Terlipressin compositions and their methods of use

Abstract

Methods are disclosed of treating or preventing hypotension (e.g., neurogenic orthostatic hypotension or postprandial hypotension) or portal hypertension (e.g., bleeding esophageal varices associated with portal hypertension) or ascites (e.g., ascites associated with liver cirrhosis), by oral administration to affected subjects of compositions comprising a therapeutically effective amount of terlipressin or a pharmaceutically acceptable salt thereof.

1 . A method of treating a subject suffering from a condition selected from hypotension and portal hypertension, the method comprising orally administering a pharmaceutical composition configured as a tablet or capsule comprising a therapeutically effective amount of terlipressin or a pharmaceutically acceptable salt thereof, thereby treating the subject, wherein if the condition is portal hypertension the tablet or capsule comprises 5-30 mg terlipressin and is administered 1-4 times daily. 
     
     
         2 . The method of  claim 1 , wherein the tablet or capsule is administered 1, 2, 3 or 4 times daily. 
     
     
         3 - 7 . (canceled) 
     
     
         8 . The method of  claim 1 , wherein the tablet or capsule comprises 5 to 30 mg terlipressin or a pharmaceutically acceptable salt thereof. 
     
     
         9 - 12 . (canceled) 
     
     
         13 . The method of  claim 1 , wherein the subject is administered 5 to 100 mg terlipressin daily. 
     
     
         14 - 16 . (canceled) 
     
     
         17 . The method of  claim 1 , wherein the method results in reduced side effects relative to a method of administering terlipressin by other forms of administration. 
     
     
         18 . The method of  claim 1 , wherein the method provides greater patient compliance relative a method of administering terlipressin by other forms of administration. 
     
     
         19 . The method of  claim 1 , wherein the condition is hypotension. 
     
     
         20 . The method of  claim 19  wherein the hypotension is neurogenic orthostatic. 
     
     
         21 . The method of  claim 19  wherein the hypotension is post-prandial. 
     
     
         22 . The method of  claim 1 , wherein the condition is portal hypertension. 
     
     
         23 - 26 . (canceled) 
     
     
         27 . The method of  claim 22  wherein the terlipressin is administered in combination with a therapeutically effective amount of at least one liver fibrosis agent and/or at least one beta-blocker. 
     
     
         28 - 40 . (canceled) 
     
     
         41 . An oral dosage form which comprises a therapeutically effective amount of terlipressin, or a pharmaceutically acceptable salt thereof of terlipressin, or a pharmaceutically acceptable salt thereof. 
     
     
         42 . The oral dosage form of  claim 41 , wherein the form comprises about 5, 10, 15, 20, 25, 30, or 50 mg terlipressin. 
     
     
         43 . (canceled) 
     
     
         44 . The oral dosage form of  claim 41  wherein the form comprises at least 5 mg terlipressin. 
     
     
         45 . The oral dosage form of  claim 41 , wherein the oral dosage form is enteric-coated. 
     
     
         46 - 52 . (canceled) 
     
     
         53 . The oral dosage form of  claim 41 , further comprising a therapeutically effective amount of at least one liver fibrosis agent and/or at least one beta-blocker. 
     
     
         54 - 57 . (canceled) 
     
     
         58 . The oral dosage form of  claim 41 , for treatment of a subject suffering from portal hypertension and/or variceal bleeding. 
     
     
         59 - 60 . (canceled) 
     
     
         61 . The method of  claim 22 , wherein the subject is treated for bleeding esophageal varices associated with portal hypertension. 
     
     
         62 . The method of  claim 13 , wherein the subject is administered 20 to 100 mg terlipressin daily.