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Claims for Patent: 8,470,853

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Claims for Patent: 8,470,853

Title:Transdermal methods and systems for the delivery of anti-migraine compounds
Abstract: Iontophoretic patches for the delivery of anti-migraine compounds and methods of using the patches are described.
Inventor(s): Anderson; Carter R. (Inver Grove Heights, MN), Morris; Russell L. (Lindstrom, MN), Sebree; Terri B. (Gladwyne, PA)
Assignee: NuPathe Inc. (Conshohocken, PA)
Application Number:13/105,585
Patent Claims: 1. A method for treating a human for a migraine, comprising transdermally administering to said human an effective amount of a triptan compound in less than one hour, and maintaining an effective steady state plasma concentration of the triptan compound for at least one hour using an integrated iontophoretic patch, wherein said patch uses a first current density and a second current density selected such that said first current density and said second current density do not substantially irritate said human's skin, and wherein an effective dosage level is reached in said human in less than one hour and a maintenance level is continued for one or more hours, wherein said effective dosage level provides a plasma concentration of about 10 ng/mL or greater, such that said human is treated for said migraine.

2. The method of claim 1, wherein said triptan compound is selected from sumatriptan, naratriptan and pharmaceutically acceptable salts thereof.

3. The method of claim 1, wherein said migraine is selected from familiar hemiplegic migraines (with and without aura), chronic paroxysmal headaches, cluster headaches, migraine headaches, basilar migraines, and atypical headaches accompanied by autonomic symptoms.

4. The method of claim 1, wherein the effective amount provides a plasma concentration of about 20 ng/mL or greater.

5. The method of claim 1, wherein said first current density and said second current density are selected such that usage of said patch for delivery of an effective amount of said triptan compound does not result in a skin erythema score of greater than 2.50 immediately after patch removal.

6. The method of claim 5, wherein said first current density and said second current density are selected such that usage of said patch for delivery of an effective amount of said triptan compound does not result in a skin erythema score of greater than 2.00 immediately after patch removal.

7. The method of claim 1, wherein said patch is fully integrated.

8. The method of claim 1, wherein said human is treated without substantial side effects.

9. The method of claim 1, wherein the triptan compound is formulated in a flowable hydrogel.

10. The method of claim 1, wherein said iontophoretic patch comprises an electrode which does not react to form an insoluble salt of said triptan compound.

11. The method of claim 10, wherein said electrode comprises zinc or zinc coating.

12. The method of claim 1, wherein said effective steady state plasma concentration of said triptan compound is about 10 ng/ml.

13. The method of claim 1, wherein said steady state plasma concentration is maintained for about four hours or greater.

14. The method of claim 13, wherein said steady state plasma concentration is maintained for about six hours or greater.
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