentin, lamotrigine, oxcarbazepine, or topiramate for treatment of partial epilepsy: an unblinded randomised controlled trial. Lancet 2007;369:1000-1015 (Pubitemid 46436124)
41. Almeida LNT, Gutierrez MJ, Litwin J, Soares-da-Silva P. A randomized, double-blind, placebo- and moxifloxacin-controlled, 4 period crossover trial to evaluate the effect of eslicarbazepine acetate on cardiac repolarization in healthy subjects. In 8th European Congress on Epileptology; Berlim: 2008