METHODS OF USING SUSTAINED RELEASE AMINOPYRIDINE COMPOSITIONS
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.