COMPOSITION AND METHOD FOR TREATING NEUROLOGICAL DISEASE
Disclosed are compositions comprising amantadine, or a pharmaceutically acceptable salt thereof, and one or more excipients, wherein at least one of the excipients modifies release of amantadine. Methods of administering the same are also provided.
1 - 54 . (canceled)
55 . An amantadine once-daily oral composition comprising:
amantadine, or a pharmaceutically acceptable salt thereof,
wherein at least a portion of the amantadine, or pharmaceutically acceptable salt thereof, is present in a form for extending release, wherein the form for extending release comprises at least one excipient for modifying release and amantadine, or pharmaceutically acceptable salt thereof, and
wherein the form for extending release is characterized by a mean change in amantadine plasma concentration as a function of time (dC/dT) that is less than 40% of the dC/dT provided by the same quantity of amantadine, or a pharmaceutical acceptable salt thereof, in an immediate release form,
wherein, when measured in a single dose human pharmacokinetic study, the dC/dT of the form for extending release is measured over the time period between 2 hours and 4 hours after administration; and
the dC/dT for the immediate release form is measured over the time period between administration and Tmax of the immediate release form; and.
wherein the amantadine once-daily oral composition comprises from 50 mg to 400 mg of amantadine or a pharmaceutically acceptable salt thereof.
56 . The amantadine once-daily oral composition of claim 55 , wherein at least 50% of the amantadine, or a pharmaceutically acceptable salt thereof, in the amantadine once-daily oral composition is present in the form for extending release.
57 . The amantadine once-daily oral composition of claim 55 , wherein at least 75% of the amantadine, or a pharmaceutically acceptable salt thereof, in the amantadine once-daily oral composition is present in the form for extending release.
58 . The amantadine once-daily oral composition of claim 55 , wherein at least 90% of the amantadine, or a pharmaceutically acceptable salt thereof, in the amantadine once-daily oral composition is present in the form for extending release.
59 . The amantadine once-daily oral composition of claim 55 , wherein the amantadine once-daily oral composition comprises amantadine, or a pharmaceutically acceptable salt thereof, in an immediate release form.
60 . The amantadine once-daily oral composition of claim 55 , wherein the amantadine once-daily oral composition does not comprise amantadine, or a pharmaceutically acceptable salt thereof, in an immediate release form.