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 walking in a human multiple sclerosis patient in need thereof comprising orally administering to said patient a sustained release composition of 10 milligrams of 4-aminopyridine twice daily, without a prior period of 4-aminopyridine titration and without a subsequent period of 4-aminopyridine titration.
22 . A method of increasing walking speed in a human multiple sclerosis patient in need thereof comprising orally administering to said patient a sustained release composition of 10 milligrams of 4-aminopyridine twice daily, without a prior period of 4-aminopyridine titration and without a subsequent period of 4-aminopyridine titration.
23 . The method according to claim 21 , wherein the administering is for at least 2 weeks.
24 . The method according to claim 22 , wherein the administering is for at least 2 weeks.
25 . The method according to claim 21 , wherein the administering is for at least 12 weeks.
26 . The method according to claim 22 , wherein the administering is for at least 12 weeks.
27 . The method according to claim 21 , wherein the sustained release composition is a tablet.
28 . The method according to claim 22 , wherein the sustained release composition is a tablet.
29 . A method of improving walking in a human multiple sclerosis patient in need thereof comprising orally administering to said patient a sustained release composition of 10 milligrams of 4-aminopyridine twice daily, without a prior period of 4-aminopyridine titration and without a subsequent period of 4-aminopyridine titration, wherein the 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 human multiple sclerosis patients and wherein said administering provides efficacy in improving walking that does not differ from administering of a sustained release composition of 15 or 20 milligrams of 4-aminopyridine twice daily to human multiple sclerosis patients.
30 . A method of increasing walking speed in a human multiple sclerosis patient in need thereof comprising orally administering to said patient a sustained release composition of 10 milligrams of 4-aminopyridine twice daily, without a prior period of 4-aminopyridine titration and without a subsequent period of 4-aminopyridine titration, wherein the 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 human multiple sclerosis patients and wherein said administering provides efficacy in improving walking that does not differ from administering of a sustained release composition of 15 or 20 milligrams of 4-aminopyridine twice daily to human multiple sclerosis patients.
31 . The method according to claim 29 , wherein the sustained release composition comprises a sustained release matrix and the 4-aminopyridine, and wherein said composition provides a C avSS of 15 ng/ml to 35 ng/ml in the patient.
32 . The method according to claim 30 , wherein the sustained release composition comprises a sustained release matrix and the 4-aminopyridine, and wherein said composition provides a C avSS of 15 ng/ml to 35 ng/ml in the patient.
33 . The method according to claim 29 , wherein the administering is for at least 2 weeks.
34 . The method according to claim 30 , wherein the administering is for at least 2 weeks.
35 . The method according to claim 29 , wherein the administering is for at least 12 weeks.
36 . The method according to claim 30 , wherein the administering is for at least 12 weeks.
37 . The method according to claim 29 , wherein the sustained release composition is a tablet.
38 . The method according to claim 30 , wherein the sustained release composition is a tablet.