Therapeutic drug for dyskinesia

Abstract

The present invention provides a therapeutic drug that is useful for levodopa induced dyskinesia in Parkinson's disease. In particular, the present invention provides a composition and method for treating, improving, suppressing the progression, or preventing motor complications associated with levodopa therapy for Parkinson's disease, especially levodopa induced dyskinesia (PD-LID), comprising tandospirone or a pharmaceutically acceptable salt or prodrug thereof, wherein the tandospirone or a pharmaceutically acceptable salt or prodrug thereof is parenterally administered.

1 - 21 . (canceled) 
     
     
         22 . A method for treating or improving the exacerbation in quality of response to levodopa therapy of a Parkinson's disease patient with dyskinesia in a subject, comprising parenterally administering to the subject an effective amount of tandospirone or a pharmaceutically acceptable salt thereof. 
     
     
         23 . The method of  claim 22 , wherein the parenteral administration is selected from transdermal administration, intradermal administration, subcutaneous administration, intramuscular administration, and a combination thereof. 
     
     
         24 . The method of  claim 22 , wherein the parenteral administration comprises transdermal administration. 
     
     
         25 . The method of  claim 22 , wherein the tandospirone or a pharmaceutically acceptable salt thereof is provided as a transdermally administered formulation. 
     
     
         26 . The method of  claim 22 , wherein the tandospirone or a pharmaceutically acceptable salt thereof is provided as an adhesive formulation. 
     
     
         27 . The method of  claim 25 , wherein the transdermally administered formulation is a tape/patch. 
     
     
         28 . The method of  claim 22 , wherein a drug dosage of the tandospirone or a pharmaceutically acceptable salt thereof is 0.1 to 100 mg per day as a free form of tandospirone. 
     
     
         29 . The method of  claim 22 , wherein an amount of drug penetration for the tandospirone or a pharmaceutically acceptable salt thereof is 0.1 to 20 mg per day as a free form of tandospirone. 
     
     
         30 . The method of  claim 22 , wherein the tandospirone or a pharmaceutically acceptable salt thereof is provided as a transdermally administered formulation, and a total applied area per dose is 1 to 100 cm 2 . 
     
     
         31 . The method of  claim 22 , wherein the tandospirone or a pharmaceutically acceptable salt thereof is an adjunct of levodopa. 
     
     
         32 . The method of  claim 22 , wherein the tandospirone or a pharmaceutically acceptable salt thereof is used with levodopa as the fixed-dose combination or concomitantly as separate formulations. 
     
     
         33 . A pharmaceutical composition for use in treating or preventing Parkinson's disease without accompanying or by minimizing PD-LID in a subject, comprising an effective amount of tandospirone or a pharmaceutically acceptable salt thereof and (1) an effective amount of levodopa or (2) levodopa and a metabolizing enzyme inhibitor of levodopa, wherein the tandospirone or a pharmaceutically acceptable salt thereof is an adjunct of levodopa, and wherein the composition is suitable for parenteral administration. 
     
     
         34 . The pharmaceutical composition of  claim 33 , wherein the tandospirone or a pharmaceutically acceptable salt thereof and the (1) or (2) are suitable for simultaneous administration or separate administration at different times.