Formulations of lixivaptan for the treatment of polycystic disease

Abstract

Formulations of lixivaptan, and methods of using the same, are provided for the treatment of polycystic disease.

It is claimed: 
     
         1 . A method of treating a polycystic disease in a human subject, said method comprising administering to the subject a therapeutically effective amount of a pharmaceutical composition comprising lixivaptan or a pharmaceutically acceptable salt, prodrug, solvate, cocrystal, conformer, polymorph, crystalline form, tautomer, or hydrate thereof, and a pharmaceutically acceptable carrier in a divided dose regimen, wherein the total daily dose is between about 200 mg and about 500 mg. 
     
     
         2 . The method of  claim 1 , wherein the divided dose regimen consists of a first dose and a second dose. 
     
     
         3 . The method of  claim 2 , wherein the first dose is between 125 mg and 325 mg lixivaptan. 
     
     
         4 . The method of  claim 2 , wherein the second dose is between 75 mg and 175 mg lixivaptan. 
     
     
         5 . The method of  claim 2 , wherein the first dose is 200 mg lixivaptan. 
     
     
         6 . The method of  claim 2 , wherein the second dose is 100 mg lixivaptan. 
     
     
         7 . The method of any one of  claims 2 - 6 , wherein the second dose is administered about eight hours after the first dose. 
     
     
         8 . The method of any one of  claims 2 - 6 , wherein the second dose is administered about ten hours after the first dose. 
     
     
         9 . The method of any one of  claims 2 - 6 , wherein the second dose is administered about twelve hours after the first dose. 
     
     
         10 . The method of any one of  claims 2 - 9 , wherein the first dose is administered in the morning. 
     
     
         11 . The method of any one of  claims 2 - 10 , wherein the second dose is administered in the evening. 
     
     
         12 . The method of any one of  claims 1 - 11 , wherein the composition is administered for at least one week. 
     
     
         13 . The method of any one of  claims 1 - 11 , wherein the composition is administered for at least two weeks. 
     
     
         14 . The method of any one of  claims 1 - 11 , wherein the composition is administered for at least one month. 
     
     
         15 . The method of any one of  claims 1 - 14 , wherein the polycystic disease is polycystic kidney disease or polycystic liver disease. 
     
     
         16 . The method of  claim 15 , wherein the polycystic kidney disease is autosomal dominant polycystic kidney disease (ADPKD). 
     
     
         17 . A pharmaceutical composition for treating a polycystic disease in a human subject in need thereof, the pharmaceutical composition comprising a therapeutically effective amount of lixivaptan, or a pharmaceutically acceptable salt, prodrug, solvate, cocrystal, conformer, polymorph, crystalline form, tautomer, or hydrate thereof, and a pharmaceutically acceptable carrier, wherein the therapeutically effective amount is about 200 mg to about 500 mg lixivaptan delivered in a divided dose regimen. 
     
     
         18 . The pharmaceutical composition of  claim 17 , wherein the polycystic disease is polycystic kidney disease or polycystic liver disease. 
     
     
         19 . The pharmaceutical composition of  claim 18 , wherein the polycystic kidney disease is autosomal dominant polycystic kidney disease (ADPKD). 
     
     
         20 . Use of a pharmaceutical composition for treating a polycystic disease in a human subject in need thereof, wherein the pharmaceutical composition comprises a therapeutically effective amount of lixivaptan, or a pharmaceutically acceptable salt, prodrug, solvate, cocrystal, conformer, polymorph, crystalline form, tautomer, or hydrate thereof, and a pharmaceutically acceptable carrier, wherein the therapeutically effective amount is about 200 mg to about 500 mg lixivaptan delivered in a divided dose regimen. 
     
     
         21 . The use of  claim 20 , wherein the polycystic kidney disease is autosomal dominant polycystic kidney disease (ADPKD).