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Last Updated: January 15, 2025

Claims for Patent: 11,654,133


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Summary for Patent: 11,654,133
Title:Use of [(1R)-1-(2-chlorophenyl)-2-(tetrazol-2-yl)ethyl] carbamate in combination therapy
Abstract:The present disclosure provides combination therapy using [(1R)-1-(2-chlorophenyl)-2-(tetrazol-2-yl)ethyl] carbamate (cenobamate) and one or more antiepileptic drugs for the prevention or treatment of a neurological disorder such as epilepsy.
Inventor(s):Marc Kamin, Laurent VERNILLET
Assignee:SK Biopharmaceuticals Co Ltd, Yahoo AD Tech LLC
Application Number:US17/037,932
Patent Claims: 1. A method for treating a patient who is suffering from epilepsy with co-administering a therapeutically effective amount of (i) [(1R)-1-(2-chlorophenyl)-2-(tetrazol-2-yl)ethyl] carbamate (cenobamate) or a pharmaceutically acceptable salt thereof and (ii) one or two antiepileptic drugs, said method comprising: modifying the therapeutically effective amount of the antiepileptic drug to adjust AUC of the antiepileptic drug obtained after the co-administration having at least 5% difference to the level of AUC obtained after the administration of antiepileptic drug to the patient without cenobamate or a pharmaceutically acceptable salt thereof, wherein the therapeutically effective amount of cenobamate or a pharmaceutically acceptable salt thereof is from about 100 mg/day to about 400 mg/day, and wherein the antiepileptic drug is selected from the group consisting of phenobarbital and phenytoin.

2. The method according to claim 1, wherein the therapeutically effective amount of cenobamate is achieved by the following titration method: (1) administering cenobamate to the patient about 12.5 mg once daily for about two weeks; (2) then administering cenobamate to the patient about 25 mg once daily for two weeks; (3) then administering cenobamate to the patient about 50 mg once daily for about two weeks; and (4) then increasing the dose in about bi-weekly increments by no more than about 50 mg once daily to a therapeutically effective amount.

3. The method according to claim 1, wherein the therapeutically effective amount of cenobamate is achieved by the following titration method: (1) administering cenobamate to the patient about 50 mg once daily for about two weeks; and (2) then increasing the dose in about bi-weekly increments by about 50 mg once daily to about 200 mg/day once daily, wherein cenobamate is administered for about 6 weeks and the therapeutically effective amount of cenobamate is about 200 mg/day.

4. The method according to claim 1, wherein the therapeutically effective amount of cenobamate is achieved by the following titration method: (1) administering cenobamate to the patient about 50 mg once daily which is increased with 50 mg once daily per week to about 100 mg/day; (2) optionally increasing the dose in about weekly increments by about 50 mg once daily per week to about 200 mg/day; and (3) optionally increasing the dose in about weekly increments by about 100 mg/day per week to about 400 mg/day, wherein cenobamate is administered for about 2 weeks, 4 weeks, or 6 weeks depending on therapeutically effective amount of cenobamate which is required and the therapeutically effective amount of cenobamate is about 100 mg/day, about 200 mg/day or about 400 mg/day.

5. The method according to claim 1, wherein the antiepileptic drug is phenobarbital.

6. The method according to claim 5, wherein the therapeutically effective amount of phenobarbital is decreased by about 20% to about 50% by weight compared to a therapeutically effective amount of the patient in case of its monotherapy.

7. The method according to claim 6, wherein the therapeutically effective amount of phenobarbital is decreased by about 25% to about 45% by weight compared to a therapeutically effective amount of the patient in case of its monotherapy.

8. The method according to claim 5, wherein the therapeutically effective amount of phenobarbital is decreased to adjust about 20% to about 50% increase in AUC of phenobarbital obtained after the co-administration to the level of AUC obtained after the administration of phenobarbital to the patient without cenobamate.

9. The method according to claim 8, wherein the therapeutically effective amount of phenobarbital is decreased to adjust about 25% to about 45% increase in AUC of phenobarbital obtained after the co-administration to the level of AUC obtained after the administration of phenobarbital to the patient without cenobamate.

10. The method according to claim 1, wherein the antiepileptic drug is phenytoin.

11. The method according to claim 10, wherein the therapeutically effective amount of phenytoin is decreased by about 7% to about 55% by weight compared to a therapeutically effective amount of the patient in case of its monotherapy.

12. The method according to claim 11, wherein the therapeutically effective amount of phenytoin is decreased by about 10% to about 40% by weight compared to a therapeutically effective amount of the patient in case of its monotherapy.

13. The method according to claim 10, wherein the therapeutically effective amount of phenytoin is decreased to adjust about 10% to about 100% increase in AUC of phenytoin obtained after the co-administration to the level of AUC obtained after the administration of phenytoin to the patient without cenobamate.

14. The method according to claim 13, wherein the therapeutically effective amount of phenytoin is decreased to adjust about 10% to about 60% increase in AUC of phenytoin obtained after the co-administration to the level of AUC obtained after the administration of phenytoin to the patient without cenobamate.

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