IP Library Granted Patent US 6,977,253
Granted Patent B2
US 6,977,253 · App. 10/848,383 · Granted Dec 20, 2005

Methods for the treatment of bipolar disorder using carbamazepine

Assignee: Shire Pharmaceutical Development Inc.
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Quick Facts
Patent No.
US 6,977,253
App. No.
10/848,383
Granted
Dec 20, 2005
Kind
B2
Abstract

Carbamazepine, in extended release form, is useful in the treatment of patients suffering from bipolar disorder. In order to minimize the time it takes to reach efficacy, carbamazepine, in extended release form, can be administered to the patient at an initial daily dose which is then increased in daily increments until clinical efficacy is achieved.

Claims (34)

1. A method of treating a patient suffering from bipolar disorder comprising administering to said patient an initial daily dose of 100–800 mg of carbamazepine in extended release form and increasing said dose by daily increments of 100–400 mg until clinical efficacy is achieved, wherein the occurrence of adverse side effects is not greater than that which occurs when the daily dose is increased in weekly increments.

2. A method of treating a patient suffering from bipolar disorder comprising administering to said patient an initial daily dose of 100–800 mg carbamazepine in extended release form and increasing said daily dose by daily increments of 100–400 mg until clinical efficacy is achieved.

3. A method according to claim 2 , wherein said method is used to treat a patient that suffers from manic episodes.

4. A method according to claim 2 , wherein said method is used to treat a patient that suffers from mixed episodes.

5. A method according to claim 2 , wherein carbamazepine is administered twice daily.

6. A method according to claim 2 , wherein said initial dose is 200 mg.

7. A method according to claim 2 , wherein said initial dose is 400 mg.

8. A method according to claim 2 , wherein said initial dose is 600 mg.

9. A method according to claim 2 , wherein said initial dose is 800 mg.

10. A method according to claim 2 , wherein the daily dose increment is 100 mg.

11. A method according to claim 2 , wherein the daily dose increment is 200 mg.

12. A method according to claim 2 , wherein the daily dose increment is 300 mg.

13. A method according to claim 2 , wherein the daily dose increment is 400 mg.

14. A method according to claim 2 , further comprising administering to said patient lithium, valproate, chlorpromazine, olanzapine, lamotrigine, gabapentin or a combination thereof.

15. A method according to claim 1 , wherein the period of time during which the daily dose is increased daily by increments is at least 6 days.

16. A method according to claim 1 , further comprising continuing to treat said patient by administering the same daily dose as at which clinically efficacy is achieved or reducing said daily dose by daily increments to a lower level at which efficacy can be maintained.

17. A method according to claim 2 , wherein the period of time during which the daily dose is increased by daily increments is at least 6 days.

18. A method according to claim 2 , further comprising continuing to treat said patient by administering the same daily dose as at which clinically efficacy is achieved or reducing said daily dose by daily increments to a lower level at which efficacy can be maintained.

19. A method of treating a patient suffering from bipolar disorder comprising administering to said patient an initial daily dose of 100–800 mg of carbamazepine in extended release form and increasing said dose by daily increments until a final daily dose of 1,000–1,600 mg.

20. A method according to claim 19 , wherein said initial daily dose is 100–400 mg.

21. A method according to claim 19 , wherein said final daily dose is 1,200–1,600 mg.

22. A method according to claim 21 , wherein said final daily dose is 1,200–1,400 mg.

23. A method according to claim 19 , wherein said initial daily dose is 200 mg.

24. A method according to claim 21 , wherein said initial daily dose is 200 mg.

25. A method according to claim 22 , wherein said initial daily dose is 200 mg.

26. A method according to claim 19 , wherein said initial daily dose is 400 mg.

27. A method according to claim 21 , wherein said initial daily dose is 400 mg.

28. A method according to claim 22 , wherein said initial daily dose is 400 mg.

29. A method according to claim 1 , wherein the period of time during which the daily dose is increased by daily increments is at least 5 days.

30. A method according to claim 2 , wherein the period of time during which the daily dose is increased by daily increments is at least 5 days.

31. A method according to claim 19 , wherein the period of time during which the daily dose is increased by daily increments is at least 5 days.

32. A method according to claim 1 , wherein carbamazepine is administered twice daily, the initial daily dose is 400 mg, and the daily dose increment is 200 mg.

33. A method according to claim 2 , wherein carbamazepine is administered twice daily, the initial daily dose is 400 mg, and the daily dose increment is 200 mg.

34. A method according to claim 19 , wherein carbamazepine is administered twice daily, the initial daily dose is 400 mg, and the daily dose increment is 200 mg.

Assignments (7)
RELEASE OF SECURITY INTEREST Recorded Jul 14, 2020
From: PACIFIC WESTERN BANK
To: VALIDUS PHARMACEUTICALS LLC
Reel/Frame 053202/0585 →
SECURITY AGREEMENT Recorded May 18, 2011
From: VALIDUS PHARMACEUTICALS LLC
To: SQUARE 1 BANK
Reel/Frame 026299/0447 →
RELEASE OF SECURITY INTEREST Recorded Dec 16, 2009
From: HOFFMANN-LA ROCHE ROCHE INC.
To: VALIDUS PHARMACEUTICALS LLC
Reel/Frame 023660/0851 →
MERGER Recorded Jan 14, 2009
From: VALIDUS PHARMACEUTIALS, INC.; FONTUS PHARMACEUTICALS, INC., CORPORATION - STATE OF DELAWARE
To: VALIDUS PHARMACEUTICALS LLC
Reel/Frame 022109/0087 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 25, 2007
From: SHIRE PHARMACEUTICALS DEVELOPMENT INC.
To: SHIRE LLC
Reel/Frame 019872/0142 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 25, 2007
From: SHIRE LLC
To: VALIDUS PHARMACEUTICALS, INC.
Reel/Frame 019872/0162 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 19, 2004
From: KALALI, AMIR H.; TULLOCH, SIMON J.
To: SHIRE PHARMACEUTICAL DEVELOPMENT INC.
Reel/Frame 015353/0069 →
Continuity (2)
Provisional Application 6052729800 · Dec 8, 2003
Related Publication 20050124601A1 · Jun 9, 2005