Exendin pharmaceutical compositions

• US 20040266692A1
• Filed: 07/20/2004
• Published: 12/30/2004
• Est. Priority Date: 08/08/1996
• Status: Active Grant

• Current Assignee: Astrazeneca Pharmaceuticals LP (Astrazeneca PLC)
• Original Assignee: Amylin Pharmaceuticals Incorporated (Bristol-Myers Squibb Company)
• Inventors: Young, Andrew A., Gedulin, Bronislava
• Granted Patent: US 7,521,423 B2
• Time in Patent Office: Days
• US Class Current: 514/7.3
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 38/00 Medicinal preparations containing peptides peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00
• CPC Class Codes: A61K 38/22 Hormones derived from pro-opiomelanocortin, pro-enkephalin or pro-dynorphin A61K38/33, e.g. corticotropin A61K38/35
• CPC Class Codes: A61K 38/26 Glucagons
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 1/06 Anti-spasmodics, e.g. drugs for colics, esophagic dyskinesia
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: C07K 14/57563 Vasoactive intestinal peptide [VIP]; Related peptides
• CPC Class Codes: C07K 14/605 Glucagons

Abstract

Methods for reducing gastric motility and delaying gastric emptying for therapeutic and diagnostic purposes are disclosed which comprise administration of an effective amount of an exendin or an exendin agonist. Methods for treating conditions associated with elevated, inappropriate, or undesired post-prandial blood glucose levels are disclosed which comprise administration of an effective amount of an exendin or an exendin agonist alone or in conjunction with other anti-gastric emptying agents.

Claims

1. A method of beneficially regulating gastro-intestinal motility in a subject comprising administering to said subject a therapeutically effective amount of an exendin or an exendin agonist.

2. A method according to claim 1 wherein said beneficial regulation of gastrointestinal motility comprises reducing gastric motility.

3. A method according to claim 1 wherein said beneficial regulation of gastrointestinal motility comprises delaying gastric emptying.

4. The method according to claim 1, 2 or 3 wherein said exendin is exendin 3.

5. The method according to claim 1, 2 or 3 wherein said exendin agonist is exendin-4.

6. The method according to claim 1, 2 or 3 wherein said subject is undergoing a gastrointestinal diagnostic procedure.

7. The method of claim 6 wherein said gastro-intestinal diagnostic procedure is a radiological examination.

8. The method of claim 7 wherein said gastrointestinal diagnostic procedure is magnetic resonance imaging.

9. A method according to claim 1, 2 or 3 wherein said gastric motility is associated with a gastrointestinal disorder.

10. A method according to claim 9 wherein said gastrointestinal disorder is a spasm.

11. A method according to claim 10 wherein said spasm is associated with a disorder selected from the group consisting of acute diverticulitis or a disorder of the biliary tract or a disorder of the Sphincter of Oddi.

20. The method according to claim 1, 2 or 3 wherein said exendin agonist is selected from a peptide compound of the formula:

21. The method according to claim 1, 2 or 3 wherein said exendin agonist is selected from a peptide compound of the formula [SEQ. ID. NO. 36]:

12. A method of treating postprandial dumping syndrome in a subject comprising administering to said subject a therapeutic effective amount of an exendin or exendin agonist.

13. A method of treating postprandial hyperglycemia comprising administering a therapeutically effective amount of an exendin or exendin agonist.

14. The method according to claim 13 further comprising administering a therapeutically effective amount of an amylin or an amylin agonist.

15. The method according to claim 14 wherein said amylin agonist is ²⁵Pro, ²⁸Pro, ²⁹Pro-h-amylin.

16. A method of treating postprandial hyperglycemia which is a consequence of type 2 diabetes mellitus comprising administering a therapeutically effective amount of an exendin or an exendin agonist.

17. A method of treating type 1 diabetes mellitus comprising administering a therapeutically effective amount of an exendin or an exendin agonist.

18. A method of treating impaired glucose tolerance comprising administering a therapeutically effective amount of an exendin or an exendin agonist.

19. A method of treatment for ingestion of a toxin comprising;

(a) administering an amount of an exendin or an exendin agonist effective to prevent or reduce the passage of stomach contents to the intestines; and

(b) aspirating the contents of the stomach.