IP Library Granted Patent US 10,695,354
Granted Patent B2
US 10,695,354 · App. 16/449,057 · Granted Jun 30, 2020

Methods of treatment of partial onset seizures using eslicarbazepine acetate

Inventors: José Luís de Almeida (Arouca, PT); Patrício Manuel Vieira Araújo Soares da Silva (Oporto, PT)
Assignee: Bial-Portela & CA S.A.
A61K31/55A61K31/19A61K45/06
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Quick Facts
Patent No.
US 10,695,354
App. No.
16/449,057
Granted
Jun 30, 2020
Kind
B2
Abstract

The present disclosure relates to the treatment of various diseases and conditions with eslicarbazepine acetate. The present disclosure also relates to the use of eslicarbazepine acetate in a method for reducing or decreasing epileptic seizures in a patient. The present disclosure also relates to a method for increasing the exposure to eslicarbazepine in a patient. The present disclosure also relates to a method of preparing a pharmaceutical composition comprising eslicarbazepine acetate.

Claims (27)

1. A method for treating a patient with partial-onset seizures, comprising administering once-daily from about 800 mg to about 1800 mg of eslicarbazepine acetate to the patient, wherein the patient is a human.

2. The method of claim 1 , comprising administering once-daily at least about 1200 mg of eslicarbazepine acetate to the patient.

3. The method of claim 1 , comprising administering once-daily at least about 1600 mg of eslicarbazepine acetate to the patient.

4. The method of claim 1 , comprising administering once-daily from about 800 mg to about 1600 mg of eslicarbazepine acetate to the patient.

5. The method of claim 1 , comprising administering once-daily about 800 mg of eslicarbazepine acetate to the patient.

6. The method of claim 1 , comprising administering once-daily about 1200 mg of eslicarbazepine acetate to the patient.

7. The method of claim 1 , comprising administering once-daily about 1600 mg of eslicarbazepine acetate to the patient.

8. The method of claim 1 , wherein the eslicarbazepine acetate is in the form of one or more tablets or oral suspensions.

9. The method of claim 1 , wherein the eslicarbazepine acetate is administered orally.

10. The method of claim 1 , wherein steady-state plasma concentrations of eslicarbazepine are attained after 4 to 5 days of once-daily administration of the eslicarbazepine acetate.

11. The method of claim 1 , wherein upon once-daily administration of the eslicarbazepine acetate, the number, duration, or frequency of seizures in the patient decreases relative to the number, duration, or frequency of seizures in a patient without treatment.

12. The method of claim 1 , wherein the once-daily administration of the eslicarbazepine acetate results in a mean maximum plasma concentration, C max , of eslicarbazepine from about 18,700 ng/mL to about 47,700 ng/mL.

13. The method of claim 1 , wherein the once-daily administration of the eslicarbazepine acetate results in an area under the concentration curve, AUC 0-τ , of eslicarbazepine from about 268,400 ng·h/mL to about 740,300 ng·h/mL, wherein τ is the dosing interval, which is 24 hours.

14. A method for treating a patient with refractory partial-onset seizures, comprising administering once-daily from about 800 mg to about 1800 mg of eslicarbazepine acetate to the patient, wherein the patient is a human experiencing at least four partial-onset seizures per month in spite of treatment with at least one other antiepileptic drug.

15. The method of claim 14 , wherein the eslicarbazepine acetate is administered once-daily as adjunctive therapy to a patient being treated with at least one other anti-epileptic drug.

16. The method of claim 15 , wherein the at least one other anti-epileptic drug is chosen from phenytoin, valproate, primidone, phenobarbital, lamotrigine, gabapentin, topiramate, clonazepam, and combinations thereof.

17. The method of claim 15 , wherein the serum concentration of the at least one other anti-epileptic drug is not significantly decreased by the once-daily administration of the eslicarbazepine acetate.

18. The method of claim 14 , comprising administering once-daily at least about 1200 mg of eslicarbazepine acetate to the patient.

19. The method of claim 14 , comprising administering once-daily at least about 1600 mg of eslicarbazepine acetate to the patient.

20. The method of claim 14 , comprising administering once-daily from about 800 mg to about 1600 mg of eslicarbazepine acetate to the patient.

21. The method of claim 14 , comprising administering once-daily about 800 mg of eslicarbazepine acetate to the patient.

22. The method of claim 14 , comprising administering once-daily about 1200 mg of eslicarbazepine acetate to the patient.

23. The method of claim 14 , comprising administering once-daily about 1600 mg of eslicarbazepine acetate to the patient.

24. The method of claim 14 , wherein the eslicarbazepine acetate is in the form of one or more tablets or oral suspensions.

25. The method of claim 14 , wherein the eslicarbazepine acetate is administered orally.

26. The method of claim 1 , wherein eslicarbazepine acetate is administered once-daily in an initial dose of about 400 mg and increased to a dose of about 800 mg, about 1200 mg, or about 1600 mg.

27. The method of claim 14 , wherein eslicarbazepine acetate is administered once-daily in an initial dose of about 400 mg and increased to a dose of about 800 mg, about 1200 mg, or about 1600 mg.

Assignments (2)
CHANGE OF NAME Recorded Jun 5, 2020
From: PORTELA & CA, SA
To: BIAL-PORTELA & CA, SA
Reel/Frame 052851/0527 →
CONFIRMATORY COPY OF ASSIGNMENT Recorded Jun 5, 2020
From: ALMEIDA, JOSE LUIS DE; SOARES DA SILVA, PATRICIO MANUEL VIEIRA ARAUJO
To: PORTELA & C.A., S.A
Reel/Frame 052858/0205 →
Continuity (5)
Continuation 15422278 · Feb 1, 2017
Division 14187018 · Feb 21, 2014
Continuation 13017732 · Jan 31, 2011
Continuation 11123205 · May 6, 2005
Related Publication 20190307765A1 · Oct 10, 2019