Methods for treating bowel diseases

Abstract

The present invention provides new methods of treating bowel disease (BD) by increasing a durability of response; treating BD in males; treating BD in adolescent subjects; treating bloating due to BD in males; and methods of maintaining remission of BD.

1 . A method of treating bowel disease (BD) with a durability of antibiotic response, comprising:
 administering a therapeutically effective amount of rifaximin to a subject in need thereof,   selecting subjects who respond to treatment after being treated for between about 1 and about 24 weeks; and   removing a responding subject from treatment wherein after removal of treatment there is a durability of response.   
     
     
         2 . (canceled) 
     
     
         3 . The method of  claim 1 , wherein the bowel disease comprises hepatic encephalopathy. 
     
     
         4 . The method of  claim 3 , wherein a subject with hepatic encephalopathy will be administered rifaximin for between about 28 days and about 24 months. 
     
     
         5 . The method of  claim 1 , wherein durability of response comprises continuous adequate relief of symptoms after removal of treatment. 
     
     
         6 . (canceled) 
     
     
         7 . The method of  claim 1 , wherein the therapeutically effective amount comprises from between about 50 mg and about 6000 mg, from between about 100 mg and about 2500 mg BID, from between about 50 mg about 2000 mg TID, 550 mg TID, 550 mg BID, 600 mg/day, 600 mg TID, 600 mg BID, or 1650 mg/day. 
     
     
         8 - 17 . (canceled) 
     
     
         18 . The method of  claim 1 , wherein subjects are treated from between about 7 days and about 12 weeks prior to selection. 
     
     
         19 . (canceled) 
     
     
         20 . (canceled) 
     
     
         21 . The method of  claim 1 , wherein the durability of response comprises from between about 7 days and about 24 weeks of adequate relief of symptoms or from between about 1 and about 5 weeks of adequate relief of symptoms. 
     
     
         22 . (canceled) 
     
     
         23 . The method of  claim 21 , wherein symptoms comprise one or more of overall BD symptoms or bloating. 
     
     
         24 . The method of  claim 21 , wherein adequate relief of BD symptoms comprises a reduction of BD symptoms or wherein adequate relief of bloating symptoms comprises a reduction of bloating symptoms. 
     
     
         25 . The method of  claim 24 , wherein the reduction in BD symptoms is a reduction from baseline symptoms or wherein the reduction in bloating symptoms is a reduction from baseline symptoms. 
     
     
         26 . The method of  claim 25 , wherein baseline symptoms are established prior to treatment. 
     
     
         27 . (canceled) 
     
     
         28 . The method of  claim 24 , wherein adequate relief of BD symptoms or adequate relief of bloating symptoms comprise an affirmative response from a subject if asked weather they have had adequate relief of symptom of BD. 
     
     
         29 . The method of  claim 1 , wherein BD symptoms comprise one or more of cramping, pain, diarrhea, constipation, lumpy stool, watery stool, frequent stool production, abdominal pain, abdominal discomfort, urgency, or tenesmus. 
     
     
         30 - 34 . (canceled) 
     
     
         35 . The method of  claim 24 , wherein bloating symptoms comprise one or more of the symptoms of abdominal fullness, bloating, gas, or swelling. 
     
     
         36 . The method of  claim 1 , wherein the BD comprises one or more of irritable bowel syndrome (IBS), Crohn's disease, traveler's diarrhea, ulcerative colitis, enteritis, small intestinal bacterial overgrowth, chronic pancreatitis, pancreatic insufficiency, colitis, diverticular disease, hepatic encephalopathy, or pouchitis. 
     
     
         37 . The method of  claim 1 , wherein selecting comprises following dosing instructions on a package insert of a pharmaceutical product. 
     
     
         38 . The method of  claim 37 , wherein the package insert instructs to administer the rifaximin for 14 days. 
     
     
         39 . (canceled) 
     
     
         40 . (canceled) 
     
     
         41 . The method of  claim 37 , wherein the product comprises 550 mg of rifaximin labeled for treatment of irritable bowel syndrome, 550 mg of rifaximin labeled for treatment of hepatic encephalopathy, 600 mg of rifaximin labeled for treatment of irritable bowel syndrome, 600 mg of rifaximin labeled for treatment of hepatic encephalopathy, or 550 mg of rifaximin labeled for treatment of Travelers' diarrhea. 
     
     
         42 - 77 . (canceled)