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Claims for Patent: 7,973,058

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Claims for Patent: 7,973,058

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:12/181,142
Patent Claims: 1. A method for treating a migraine in a human, the method comprising: administering an anti-migraine agent in the form of a triptan compound to said human using an integrated iontophoretic transdermal patch, wherein the triptan is delivered in a delivery sequence which includes: an initial first stage delivery wherein current densities average between about 0.05 and about 0.20 mA/cm.sup.2 during a significant portion of the initial first stage delivery such that a therapeutically effective dosage level in less than one hour is provided to the subject, wherein the therapeutically effective dosage level is a plasma concentration of greater than 10 ng/mL; and a second stage delivery wherein current densities average between about 0.01 and about 0.2 mA/cm.sup.2 during a significant portion of said second stage delivery such that a maintenance level is provided for one or more hours, wherein said current densities of said first stage and said second stage are selected such that said current densities do not substantially irritate said human's skin.

2. The method of claim 1, wherein said anti-migraine agent is selected from sumatriptan and salts thereof.

3. The method of claim 1, wherein the maintenance level is a plasma concentration of the anti-migraine agent of about 10 ng/mL or greater.

4. The method of claim 3, wherein the average current density is about 0.1 mA/cm.sup.2 during a significant portion of the initial first stage delivery.

5. The method of claim 4, wherein the average current density is about 0.05 mA/cm.sup.2 during a significant portion of the second stage delivery.

6. The method of claim 5, wherein the maintenance level is provided for about four hours or greater.

7. The method of claim 6, wherein the maintenance level is provided for about six hours or greater.

8. The method of claim 6, wherein the current densities are selected such that usage of the patch does not result in a skin erythema score of greater than 2.00 immediately after patch removal.

9. The method of claim 8, wherein the current densities are selected such that usage of the patch does not result in a skin erythema score of greater than 1.00 immediately after patch removal.

10. The method of claim 8, wherein the human is treated without substantial side effects.

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

12. The method of claim 11, wherein the iontophoretic patch includes an electrode comprising zinc or a zinc coating.

13. The method of claim 12, wherein the triptan is formulated in a flowable hydrogel.
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