Methods for treating pruritus

Abstract

The present invention relates to methods for treating uremic pruritus with anti-pruritic compositions.

1 . A method of treating uremic pruritus comprising administering an effective amount of an anti-pruritus agent to a human patient in need of such treatment, wherein the anti-pruritus agent is nalbuphine or a pharmaceutically acceptable salt or ester thereof and wherein the anti-pruritus agent is not administered in combination with a second anti-pruritus agent. 
     
     
         2 . The method of  claim 1 , wherein the patient is under dialysis treatment. 
     
     
         3 . The method of  claim 1 , wherein the patient has a chronic kidney disease or a reduced renal function. 
     
     
         4 . The method of  claim 1 , wherein the anti-pruritus agent is administered at an initial oral dose of from about 15 mg to about 60 mg twice a day and then titrated to an effective dose. 
     
     
         5 . The method of  claim 1 , wherein the anti-pruritus agent is administered at an initial dose of from about 15 mg to about 60 mg once a day and then titrated to an effective dose. 
     
     
         6 . The method of  claim 1 , wherein the anti-pruritus agent is administered at an initial dose of from about 15 mg to about 60 mg twice a day or once a day for about 3 days and then titrated to an effective dose at about 15 mg to about 60 mg increment. 
     
     
         7 . The method of  claim 1 , wherein the maximum dose of the anti-pruritus agent is about 180 mg when said agent is administered to a patient twice a day, or 360 mg when said agent is administered to a patient once a day. 
     
     
         8 . The method of  claim 1 , wherein the anti-pruritus agent is administered with an AM dosage and a PM dosage and wherein the PM dosage is higher than the AM dosage, or vice versa. 
     
     
         9 . The method of  claim 1 , wherein the anti-pruritus agent is in an extended release oral dosage form and the administration provides in the patient a mean C max  of from about 1.9 ng/mL to about 102 ng/mL. 
     
     
         10 . The method of  claim 1 , wherein the anti-pruritus agent is in an extended release oral dosage form and the administration provides in the patient a mean C max  of from about 30 ng/mL to about 60 ng/mL. 
     
     
         11 . The method of  claim 1 , wherein the anti-pruritus agent is in an extended release oral dosage form and the administration provides in the patient an AUC (0-∞)  of from about 37 ng·hr/mL to about 910 ng·hr/mL. 
     
     
         12 . The method of  claim 1 , wherein the anti-pruritus agent is in an extended release oral dosage form and the administration provides in the patient an AUC (0-∞)  of from about 200 ng·hr/mL to about 500 ng·hr/mL. 
     
     
         13 . The method of  claim 1 , wherein the anti-pruritus agent is in an extended release oral dosage form and the administration provides in the patient an AUC (0∞)  of from about 70 ng·hr/mL to about 210 ng·hr/mL. 
     
     
         14 . The method of  claim 1 , wherein the anti-pruritus agent is at least 50% dialyzable when administered to the patient under the treatment of dialysis. 
     
     
         15 . The method of  claim 1 , wherein one or more of the metabolites of the anti-pruritus agent do not have detectable anti-pruritus activity. 
     
     
         16 . The method of  claim 1 , wherein at least one metabolite of the anti-pruritus agent is at least 50% dialyzable when the anti-pruritus agent is administered to a patient under dialysis treatment. 
     
     
         17 . A method of treating uremic pruritus comprising administering an effective amount of an anti-pruritus agent to a human patient in need of such treatment, wherein the anti-pruritus agent is nalbuphine or a pharmaceutically acceptable salt or ester thereof and wherein the anti-pruritus agent is in an extended release oral dosage form. 
     
     
         18 - 30 . (canceled)