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Claims for Patent: 8,497,256

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Claims for Patent: 8,497,256

Title:Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives for the treatment of males
Abstract: The instant application provides methods and compositions for the treatment of male subjects having ulcerative colitis.
Inventor(s): Forbes; William (Raleigh, NC), Bortey; Enoch (Chapel Hill, NC), Johnson; Lorin (Palo Alto, CA)
Assignee: Salix Pharmaceuticals, Ltd (Raleigh, NC)
Application Number:13/094,261
Patent Claims: 1. A method for treating a gastrointestinal disorder in a male subject comprising administering to the male subject in need of treatment a therapeutically effective amount of balsalazide.

2. The method claim 1, wherein the therapeutically effective amount comprises about 6.5 to about 6.8 g per day.

3. The method claim 1, wherein the therapeutically effective amount comprises about 6.6 g per day.

4. The method claim 1, wherein the therapeutically effective amount comprises about 6.75 g per day.

5. The method of claim 1, wherein the therapeutically effective amount is a dosage regimen of three tablets of the formulation two times each day, wherein each tablet comprises about 1100 mg of balsalazide.

6. The method of claim 5, wherein the balsalazide tablet is a film-coated tablet.

7. The method of claim 1, wherein the therapeutically effective amount is a dosage regimen of three capsules of the formulation three times each day, wherein each capsule comprises about 750 mg of balsalazide.

8. The method of claim 1, wherein the administration to the subject occurs between about 30 minutes prior to about 1 hour after consuming food.

9. The method of claim 1, wherein the gastrointestinal disorder comprises ulcerative colitis.

10. The method of claim 9, wherein the ulcerative colitis is mild to moderately active ulcerative colitis.

11. A method of decreasing a MMDAI score in a male subject having ulcerative colitis comprising administering to the male subject a therapeutically effective amount of balsalazide, thereby decreasing the MMDAI score.

12. The method claim 11, wherein the therapeutically effective amount comprises between about 6.5 to about 6.8 g per day.

13. The method claim 11, wherein the therapeutically effective amount comprises about 6.6 g per day.

14. The method claim 11, wherein the therapeutically effective amount comprises about 6.75 g per day.

15. The method of claim 12, wherein the therapeutically effective amount is a dosage regimen of three tablets of the formulation two times each day, wherein each tablet comprises about 1100 mg of balsalazide.

16. The method of claim 15, wherein the balsalazide tablet is a film-coated tablet.

17. The method of claim 11, wherein the therapeutically effective amount is a dosage regimen of three capsules of the formulation three times each day, wherein each capsule comprises about 750 mg of balsalazide.

18. The method of claim 11, wherein the MMDAI score is decreased by 3 or more points.

19. The method of claim 11, wherein the rectal bleeding component of the MMDAI score is decreased by 1or more points.

20. A method of inducing clinical remission of ulcerative colitis in a male subject comprising administering to the male subject a therapeutically effective amount of balsalazide, thereby inducing remission in the subject.

21. The method claim 20, wherein the therapeutically effective amount comprises between about 6.5 to about 6.8 g per day.

22. The method claim 20, wherein the therapeutically effective amount comprises about 6.6 g per day.

23. The method claim 20, wherein the therapeutically effective amount comprises about 6.75 g per day.

24. The method of claim 21, wherein the therapeutically effective amount is a dosage regimen of three tablets of the formulation two times each day, wherein each tablet comprises about 1100 mg of balsalazide.

25. The method of claim 24, wherein the balsalazide tablet is a film-coated tablet.

26. The method of claim 20, wherein the therapeutically effective amount is a dosage regimen of three capsules of the formulation three times each day, wherein each capsule comprises about 750 mg of balsalazide.

27. The method of claim 20, wherein remission is defined by MMDAI component scores of zero for rectal bleeding and a combined score of 2 or less for bowel frequency and physician's assessment.

28. A method of inducing mucosal healing in a male subject having ulcerative colitis comprising administering to the male subject a therapeutically effective amount of balsalazide, thereby inducing mucosal healing in the subject.

29. The method claim 28, wherein the therapeutically effective amount comprises between about 6.5 to about 6.8 g per day.

30. The method claim 28, wherein the therapeutically effective amount comprises about 6.6 g per day.

31. The method claim 28, wherein the therapeutically effective amount comprises about 6.75 g per day.

32. The method of claim 29, wherein the therapeutically effective amount is a dosage regimen of three tablets of the formulation two times each day, wherein each tablet comprises about 1100 mg of balsalazide.

33. The method of claim 32, wherein the balsalazide tablet is a film-coated tablet.

34. The method of claim 28, wherein the therapeutically effective amount is a dosage regimen of three capsules of the formulation three times each day, wherein each capsule comprises about 750 mg of balsalazide.

35. The method of claim 28, wherein the mucosal healing is defined as an improvement in endoscopy/sigmoidoscopy score to 0 or1.
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