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Claims for Patent: 8,114,909

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Claims for Patent: 8,114,909

Title:Treating or preventing restless legs syndrome using prodrugs of GABA analogs
Abstract: Disclosed herein are methods of using prodrugs of gamma aminobutyric acid (GABA) analogs and pharmaceutical compositions thereof to treat or prevent restless legs syndrome in humans, and pharmaceutical compositions of prodrugs of GABA analogs useful in treating or preventing restless legs syndrome.
Inventor(s): Barrett; Ronald W. (Saratoga, CA), Canafax; Daniel M. (Half Moon Bay, CA)
Assignee: XenoPort, Inc. (Santa Clara, CA)
Application Number:10/969,196
Patent Claims: 1. A method of treating restless legs syndrome in a patient, comprising orally administering to the patient in need of such treatment a sustained release dosage form containing a therapeutically effective amount of 1-{[(.alpha.-isobutanoyloxyethoxy)carbonyl]-aminomethyl}-1-cyclohexane acetic acid or a pharmaceutically acceptable salt, hydrate or solvate thereof.

2. A method of improving sleep in a patient with restless legs syndrome, comprising orally administering to the patient in need of such treatment a sustained release dosage form containing a therapeutically effective amount of 1-{[(.alpha.-isobutanoyloxyethoxy)carbonyl]-aminomethyl}-1-cycl- ohexane acetic acid or a pharmaceutically acceptable salt, hydrate or solvate thereof.

3. The method of claim 1, wherein the restless legs syndrome is idiopathic.

4. The method of claim 1, wherein the restless legs syndrome is secondary to a medical condition.

5. The method of claim 4, wherein the medical condition is iron deficiency.

6. The method of claim 4, wherein the medical condition requires dialysis.

7. The method of claim 1, wherein the patient suffers symptoms of restless legs syndrome while awake and inactive.

8. The method of claim 1, wherein the patient suffers symptoms of restless legs syndrome while asleep.

9. The method of claim 1, wherein the dosage form provides a therapeutic concentration of 1-(aminomethyl)cyclohexane acetic acid in the plasma of the patient for a period of at least about 6 hours.

10. The method of claim 1, wherein the dosage form comprises an osmotic dosage form, a prodrug-releasing polymer, a prodrug-releasing lipid, a prodrug-releasing wax, tiny timed-release pills or prodrug releasing beads.

11. The method of claim 1, wherein the 1-{[(.alpha.-isobutanoyloxyethoxy)carbonyl]-aminomethyl}-1-cyclohexane acetic acid or a pharmaceutically acceptable salt, hydrate or solvate thereof is 1-{[(.alpha.-isobutanoyloxyethoxy)carbonyl]aminomethyl}-1-cyclohexane acetic acid.

12. The method of claim 1, wherein the 1-{[(.alpha.-isobutanoyloxyethoxy)carbonyl]-aminomethyl}-1 -cyclohexane acetic acid or a pharmaceutically acceptable salt, hydrate or solvate thereof is 1-{[(.alpha.-isobutanoyloxyethoxy)carbonyl]-aminomethyl}-1-cyclohexane acetic acid or a pharmaceutically acceptable salt thereof.

13. The method of claim 1, wherein the sustained release oral dosage form is administered in an amount of about 600 mg/dose.

14. The method of claim 13, wherein the dose is administered during the evening.

15. A method of treating restless legs syndrome in a patient, comprising orally administering to the patient in need of such treatment a sustained release dosage form containing a therapeutically effective amount of 1-{[(.alpha.-isobutanoyloxyethoxy)carbonyl]-aminomethyl}-1-cyclohexane acetic acid or a pharmaceutically acceptable salt, hydrate or solvate thereof in an amount of between 100 mg/dose to 1000 mg/dose with up to 4 doses administered per day.

16. A method of improving sleep in a patient with restless legs syndrome, comprising orally administering to the patient in need of such treatment a sustained release dosage form containing a therapeutically effective amount of 1-{[(.alpha.-isobutanoyloxyethoxy)carbonyl]-aminomethyl}-1-cycl- ohexane acetic acid or a pharmaceutically acceptable salt, hydrate or solvate thereof in an amount of between 100 mg/dose to 1000 mg/dose with up to 4 doses administered per day.

17. The method of claim 15, wherein the restless legs syndrome is idiopathic.

18. The method of claim 15, wherein the restless legs syndrome is secondary to a medical condition.

19. The method of claim 18, wherein the medical condition is iron deficiency.

20. The method of claim 18, wherein the medical condition requires dialysis.

21. The method of claim 15, wherein the patient suffers symptoms of restless legs syndrome while awake and inactive.

22. The method of claim 15, wherein the patient suffers symptoms of restless legs syndrome while asleep.

23. The method of claim 15, wherein the dosage form provides a therapeutic concentration of 1-(aminomethyl)cyclohexane acetic acid in the plasma of the patient for a period of at least about 6 hours.

