Methods of using sustained release aminopyridine compositions

Abstract

A pharmaceutical composition which comprises a therapeutically effective amount of a aminopyridine dispersed in a release matrix, including, for example, a composition that can be formulated into a stable, sustained-release oral dosage formulation, such as a tablet which provides, upon administration to a patient, a therapeutically effective plasma level of the aminopyridine for a period of at about 12 hours and the use of the composition to treat various neurological diseases, including multiple sclerosis. A method of selecting individuals based on responsiveness to a treatment, including, for example, identifying individuals who responded to treatment with a sustained release fampridine composition.

1 .- 20 . (canceled) 
     
     
         21 . A method of improving quality of life in a human multiple sclerosis patient in need thereof comprising orally administering to said patient a sustained release composition of less than 15 milligrams of 4-aminopyridine twice daily for a time period of at least two weeks. 
     
     
         22 . The method of  claim 21 , wherein the less than 15 milligrams is 10 milligrams. 
     
     
         23 . The method of  claim 21 , wherein the improvement in quality of life is shown by an improvement in walking of the patient. 
     
     
         24 . The method of  claim 22 , wherein the improvement in quality of life is shown by an improvement in walking of the patient. 
     
     
         25 . The method of  claim 21 , wherein the improvement in quality of life is shown by an improvement of the Subject's Global Impressions score of the patient. 
     
     
         26 . The method of  claim 22 , wherein the improvement in quality of life is shown by an improvement of the Subject's Global Impressions score of the patient. 
     
     
         27 . The method of  claim 21 , wherein the improvement in quality of life is shown by an improvement of the Clinician's Global Impressions score of the patient. 
     
     
         28 . The method of  claim 22 , wherein the improvement in quality of life is shown by an improvement of the Clinician's Global Impressions score of the patient. 
     
     
         29 . The method of  claim 21 , wherein said method comprises initiating treatment of said patient with 4-aminopyridine by orally administering said sustained release composition twice daily to said patient. 
     
     
         30 . The method of  claim 22 , wherein said method comprises initiating treatment of said patient with 4-aminopyridine by orally administering said sustained release composition twice daily to said patient. 
     
     
         31 . The method of  claim 21 , wherein twice daily is about every 12 hours. 
     
     
         32 . The method of  claim 22 , wherein twice daily is about every 12 hours. 
     
     
         33 . The method of  claim 21 , wherein said sustained release composition is a tablet. 
     
     
         34 . The method of  claim 22 , wherein said sustained release composition is a tablet. 
     
     
         35 . The method of  claim 31 , wherein said sustained release composition is a tablet. 
     
     
         36 . The method of  claim 32 , wherein said sustained release composition is a tablet. 
     
     
         37 . The method of  claim 21 , wherein said sustained release composition provides a release profile to obtain a C avSS  of about 15 ng/ml to about 35 ng/ml. 
     
     
         38 . The method of  claim 22 , wherein said sustained release composition provides a release profile to obtain a C avSS  of about 15 ng/ml to about 35 ng/ml. 
     
     
         39 . The method of  claim 21 , wherein said sustained release composition provides a mean T max  in a range of about 2 to about 6 hours after administration of the sustained release composition to the patient. 
     
     
         40 . The method of  claim 22 , wherein said sustained release composition provides a mean T max  in a range of about 2 to about 6 hours after administration of the sustained release composition to the patient. 
     
     
         41 . The method of  claim 21 , wherein said sustained release composition provides a mean T max  in a range of about 2 to about 5.2 hours after administration of the sustained release composition to the patient. 
     
     
         42 . The method of  claim 22 , wherein said sustained release composition provides a mean T max  in a range of about 2 to about 5.2 hours after administration of the sustained release composition to the patient. 
     
     
         43 . The method of  claim 21 , wherein said sustained release composition is capable of providing, upon administration to the patient, a release profile of the 4-aminopyridine extending over at least 6 hours. 
     
     
         44 . The method of  claim 22 , wherein said sustained release composition is capable of providing, upon administration to the patient, a release profile of the 4-aminopyridine extending over at least 6 hours. 
     
     
         45 . The method of  claim 21 , wherein said 4-aminopyridine is dispersed in a rate of release controlling polymer. 
     
     
         46 . The method of  claim 22 , wherein said 4-aminopyridine is dispersed in a rate of release controlling polymer. 
     
     
         47 . The method of  claim 21 , wherein said sustained release composition comprises a matrix, in which said 4-aminopyridine is uniformly dispersed, that is suitable for controlling the release rate of the 4-aminopyridine. 
     
     
         48 . The method of  claim 22 , wherein said sustained release composition comprises a matrix, in which said 4-aminopyridine is uniformly dispersed, that is suitable for controlling the release rate of the 4-aminopyridine. 
     
     
         49 . The method of  claim 21 , wherein said patient has relapsing remitting multiple sclerosis. 
     
     
         50 . The method of  claim 22 , wherein said patient has relapsing remitting multiple sclerosis. 
     
     
         51 . The method of  claim 21 , wherein said time period is more than two weeks. 
     
     
         52 . The method of  claim 22 , wherein said time period is more than two weeks. 
     
     
         53 . The method of  claim 21 , wherein said time period comprises twelve weeks. 
     
     
         54 . The method of  claim 22 , wherein said time period comprises twelve weeks.