Inhalation formulations of treprostinil

Abstract

The present invention describes novel methods for using Treprostinil or its derivative, or a pharmaceutically acceptable salt thereof, for the treatment and/or prevention of ischemic lesions, such as digital ulcers, in subjects with scleroderma (including systemic sclerosis), Buerger's disease, Raynaud's disease, Raynaud's phenomenon and/or other conditions that cause such lesions. The invention also relates to kits for treatment and/or prevention of ischemic lesions, comprising an effective amount of Treprostinil or its derivative, or a pharmaceutically acceptable salt thereof.

1 .- 7 . (canceled) 
     
     
         8 . A method of treating a fibrosis of a blood vessel comprising administering to a subject in need thereof an effective amount of treprostinil or a pharmaceutically acceptable salt or ester thereof. 
     
     
         9 . The method of  claim 8 , wherein a pharmaceutically acceptable salt of treprostinil is administered. 
     
     
         10 . The method of  claim 8 , wherein the subject is a human being. 
     
     
         11 . The method of  claim 8 , wherein said administering is performed subcutaneously. 
     
     
         12 . The method of  claim 8 , wherein said administering is performed by continuous subcutaneous infusion. 
     
     
         13 . The method of  claim 8 , wherein said administering is performed intravenously. 
     
     
         14 . The method of  claim 8 , wherein said administering is performed orally. 
     
     
         15 . The method of  claim 14 , wherein the treprostinil or a pharmaceutically acceptable salt or ester thereof, is administered in an orally available form selected from the group consisting of tablets and capsules. 
     
     
         16 . The method of  claim 8 , wherein said administering is performed by inhalation. 
     
     
         17 . The method of  claim 8 , wherein the effective amount is at least 1.0 ng/kg of body weight/min. 
     
     
         18 . The method of  claim 8 , wherein said administering is performed by continuous subcutaneous infusion by an infusion pump. 
     
     
         19 . The method of  claim 10 , wherein said human subject has Buerger's disease.