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Claims for Patent: 5,872,145

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Claims for Patent: 5,872,145

Title: Formulation of 5-HT agonist and NSAID for treatment of migraine
Abstract:This invention comprises a method of treating migraine in a human comprising co-timely administering of a therapeutically effective amount of a 5-HT agonist coordinated with a therapeutically effective amount of an analgesic, particularly a long-acting NSAID in doses below those ordinarily considered as minimum effective doses as to both 5-HT agonist and long-acting NSAID. Dosage forms are also included herein.
Inventor(s): Plachetka; John R. (Chapel Hill, NC)
Assignee: Pozen, Inc. (Chapel Hill, NC)
Application Number:08/907,826
Patent Claims: 1. A method of treating migraine in a human comprising co-timely administering of a therapeutically effective amount of a 5-HT agonist coordinated with a therapeutically effective amount of an NSAID or non-NSAID analgesic, wherein said therapeutically effective amounts are sub-MED amounts.

2. The method of claim 1 wherein the NSAID is a long-acting NSAID.

3. The method of claim 1 wherein the 5-HT agonist is sumatriptan.

4. The method of claim 3 wherein the 5-HT agonist is sumatriptan non-parenterally administered in an amount of from about 1 to about 15 mg.

5. The method of claim 4 wherein administering is orally, intranasally, rectally or sublingually.

6. The method of claim 3 wherein sumatriptan administering is parenterally from about 1 to about 4 mg.

7. The method of claim 6 wherein administering is by subcutaneous injecting.

8. The method of claim 2 wherein the NSAID is naproxen, or pharmaceutically acceptable salt thereof.

9. The method of claim 3 wherein the NSAID is naproxen, or pharmaceutically acceptable salt thereof.

10. The method of claim 9 wherein the naproxen or pharmaceutically acceptable salt thereof is administered to a human in an amount of about 200 mg or less.

11. The method of claim 10 wherein the naproxen is administered to a human in an amount of from about 100 mg to about 200 mg.

12. The method of claim 9 wherein the naproxen is naproxen sodium.

13. The method of claim 12 wherein the naproxen is administered to a human in an amount of from about 100 mg to about 200 mg.

14. The method of claim 13 wherein the naproxen is administered in an amount of from about 100 to about 125 mg.

15. The method of claim 1 wherein the 5-HT agonist and the NSAID or non-NSAID analgesic are administered simultaneously.

16. The method of claim 1 wherein said administration is in a unit dosage form.

17. The method of claim 16 wherein the unit dosage form is a "quick dissolve" tablet.

18. The method of claim 17 wherein the 5-HT agonist is sumatriptan, the NSAID is naproxen and the unit dosage form is an oral unit dosage form comprising sumatriptan in an amount of about 15 mg or less, and naproxen in an amount of about 200 mg or less.

19. The method of claim 2 further comprising co-timely and coordinated administering of a therapeutically effective amount of at least one additional analgesic in sub-MED amount.

20. The method of claim 19 wherein the additional analgesic is ibuprofen.

21. The method of claim 20 wherein the additional analgesic is a non-NSAID analgesic.

22. The method of claim 21 wherein the additional analgesic is acetaminophen.

23. The method of claim 1 wherein the NSAID is ibuprofen.

24. The method of claim 1 wherein the non-NSAID analgesic is acetaminophen.

25. A co-timely delivery, coordinated unit dosage form comprising a therapeutically effective amount of a 5-HT agonist and a therapeutically effective amount of an NSAID or non-NSAID analgesic, wherein said therapeutically effective amounts are sub-MED amounts.

26. The unit dosage form of claim 25 wherein the NSAID is ibuprofen.

27. The unit dosage form of claim 25 wherein the NSAID is a long-acting NSAID.

28. The unit dosage form of claim 25 wherein the 5-HT agonist is sumatriptan.

29. The unit dosage form of claim 28 comprising a non-parenteral unit dosage form comprising sumatriptan in an amount of about 15 mg or less.

