Method and Means of Preventing and Treating Sleep Disordered Breathing

• US 20080261931A1
• Filed: 09/04/2006
• Published: 10/23/2008
• Est. Priority Date: 09/16/2005
• Status: Abandoned Application

• Current Assignee: Cereuscience AB
• Original Assignee: Cereuscience AB
• Inventors: Hedner, Jan, Grote, Ludger, Stenlof, Kaj
• Application Number:
  US12/066,994
• Publication Number:
  US 20080261931A1
• Time in Patent Office: Days
• US Class Current: 514/171
• CPC Class Codes: A61K 31/137 Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
• CPC Class Codes: A61K 31/16 Amides, e.g. hydroxamic acids
• CPC Class Codes: A61K 31/424 condensed with heterocyclic ring systems, e.g. clavulanic acid
• CPC Class Codes: A61K 31/433 Thidiazoles
• CPC Class Codes: A61K 31/454 containing a five-membered ring with nitrogen as a ring hetero atom, e.g. pimozide, domperidone
• CPC Class Codes: A61K 31/522 having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
• CPC Class Codes: A61K 31/57 substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
• CPC Class Codes: A61K 31/7004 Monosaccharides having only carbon, hydrogen and oxygen atoms
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 3/04 Anorexiants; Antiobesity agents
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

A method of treating or preventing snoring, obstructive sleep apnea (OSA) and/or central sleep apnea (CSA) comprises administering a pharmacologically effective amount a salt of acetylhomotaurine (AcHT) such as calcium acamprosate (CA) to a patient. Also disclosed is the use of AcHT and CA for the manufacture of a medicament for treating or preventing snoring, OSA and/or CSA and of a diagnostic device, kit or composition; a protective patch comprising AcHT or CA; and a pharmaceutical composition comprising AcHT or CA and an agent capable of alleviating the effects of snoring OSA and/or CSA, in combined amounts effective in the treatment of snoring OSA and/or CSA, and a carrier.

Claims

1. A method of treating or preventing snoring, obstructive sleep apnea (OSA) or central sleep apnea (CSA) or both, comprising administering a pharmacologically effective amount a pharmaceutically acceptable salt of acetylhomotaurine to a patient in need thereof, with the proviso that treatment or prevention of snoring, sleep apnea, and sleep disordered breathing caused by external mechanical obstruction of the airways is excluded.

2. The method of claim 1, wherein said therapeutically effective dose is such as to be effective during a substantial portion of a single sleep period.

3. The method of claim 2, wherein said substantial portion is 20% or more of said sleep period.

4. The method of claim 2, wherein said substantial portion is 80% or more of said sleep period.

5. The method of claim 2, wherein said single sleep period is from thirty minutes to twelve hours.

6. The method of claim 1, wherein the administration is peroral.

7. The method of claim 6, wherein the administration is sublingual.

8. The method of claim 1, wherein the administration is topical.

9. The method of claim 6, wherein the administration is confined to the frontal portion of the neck and the breast.

10. The method of claim 6, wherein the therapeutically active dose is sustainedly released over a period of time extending from 1 hour to 12 hours.

11. The method of claim 1, wherein from 50% to 100% of said therapeutically effective dose is released within a period of three hours from administration.

12. The method of claim 1, wherein from 80% to 100% of said therapeutically effective dose is released within a period of five hours from administration.

13. The method of claim 10, wherein said therapeutically effective dose is from 100 to 4000 mg.

26. method of claim 1, wherein the pharmaceutically acceptable salt of acetylhomotaurine is calcium acamprosate.

14-21. -21. (canceled)

22. A protective patch comprising a pharmaceutically acceptable salt of acetylhomotaurine in an amount therapeutically effective in the treatment of snoring OSA and/or CSA and a pharmaceutically acceptable carrier for transdermal or transmucosal administration.

28. The patch according to claim 22 in which the pharmaceutically acceptable salt of acetylhomotaurine is calcium acamprosate.

23. (canceled)

24. A pharmaceutical composition comprising a pharmaceutically acceptable salt of acetylhomotaurine, and a different agent capable of alleviating the effects of snoring OSA and/or CSA, in combined amounts effective in the treatment of snoring OSA and/or CSA, and a pharmaceutically acceptable carrier.

25. The composition of claim 24, wherein said agent is selected from the group consisting of sibutramine, topiramate, zonisamide, orlistate, rimonabant, acetazolamide, an agent influencing serotoninergic neurotransmission, tricyclic antidepressant, theophylline, progesterone and cholinesterase inhibitor.

27. The composition according to claim 24 in which the pharmaceutically acceptable salt of acetylhomotaurine is calcium acamprosate.