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.

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 with food. 
     
     
         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 - 35 . (canceled) 
     
     
         36 . The method of  claim 1 , wherein the administration of the therapeutically effective amount of balsalazide decreases a MMDAI score by 3 or more points. 
     
     
         37 . The method of  claim 36 , wherein the administration of the therapeutically effective amount of balsalazide decreases the rectal bleeding component of the MMDAI score by 1 or more points. 
     
     
         38 . The method of  claim 9 , wherein the ulcerative colitis is induced into clinical remission. 
     
     
         39 . The method of  claim 38 , wherein the clinical 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. 
     
     
         40 . The method of  claim 1 , wherein the administration of the therapeutically effective amount of balsalazide induces mucosal healing in the male subject. 
     
     
         41 . The method of  claim 40 , wherein the mucosal healing is defined as an improvement in endoscopy/sigmoidoscopy score to 0 or 1. 
     
     
         42 . The method of  claim 1 , further comprising the step of informing the male subject that the balsalazide is indicated for the treatment of mildly to moderately active ulcerative colitis in a male patient 18 years of age or older. 
     
     
         43 . The method of  claim 1 , further comprising the step of informing the male subject that the usual dose of balsalazide for treating active ulcerative colitis in adult male patients is three tablets comprising 1.1 grams per tablet taken twice per day for a total of 6.6 grams of balsalazide per day with food. 
     
     
         44 . The method of  claim 1 , wherein the male subject does not have a hypersensitivity to salicylates, balsalazide, or a balsalazide metabolite. 
     
     
         45 . The method of  claim 1 , further comprising informing the male subject the possibility of adverse reaction that include anemia, diarrhea, pharnygolaryngeal pain, urinary tract infection, arthralgia, insomnia, and pain.