Methods for treating irritable bowel syndrome (ibs)

Abstract

The present invention provides new methods and kits for treating IBS; treating IBS in females; treating IBS in older subjects; and treating IBS in non-white subjects.

1 . A method of treating Irritable Bowel Syndrome (IBS), comprising:
 administering 550 mg of rifaximin TID to a subject in need thereof,   thereby treating Irritable Bowel Syndrome (IBS).   
     
     
         2 . The method of  claim 1 , wherein the IBS is diarrhea-predominant IBS. 
     
     
         3 . The method of  claim 1 , wherein the IBS is alternating -predominant IBS. 
     
     
         4 . The method of  claim 1 , wherein a subject is administered rifaximin for between about 14 days and about 24 months. 
     
     
         5 . The method of  claim 1 , wherein treating IBS comprises treating one or more of IBS symptoms or the IBS symptom of bloating. 
     
     
         6 . The method of  claim 5 , wherein the treating one or more IBS symptoms is a reduction from baseline symptoms. 
     
     
         7 . The method of  claim 6 , wherein baseline symptoms are established prior to treatment. 
     
     
         8 . The method of  claim 6 , wherein adequate relief of IBS symptoms comprise a ‘yes’ response from a subject when asked the question comprising “In the past 7 days, have you had adequate relief of your symptom of your IBS symptoms?” 
     
     
         9 . The method of  claim 8 , wherein adequate relief of IBS symptoms comprises an affirmative response from a subject if asked weather they have had adequate relief of symptom of IBS. 
     
     
         10 . The method of  claim 1 , wherein IBS symptoms comprise one or more of cramping, pain, diarrhea, constipation, lumpy stool, watery stool, frequent stool production, abdominal pain, abdominal discomfort, urgency, or tenesmus. 
     
     
         11 . The method of  claim 5 , wherein adequate relief of bloating symptoms comprises a reduction of bloating symptoms. 
     
     
         12 . The method of  claim 11 , wherein the reduction in bloating symptoms is a reduction from baseline symptoms. 
     
     
         13 . The method of  claim 12 , wherein baseline symptoms are established prior to treatment. 
     
     
         14 . The method of  claim 13 , wherein adequate relief of bloating symptoms comprise a ‘yes’ response from a subject when asked a question, comprising “In the past 7 days, have you had adequate relief of your IBS symptom of bloating?” 
     
     
         15 . The method of  claim 14 , wherein adequate relief of IBS symptoms comprises an affirmative response from a subject if asked weather they have had adequate relief of the IBS symptom of bloating. 
     
     
         16 . The method of  claim 1 , wherein the subject is female. 
     
     
         17 . The method of  claim 16 , further comprising determining the gender of a subject and administering the therapeutically effective amount to a female subject. 
     
     
         18 . (canceled) 
     
     
         19 . (canceled) 
     
     
         20 . The method of  claim 1 , wherein the subject is 65 years old or older. 
     
     
         21 . (canceled) 
     
     
         22 . The method of  claim 1 , wherein the subject is non-white. 
     
     
         23 . A kit for treating IBS comprising a container comprising a rifaximin and a label which describes that administration of a therapeutically effective amount of rifaximin results treatment of IBS. 
     
     
         24 . The kit of  claim 23 , wherein the label further comprises instructions regarding the prescribing of rifaximin based on age, sex or race. 
     
     
         25 . (canceled) 
     
     
         26 . The method of  claim 1  wherein treating is determined by an improvement in any one of: Weekly IBS Global Symptoms, Weekly IBS Symptom of Bloating, IBS Daily Assessment of Symptoms, Daily IBS Global Symptoms, Daily IBS Symptom of Bloating, or Daily IBS Symptom of Abdominal Pain. 
     
     
         27 . A method of treating abdominal pain associated with Irritable Bowel Syndrome (IBS), comprising:
 administering 550 mg of rifaximin TID to a subject in need thereof,   thereby treating abdominal pain Irritable Bowel Syndrome (IBS).   
     
     
         28 . The method of  claim 27 , wherein the IBS is diarrhea-predominant IBS. 
     
     
         29 . The method of  claim 27 , wherein the IBS is alternating -predominant IBS. 
     
     
         30 . The method of  claim 1 , wherein treating IBS comprises treating an IBS symptom of pain. 
     
     
         31 . The method of  claim 1 , wherein the IBS symptom of pain comprise abdominal pain. 
     
     
         32 . The method of  claim 31 , wherein treating the IBS symptom of pain comprise adequate relief of pain. 
     
     
         33 . The method of  claim 32 , wherein adequate relief of pain comprises a reduction of pain symptoms. 
     
     
         34 . The method of  claim 33 , wherein the reduction in pain comprises a reduction from baseline symptoms. 
     
     
         35 . The method of  claim 34 , wherein baseline symptoms are established prior to treatment. 
     
     
         36 . The method of  claim 1 , wherein a subject having a diabetes history of longer than 20 years is predicted to respond to treatment with rifaximin.