30. The unit dosage form of claim 29 wherein the amount of sumatriptan is about 1 to about 10 mg.

31. The unit dosage form of claim 27 wherein the NSAID is naproxen, or pharmaceutically acceptable salt thereof.

32. The unit dosage form of claim 31 comprising an oral unit dosage form comprising naproxen, or pharmaceutically acceptable salt thereof in an amount of about 200 mg or less.

33. The unit dosage form of claim 32 comprising naproxen or pharmaceutically acceptable salt thereof in an amount of from about 100 to about 200 mg.

34. The unit dosage form of claim 28 wherein the NSAID is naproxen or pharmaceutically acceptable salt thereof.

35. The unit dosage form of claim 34 comprising naproxen, or pharmaceutically acceptable salt thereof in an amount of from about 100 mg to about 200 mg.

36. The unit dosage form of claim 35 comprising naproxen or pharmaceutically acceptable salt thereof in an amount of from about 100 to about 125 mg.

37. The unit dosage form of claim 36 wherein the naproxen is naproxen sodium.

38. The unit dosage form of claim 29 wherein the 5-HT agonist is sumatriptan, the NSAID is naproxen and the unit dosage form comprises an oral unit dosage form of about 15 mg sumatriptan, and about 200 mg or less naproxen.

39. The unit dosage form of claim 25 wherein the non-NSAID analgesic is acetaminophen.

40. The method of claim 1 wherein the 5-HT agonist is a 5-HT agonist that is not an ergot alkaloid.

41. The unit dosage form of claim 25 wherein the 5-HT agonist is a 5-HT agonist that is not an ergot alkaloid.

42. The unit dosage form of claim 33 comprising naproxen or pharmaceutically acceptable salt thereof in an amount of from about 100 to about 125 mg.

43. A method of treating migraine in a human comprising co-timely non-parenterally administering sumatriptan in an amount of about from about 1 mg to about 15 mg coordinated with a non-parenterally administering naproxen or pharmaceutically acceptable salt thereof in an amount of about 200 mg or less.

44. The method of claim 43 where in the naproxen or pharmaceutically acceptable salt thereof is in an amount of from about 100 to about 200 mg.

45. The method of claim 44 wherein the sumatriptan is in an amount of about 1 to about 10 mg.

46. A non-parenteral unit dosage form comprising sumatriptan in an amount of about 15 mg or less and naproxen, or pharmaceutically acceptable salt thereof, in an amount of 200 mg or less.

47. The non-parenteral unit dosage form of claim 46 wherein said sumatriptan is present in an amount of from about 1 to about about 15 mg and said naproxen, or pharmaceutically acceptable salt thereof, is in an amount of from about 100 mg to about 200 mg.

48. The non-parenteral unit dosage form of claim 47 wherein said sumatriptan is in an amount of from about 1 mg to about 10 mg.

49. The non-parenteral unit dosage form of claim 46 wherein said naproxen or pharmaceutically acceptable salt thereof is naproxen sodium.

50. The non-parenteral unit dosage form of claim 47 wherein said naproxen or pharmaceutically acceptable salt thereof is naproxen sodium.

51. The non-parenteral unit dosage form of claim 48 wherein said naproxen or pharmaceutically acceptable salt thereof is naproxen sodium.

52. The non-parenteral unit dosage form of claim 46 wherein said sumatriptan is in an amount of from about 1 to about 10 mg.

53. The non-parenteral unit dosage form of claim 47 wherein said sumatriptan is in an amount of from about 5 to about 10 mg.

54. The non-parenteral unit dosage form of claim 46 wherein said form is an oral unit dosage form.

55. The non-parenteral unit dosage form of claim 47 wherein said form is an oral unit dosage form.

56. The non-parenteral unit dosage form of claim 50 wherein said form is an oral unit dosage form.

57. The non-parenteral unit dosage form of claim 51 wherein said form is an oral unit dosage form.

58. The unit dosage form of claim 54 wherein said form is a "quick dissolve" tablet.

59. The unit dosage form of claim 55 wherein said form is a "quick dissolve" tablet.

60. The unit dosage form of claim 56 wherein said form is a "quick dissolve" tablet.

61. The unit dosage form of claim 57 wherein said form is a "quick dissolve" tablet.
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