24. The method of claim 15, wherein the dosage form comprises an osmotic dosage form, a prodrug-releasing polymer, a prodrug-releasing lipid, a prodrug-releasing wax, tiny timed-release pills or prodrug releasing beads.

25. The method of claim 15, wherein the 1-{[(.alpha.-isobutanoyloxyethoxy)carbonyl]-aminomethyl}-1-cyclohexane acetic acid or a pharmaceutically acceptable salt, hydrate or solvate thereof is 1-{[(.alpha.-isobutanoyloxyethoxy)carbonyl]-aminomethyl}-1-cyclohexane acetic acid.

26. The method of claim 15, wherein the 1-{[(.alpha.-isobutanoyloxyethoxy)carbonyl]-aminomethyl}-1-cyclohexane acetic acid or a pharmaceutically acceptable salt, hydrate or solvate thereof is 1-{[(.alpha.-isobutanoyloxyethoxy)carbonyl]-aminomethyl}-1-cyclohexane acetic acid or a pharmaceutically acceptable salt thereof.

27. The method of claim 15, wherein a dose is about 600 mg.

28. The method of claim 27, wherein the dose is administered during the evening.

29. The method of claim 2, wherein the restless legs syndrome is idiopathic.

30. The method of claim 2, wherein the restless legs syndrome is secondary to a medical condition.

31. The method of claim 30, wherein the medical condition is iron deficiency.

32. The method of claim 30, wherein the medical condition requires dialysis.

33. The method of claim 2, wherein the patient suffers symptoms of restless legs syndrome while awake and inactive.

34. The method of claim 2, wherein the patient suffers symptoms of restless legs syndrome while asleep.

35. The method of claim 2, wherein the dosage form provides a therapeutic concentration of 1-(aminomethyl)cyclohexane acetic acid in the plasma of the patient for a period of at least about 6 hours.

36. The method of claim 2, wherein the dosage form comprises an osmotic dosage form, a prodrug-releasing polymer, a prodrug-releasing lipid, a prodrug-releasing wax, tiny timed-release pills or prodrug releasing beads.

37. The method of claim 2, wherein the 1-{[(.alpha.-isobutanoyloxyethoxy)carbonyl]-aminomethyl}-1-cyclohexane acetic acid or a pharmaceutically acceptable salt, hydrate or solvate thereof is 1-{[(.alpha.-isobutanoyloxyethoxy)carbonyl]-aminomethyl}-1-cyclohexane acetic acid.

38. The method of claim 2, wherein the 1-{[(.alpha.-isobutanoyloxyethoxy)carbonyl]-aminomethyl}-1-cyclohexane acetic acid or a pharmaceutically acceptable salt, hydrate or solvate thereof is 1-{[(.alpha.-isobutarioyloxyethoxy)carbonyl]-aminomethyl}-1-cyclohexane acetic acid or a pharmaceutically acceptable salt thereof.

39. The method of claim 2, wherein the sustained release oral dosage form is administered in an amount of about 600 mg/dose.

40. The method of claim 39, wherein the dose is administered during the evening.

41. The method of claim 16, wherein the restless legs syndrome is idiopathic.

42. The method of claim 16, wherein the restless legs syndrome is secondary to a medical condition.

43. The method of claim 42, wherein the medical condition is iron deficiency.

44. The method of claim 42, wherein the medical condition requires dialysis.

45. The method of claim 16, wherein the patient suffers symptoms of restless legs syndrome while awake and inactive.

46. The method of claim 16, wherein the patient suffers symptoms of restless legs syndrome while asleep.

47. The method of claim 16, wherein the dosage form provides a therapeutic concentration of 1-(aminomethyl)cyclohexane acetic acid in the plasma of the patient for a period of at least about 6 hours.

48. The method of claim 16, wherein the dosage form comprises an osmotic dosage form, a prodrug-releasing polymer, a prodrug-releasing lipid, a prodrug-releasing wax, tiny timed-release pills or prodrug releasing beads.

49. The method of claim 16, wherein the 1-{[(.alpha.-isobutanoyloxyethoxy)carbonyl]-aminomethyl}-1-cyclohexane acetic acid or a pharmaceutically acceptable salt, hydrate or solvate thereof is 1-{[(.alpha.-isobutarioyloxyethoxy)carbonyl]-aminomethyl}-1-cyclohexane acetic acid.

50. The method of claim 16, wherein the 1-{[(.alpha.-isobutanoyloxyethoxy)carbonyl]-aminomethyl}-1-cyclohexane acetic acid or a pharmaceutically acceptable salt, hydrate or solvate thereof is 1-{[(.alpha.-isobutarioyloxyethoxy)carbonyl]-aminomethyl}-1-cyclohexane acetic acid or a pharmaceutically acceptable salt thereof.

51. The method of claim 16, wherein a dose is about 600 mg.

52. The method of claim 51, wherein the dose is administered during the evening.
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