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 - 22 . (canceled) 
     
     
         23 . A method for treating or preventing Parkinson's disease without accompanying or by minimizing PD-LID in a subject, comprising parenterally administering to the subject an effective amount of tandospirone or a pharmaceutically acceptable salt or prodrug thereof in combination with the oral administration of an effective amount of (1) levodopa or (2) levodopa and a metabolizing enzyme inhibitor of levodopa to the subject. 
     
     
         24 . (canceled) 
     
     
         25 . A method for 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 or prodrug thereof. 
     
     
         26 . The method of  claim 23 , wherein the tandospirone or a pharmaceutically acceptable salt or prodrug thereof is a free form of tandospirone. 
     
     
         27 . The method of  claim 23 , wherein the parenteral administration has sustainability or the tandospirone or a pharmaceutically acceptable salt or prodrug thereof is sustainably administered. 
     
     
         28 . The method of  claim 23 , wherein the parenteral administration comprises transdermal administration. 
     
     
         29 . The method of  claim 23 , wherein the treatment or prevention comprises the treatment or prevention of levodopa induced dyskinesia (PD-LID), and the levodopa induced dyskinesia (PD-LID) is improved without resulting in a rebound symptom. 
     
     
         30 . The method of  claim 23 , wherein the treatment or prevention comprises the treatment or prevention of levodopa induced dyskinesia (PD-LID), and the levodopa induced dyskinesia (PD-LID) comprises peak-dose dyskinesia, diphasic dyskinesia, and a combination thereof. 
     
     
         31 . The method of  claim 23 , wherein the treatment or prevention, comprises improvement, suppression of progression, or prevention of a levodopa induced dyskinesia (PD-LID) symptom, reduction of a period of levodopa induced dyskinesia (PD-LID) manifestation, or a combination thereof. 
     
     
         32 . The method of  claim 23  wherein the treatment or prevention effects an improvement of a levodopa induced dyskinesia (PD-LID) symptom and the improvement of a levodopa induced dyskinesia (PD-LID) symptom is a clinically significant improvement or greater. 
     
     
         33 . The method of  claim 23 , wherein the treatment or prevention effects an improvement of a levodopa induced dyskinesia (PD-LID) symptom and the improvement a levodopa induced dyskinesia (PD-LID) symptom is to a sufficient level to attain a clinical effect. 
     
     
         34 . The method of  claim 23 , wherein the tandospirone or a pharmaceutically acceptable salt or prodrug thereof is an adhesive formulation. 
     
     
         35 . The method of  claim 34 , wherein the adhesive formulation is a tape/patch. 
     
     
         36 . The method of  claim 23 , wherein a drug dosage of the tandospirone or a pharmaceutically acceptable salt or prodrug thereof is 0.1 to 100 mg per day as a free form of tandospirone. 
     
     
         37 . The method of  claim 23 , wherein an amount of drug penetration for the tandospirone or a pharmaceutically acceptable salt or prodrug thereof is 0.1 to 20 mg per day as a free form of tandospirone. 
     
     
         38 . The method of  claim 23 , wherein the tandospirone or a pharmaceutically acceptable salt or prodrug thereof is a transdermally administered formulation, and a total applied area per dose is 1 to 100 cm 2 . 
     
     
         39 . The method of  claim 23 , wherein the tandospirone or a pharmaceutically acceptable salt or prodrug thereof is administered so that a human blood (plasma) tandospirone concentration is 0.05 to 20 ng/mL for 12 hours or longer per day. 
     
     
         40 . The method of  claim 23 , wherein the tandospirone or a pharmaceutically acceptable salt or prodrug thereof is administered so that a human blood (plasma) tandospirone concentration is 0.05 to 20 ng/mL for 8 to 16 hours after administration of the tandospirone or a pharmaceutically acceptable salt or prodrug thereof. 
     
     
         41 . The method of  claim 23 , wherein the tandospirone or a pharmaceutically acceptable salt or prodrug thereof is an adjunct of levodopa. 
     
     
         42 . The method of  claim 23 , wherein the tandospirone or a pharmaceutically acceptable salt or prodrug thereof is administered in combination with levodopa as the fixed-dose combination or concomitantly as separate formulations.