METHODS FOR TREATING IRRITABLE BOWEL SYNDROME (IBS)
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 one or more symptoms of Irritable Bowel Syndrome (IBS) in a subject in need thereof, the method comprising:
orally administering to the subject a dosage form comprising 550 mg of rifaximin three times a day (TID) for 14 days,
wherein the symptoms are selected from cramping, diarrhea, constipation, lumpy stool, watery stool, frequent stool production, abdominal pain, abdominal discomfort, and/or bowel movement urgency, and wherein removing the subject from treatment after the 14 days results in from 1 to 24 weeks of adequate relief of the symptoms.
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 . (canceled)
5 . (canceled)
6 . The method of claim 1 , 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 1 , wherein adequate relief of IBS symptoms comprise a ‘yes’ response from the 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 the subject if asked whether they have had adequate relief of one or more symptoms of IBS.
10 - 19 . (canceled)
20 . The method of claim 1 , wherein the subject in need thereof is 65 years old or older.
21 . (canceled)
22 . The method of claim 1 , wherein the subject in need thereof is non-white.
23 - 25 . (canceled)
26 . The method of claim 1 , wherein treating is determined by an improvement in any one of: Weekly IBS Global Symptoms, IBS Daily Assessment of Symptoms, Daily IBS Global Symptoms, or Daily IBS Symptom of Abdominal Pain.
27 - 35 . (canceled)
36 . The method of claim 1 , wherein the subject in need thereof has a a diabetes history of longer than 20 years.
37 . The method of claim 1 , wherein removing the subject from treatment after the 14 days results in 4 weeks of adequate relief of the one or more IBS symptoms.