Formulations and methods for treating ulcerative colitis

Abstract

This invention provides composition and methods to prevent, treat or alleviate a symptom of ulcerative colitis comprising administering to a patient dolcanatide.

1 . A method for preventing, treating, or alleviating a symptom of ulcerative colitis, the method comprising rectally administering to a subject in need thereof a therapeutically effective amount of a composition comprising plecanatide (SEQ ID NO: 1). 
     
     
         2 . The method of  claim 1 , wherein the therapeutically effective amount is between about 1 mg to about 10 mg per dose. 
     
     
         3 . The method of  claim 2 , wherein the dose therapeutically effective amount is 3 mg, 6 mg, or 9 mg. 
     
     
         4 . The method of  claim 1 , wherein the composition is administered once daily. 
     
     
         5 . The method of  claim 4 , wherein the composition is administered prior to bedtime. 
     
     
         6 . The method of  claim 1 , where the composition is administered once daily for 28 days. 
     
     
         7 . The method of  claim 1 , wherein the composition is an enema. 
     
     
         8 . The method of  claim 1 , wherein the composition is a suppository. 
     
     
         9 . The method of  claim 1 , wherein the release of the composition is time dependent. 
     
     
         10 .- 15 . (canceled) 
     
     
         16 . The method of  claim 1 , wherein the composition is a liquid composition. 
     
     
         17 . The method of  claim 16 , wherein the liquid composition comprises saline. 
     
     
         18 . The method of  claim 3 , wherein the therapeutically effective amount is 6 mg. 
     
     
         19 . The method of  claim 4 , wherein the composition is administered once daily for at least 28 days. 
     
     
         20 . The method of  claim 1 , wherein the ulcerative colitis is mild-to-moderate ulcerative colitis.