FORMULATIONS AND USES OF 2-HYDROXY-5-PHENYLAZOBENZOIC ACID DERIVATIVES FOR THE TREATMENT OF MALES
The instant application provides methods and compositions for the treatment of male subjects having ulcerative colitis.
1 . A method treating a gastrointestinal disorder comprising administering to a 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 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 1 or more points.
20 . A method of inducing clinical remission of ulcerative colitis in a male subject comprising; administering to the 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 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 or 1.