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Last Updated: October 29, 2020

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Claims for Patent: 9,603,809

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Summary for Patent: 9,603,809
Title:Methods of treatment of attention deficit hyperactivity disorder
Abstract: Therapeutic compositions and methods for treatment of attention deficit disorder (ADD) or attention deficit hyperactivity disorder (ADHD) include dosage forms that deliver a therapeutic amount of active drug in a delayed and controlled release formulation. The dosage form can be administered at night and drug release is delayed for from 5 to 7 hours or longer, followed by an ascending release rate. When administered at night the composition provides early morning improvement in symptoms of ADHD and sustained improvement over a period of at least 12 hours.
Inventor(s): Lickrish; David (Grand Cayman, KY), Zhang; Feng (Pflugerville, TX)
Assignee: Ironshore Pharmaceuticals & Development, Inc. (Camana Bay, KY)
Application Number:14/716,777
Patent Claims: 1. A method of treating a condition in a subject with a disorder or condition responsive to the administration of a methylphenidate, comprising orally administering an effective amount of methylphenidate or a pharmaceutical salt thereof in a formulation comprising a core comprising methylphenidate or a pharmaceutical salt thereof and at least one pharmaceutically acceptable excipient; a sustained release layer enclosing the core and a delayed release layer enclosing the sustained release layer, wherein when the formulation is administered to a human subject in a fasted state, there is (i) a lag of at least 7 hours during which the plasma concentration of methylphenidate is less than 5% of the maximum plasma (Cmax), (ii) a plasma area under the curve at 10 hours (AUC.sub.0-10) after administration that is less than about 7% of AUC.sub.0-48; and (iii) a time to C.sub.max (T.sub.max) between 12 and 19 hours after administration, and wherein administration to a population of subjects with ADHD provides a significant improvement in ADHD related behavior or cognitive ability over a period of at least 12 continuous hours as measured by a validated rating scale.

2. The method of claim 1, wherein the improvement is measured by the ADHD-RS-IV scale, BSFQ, CGI, CGI-P, PREMB, Permanent Product Measure of Performance (PERMP) scores, or SKAMP rating scale.

3. The method of claim 1, wherein when the formulation is administered to a population of adolescent or child subjects, the formulation provides a significant improvement in Permanent Product Measure of Performance scores over a period of at least about 12 continuous hours.

4. The method of claim 3, wherein the formulation provides a significant improvement over placebo in Permanent Product Measure of Performance scores over a period from about 11 through about 23 hours post-dose.

5. The method of claim 4, wherein when the formulation is administered at about 8-10 PM, the formulation provides a significant improvement in PERMP scores during a 10-12 hour period from about 7 AM to about 9 PM the following day.

6. The method of claim 5, wherein the significant improvement is at least a 50% improvement over placebo.

7. The method of claim 1, wherein when the formulation is administered to a population of adolescent or child subjects, the formulation provides a significant improvement in SKAMP scores during a period of about 12 continuous hours.

8. The method of claim 7, wherein the formulation provides a significant improvement in SKAMP scores during a period from about 11 through about 23 hours post-dose.

9. The method of claim 8, wherein when the formulation is administered at about 8-10 PM, the formulation provides a significant improvement in SKAMP scores during a 10-12 hour period from about 7 AM to about 9 PM the following day.

10. The method of claim 1, wherein the delayed release layer comprises methacrylic acid copolymer type-B, dibutyl sebacate, mono- and di-glycerides and polysorbate 80.

11. The method of claim 1, wherein the sustained release layer comprises a drug-containing core enclosed in a coating comprising ethyl cellulose and hydroxypropyl cellulose in a ratio of about 1:3 to 1:5, dibutyl sebacate and from 25% to 50% stearate salt.

12. The method of claim 1, wherein the formulation provides a measurable improvement in BSFQ scores over placebo when administered at about 8-10 PM.

13. The method of claim 1, wherein the disorder or condition is attention deficit disorder, attention deficit hyperactivity disorder, excessive daytime sleepiness, major depressive disorder, bipolar depression, negative symptoms in schizophrenia, chronic fatigue, fatigue associated with chemotherapy or binge eating disorder.

14. The method of claim 1, wherein the disorder or condition is attention deficit disorder or attention deficit hyperactivity disorder.

15. The method of claim 1, wherein the disorder is binge eating disorder.

16. The method of claim 1, wherein administration of the formulation is timed to allow the subject to sleep during the lag period and to have absorbed a therapeutic plasma level of drug upon awakening.

17. The method of claim 16, wherein the formulation is administered at night.

18. The method of claim 1, wherein the methylphenidate or pharmaceutical salt thereof is administered in a solid pharmaceutical composition comprising: a water soluble capsule containing a plurality of beads, the beads comprising: a core comprising methylphenidate or a pharmaceutical salt thereof and at least one pharmaceutically acceptable excipient; a sustained release layer enclosing the core; and a delayed release layer enclosing the sustained release layer.

19. A method of treating AHDH in a subject in need thereof, said method comprising orally administering an effective amount of methylphenidate or a pharmaceutical salt thereof in a formulation that provides a lag of at least 7 hours during which the plasma concentration of methylphenidate is less than 5% of the maximum plasma (Cmax), followed by a period of sustained release including a time to C.sub.max (T.sub.max) between 12 and 19 hours after administration, and wherein administration in the evening provides an improvement in early morning ADHD symptoms compared to a control as measured by the BSFQ test, when the formulation is administered to a human subject in a fasted state.

20. The method of claim 19, wherein the formulation further provides a significant improvement in ADHD related behavior or cognitive ability over a period of at least 12 continuous hours as measured by a validated rating scale.

21. The method of claim 20, wherein the improvement is measured by the ADHD-RS-IV scale, CGI, CGI-P, PREMB, Permanent Product Measure of Performance (PERMP) scores, or SKAMP rating scale.

22. The method of claim 19, wherein when the formulation is administered to a population of adolescent or child subjects, the formulation provides a significant improvement in Permanent Product Measure of Performance scores over a period of at least about 12 continuous hours.

23. The method of claim 19, wherein the formulation provides a significant improvement over placebo in Permanent Product Measure of Performance (PERMP) scores over a period from about 11 through about 23 hours post-dose.

24. The method of claim 23, wherein when the formulation is administered at about 8-10 PM, the formulation provides a significant improvement in PERMP scores during a 10-12 hour period from about 7 AM to about 9 PM the following day.

25. The method of claim 24, wherein the significant improvement is at least a 50% improvement over placebo.

26. The method of claim 20, wherein when the formulation is administered to a population of adolescent or child subjects, the formulation provides a significant improvement in SKAMP scores during a period of about 12 continuous hours.

27. The method of claim 26, wherein the formulation provides a significant improvement in SKAMP scores during a period from about 11 through about 23 hours post-dose.

28. The method of claim 26, wherein when the formulation is administered at about 8-10 PM, the formulation provides a significant improvement in SKAMP scores during a 10-12 hour period from about 7 AM to about 9 PM the following day.

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