Highly purified eicosapentaenoic acid, as free fatty acid, reduces fecal calprotectin levels and prevents clinical relapse in ulcerative colitis patients

Abstract

The present invention relates to a method of administering an effective dose of highly purified eicosapentaenoic acid as free-fatty acid (EPA-FFA) to reduce fecal calprotectin levels and reduce the risk of clinical relapse in UC patients. The eicosapentaenoic acid, in the free fatty acid (EPA-FFA) form, has a purity of at least 95%, and more preferably at least 99%.

What is claimed is: 
     
         1 . A method to reduce the amount of fecal calprotectin (FC) by about 100 μg/g or more over a period of three to six months period relative to the amount of FC determined in a patient having a level of FC greater than about 150 μg/g to about 200 μg/g before administering highly purified EPA-FFA. 
     
     
         2 . The method of  claim 1  wherein the EPA-FFA has a purity of at least 95%. 
     
     
         3 . The method of  claim 1 , wherein the EPA-FFA is administered in a therapeutic amount from about 250 mg per day to 4 grams per day. 
     
     
         4 . The method of  claim 1 , wherein the EPA-FFA is administered in a therapeutic amount from about 1000 mg per day to 2 grams per day. 
     
     
         5 . The method of  claim 1 , wherein the purified EPA-FFA is administered with or without a pharmaceutically acceptable carrier. 
     
     
         6 . The method of  claim 1 , wherein another therapeutic agent that may be combined with the EPA-FFA is selected from a group consisting of an aminosalicylate (5-ASA), a corticosteroid, an immunomodulator, an antibiotics, and biologic therapies. 
     
     
         7 . The method of  claim 6 , wherein the aminosalicylate is selected from sulfasalazine, mesalamine, olsalazine, and balsalazide. 
     
     
         8 . The method of  claim 2 , wherein the EPA-FFA is formulated into pH-dependent, enteric-coated capsules for release of the contents in the small intestine at about pH 5.5. 
     
     
         9 . A method of preventing clinical relapse of ulcerative colitis (UC) in a subject, the method comprising:
 identifying patients at high risk of developing symptomatic relapse of UC, wherein said patients have a fecal calprotectin (FC) level ≥150 μg/g; and   administering to the subject a composition comprising eicosapentaenoic acid as free fatty acids (EPA-FFA), in a therapeutic amount effective to reduce levels of fecal calprotectin below 150 μg/g.   
     
     
         10 . The method of  claim 9  wherein the EPA-FFA has a purity of at least 95%. 
     
     
         11 . The method of  claim 9 , wherein the therapeutic amount of EPA-FFA is from about 250 mg per day to 4 grams per day. 
     
     
         12 . The method of  claim 9 , wherein the therapeutic amount of EPA-FFA is from about 1000 mg per day to 2 grams per day. 
     
     
         13 . The method of  claim 9 , wherein the composition further comprises a pharmaceutically acceptable carrier. 
     
     
         14 . The method of  claim 9 , wherein the composition further comprises another therapeutic agent selected from a group consisting of an aminosalicylate (5-ASA), a corticosteroid, an immunomodulator, an antibiotics, and biologic therapies. 
     
     
         15 . The method of  claim 14 , wherein the aminosalicylate is selected from sulfasalazine, mesalamine, olsalazine, and balsalazide. 
     
     
         16 . The method of  claim 10 , wherein the EPA-FFA is formulated into pH-dependent, enteric-coated capsules for release of the contents in the small intestine at about pH 5.5.