PHARMACEUTICAL COMPOSITIONS AND METHODS FOR TREATING AGE-RELATED MACULAR DEGENERATION WITH MELATONIN ANALOGUES

• US 20110229464A1
• Filed: 06/17/2009
• Published: 09/22/2011
• Est. Priority Date: 06/19/2008
• Status: Active Grant

• Current Assignee: Takeda Pharmaceutical Company Limited
• Original Assignee: Takeda Pharmaceutical Company Limited
• Inventors: Hirai, Keisuke, Shintani, Yasushi, Baron, David, Uchikawa, Osamu
• Granted Patent: US 8,785,491 B2
• Time in Patent Office: Days
• US Class Current: 424/133.1
• CPC Class Codes: A61K 31/343 condensed with a carbocyclic ring, e.g. coumaran, bufuralol, befunolol, clobenfurol, amiodarone
• CPC Class Codes: A61K 41/0057 Photodynamic therapy with a photosensitizer, i.e. agent able to produce reactive oxygen species upon exposure to light or radiation, e.g. UV or visible light; photocleavage of nucleic acids with an agent
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61N 5/062 Photodynamic therapy, i.e. excitation of an agent
• CPC Class Codes: A61P 27/02 Ophthalmic agents
• CPC Class Codes: C07D 307/93 condensed with a ring other than six-membered

Abstract

Pharmaceutical compositions and methods for treating and/or preventing age-related macular degeneration with melatonin analogues are provided.

Claims

1. A method for treating and/or preventing age-related macular degeneration in a patient identified as in need thereof, wherein said method comprises identifying a patient in need of treatment for age-related macular degeneration, and administering a therapeutic amount of ramelteon to said patient.

2. The method of claim 1, wherein the patient is identified by visual examination of the patient'"'"'s eye.

3. The method of claim 1, wherein the patient is identified by screening according to risk-factor criteria.

4. The method of claim 1 wherein said age-related macular degeneration is the dry form.

5. The method of claim 1 wherein said age-related macular degeneration is the wet form.

6. The method of claim 1 wherein said age-related macular degeneration occurs in one eye.

7. The method of claim 1 wherein said age-related macular degeneration occurs in two eyes.

8. The method of claim 1 wherein said administration of ramelteon is by an oral dosage form.

9. The method of claim 1 wherein said administration of ramelteon is by an injectible dosage form.

10. The method of claim 1 wherein said administration of ramelteon is by a surface absorbent dosage form.

11. The method of claim 10 wherein said administration of ramelteon is by a skin-patch dosage form.

12. The method of claim 10 wherein said administration of ramelteon is by a liquid, powder, ointment, paste, gel or cream dosage form.

13. The method of claim 1 wherein said ramelteon is administered in a dose of from 1 mg to 1000 mg.

14. The method of claim 1 wherein said ramelteon is administered in the form of an isolated metabolite of ramelteon, (S)—

N-[2-[4-hydroxy-1,6,7,8-tetrahydro-2H-indeno[5,4-b]furan-8-yl]ethyl]propionamide, in a dose of from 1 mg to 1000 mg.

15. The method of claim 1 wherein administration of a therapeutic amount of ramelteon results in a serum concentration of (S)—

N-[2-[4-hydroxy-1,6,7,8-tetrahydro-2H-indeno[5,4-b]furan-8-yl]ethyl]propionamide of from 1 μ

g/L to 100 mg/L.

16. The method of claim 1 wherein said ramelteon is administered in a dose once daily.

17. The method of claim 16 wherein said ramelteon is administered in the evening.

18. The method of claim 16 wherein said ramelteon is administered prior to sleep.

19. The method of claim 1 wherein said ramelteon is administered in a dose twice daily.

20. The method of claim 1 wherein said ramelteon is administered in a dose more than twice daily.

21. The method of claim 19 wherein administration of a therapeutic amount of ramelteon results in a serum concentration of (S)—

N-[2-[4-hydroxy-1,6,7,8-tetrahydro-2H-indeno[5,4-b]furan-8-yl]ethyl]propionamide of from 1 μ

g/L to 100 mg/L.

22. The method of claim 20 wherein administration of a therapeutic amount of ramelteon results in a serum concentration of (S)—

N-[2-[4-hydroxy-1,6,7,8-tetrahydro-2H-indeno[5,4-b]furan-8-yl]ethyl]propionamide of from 1 μ

g/L to 100 mg/L.

23. The method of claim 1 further comprising administering photodynamic therapy.

24. The method of claim 1 further comprising administering a therapeutic amount of a pharmaceutical agent selected from the group consisting of bevacizumab, ranibizumab, melatonin, pegaptanib and combinations thereof.

25. A method for treating and/or preventing age-related macular degeneration in a patient identified as in need thereof, wherein said method comprises administering a therapeutic amount of ramelteon to a patient in need of treatment for age-related macular degeneration.

26. The method of claim 25 wherein said ramelteon is administered in the form of an isolated metabolite of ramelteon, (S)—

N-[2-[4-hydroxy-1,6,7,8-tetrahydro-2H-indeno[5,4-b]furan-8-yl]ethyl]propionamide, in a dose of from 1 mg to 1000 mg.

27. The method of claim 25 further comprising administering photodynamic therapy.

28. The method of claim 25 further comprising administering a therapeutic amount of a pharmaceutical agent selected from the group consisting of bevacizumab, ranibizumab, melatonin, pegaptanib sodium and combinations thereof.

29. A pharmaceutical composition comprising (S)—

N-[2-[4-hydroxy-1,6,7,8-tetrahydro-2H-indeno[5,4-b]furan-8-yl)ethyl]propionamide and a pharmacologically acceptable carrier.

30. (S)—

N-[2-[4-hydroxy-1,6,7,8-tetrahydro-2H-indeno[5,4-b]furan-8-yl]ethyl]propionamide.