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Claims for Patent: 8,155,737

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Claims for Patent: 8,155,737

Title:Pharmacokinetics of iontophoretic sumatriptan administration
Abstract: Improved pharmacokinetic profiles for the iontophoretic delivery of sumatriptan are described.
Inventor(s): Sebree; Terri B. (Gladwyne, PA), Pierce; Mark (Essex, CT), O'Neill; Carol (Conshohocken, PA)
Assignee: NuPathe, Inc. (Conshohocken, PA)
Application Number:12/142,604
Patent Claims: 1. A method for treating a sumatriptan responsive state in a human, comprising iontophoretically administering to said human an effective amount of sumatriptan using a current of about 4 mA for a high current treatment period of about one hour and a current of about 2 mA for a subsequent low current treatment period, such that said human is treated for said sumatriptan responsive state, wherein the sumatriptan is administered such that an AUC.sub.0-inf of between about 67 and about 158 hr*ng/mL within a 95% confidence interval is achieved in the human's plasma; and wherein the sumatriptan is administered such that a C.sub.max of between about 14 and about 38 ng/mL within a 95% confidence interval is achieved in the human's plasma.

2. The method of claim 1, wherein said amount of sumatriptan is about 10 mg.

3. The method according to claim 1, wherein the sumatriptan is administered such that an AUC.sub.0-inf between about 99 and 128 hr*ng/mL within a 95% confidence interval is achieved in the human's plasma and a C.sub.max between about 20 and about 28 ng/mL within a 95% confidence interval is achieved in the human's plasma.

4. The method of claim 3, wherein about 10 mg of sumatriptan is administered to said human.

5. The method according to claim 1, wherein the sumatriptan is administered such that an AUC.sub.0-inf between about 99 and about 128 hr*ng/mL within a 95% confidence interval is achieved in the human's plasma; or wherein the sumatriptan is administered such that a C.sub.max between about 20 and about 28 ng/mL within a 95% confidence interval is achieved in the human's plasma; or wherein the sumatriptan is administered such that a C.sub.max of about 23-25 ng/mL is achieved and plasma concentrations are sustained for at least three hours; or wherein the sumatriptan is administered such that an AUC.sub.0-inf between about 99 and 128 hr*ng/mL and a C.sub.max between about 20 to about 28 ng/mL are achieved in the human's plasma.

6. The method according to claim 1, wherein said effective amount of sumatriptan is administered without substantial adverse effects.

7. The method of claim 6, wherein said adverse effects comprise pain, pressure sensations or atypical sensations.

8. The method according to claim 1, wherein said administration of sumatriptan results in an AUC.sub.0-inf, t.sub.1/2, or C.sub.max coefficient of variance (CV) of less than about 25%.

9. The method according to claim 1, wherein said administration of sumatriptan results in an AUC.sub.0-inf coefficient of variance less than twice the AUC.sub.0-inf coefficient of variance for subcutaneous administration of sumatriptan.

10. The method of claim 1, wherein said effective amount of sumatriptan is administered without substantially irritating said human's skin.

11. The method of claim 10, wherein said iontophoretic administration of sumatriptan causes little or no erythema.

12. The method of claim 10, wherein said iontophoretic administration of sumatriptan causes little or no punctuate lesions.

13. The method of claim 1, wherein said sumatriptan responsive state is a migraine.

14. A method for treating a sumatriptan responsive state in a human, comprising iontophoretically administering to said human an amount of sumatriptan using a current of 4.0 mA or greater for at least a portion of the treatment period, such that said sumatriptan responsive state in said human is treated, wherein the sumatriptan is administered such that an AUC.sub.0-inf of between about 67 and about 158 hr*ng/mL within a 95% confidence interval is achieved in the human's plasma; and wherein the sumatriptan is administered such that a C.sub.max of between about 14 and about 38 ng/mL within a 95% confidence interval is achieved in the human's plasma.

15. The method of claim 14, wherein said portion of said treatment period is about thirty minutes to about 90 minutes.

16. The method of claim 14, wherein said method further comprises a low current treatment period using a current of between about 1.5 to about 2.5 mA.

17. The method of claim 16, wherein said low current treatment period uses a current of about 2.0 mA.

18. The method of claim 16, wherein said low current treatment period is between about 2 hours and about 4 hours in length.

19. The method of claim 14, wherein an effective amount of sumatriptan is administered without substantially irritating said human's skin.

20. The method of claim 19, wherein said iontophoretic administration of sumatriptan causes little or no erythema.

21. The method of claim 19, wherein said iontophoretic administration of sumatriptan causes little or no punctuate lesions.

22. The method of claim 14, wherein said sumatriptan responsive state is a migraine.
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