INTERMITTENT DOSING REGIMEN FOR OVERWEIGHT AND OBESE SUBJECTS

• US 20110059986A1
• Filed: 11/17/2010
• Published: 03/10/2011
• Est. Priority Date: 04/09/2004
• Status: Abandoned Application

• Current Assignee: Elanco Animal Health Ireland Limited
• Original Assignee: Elanco Animal Health Ireland Limited
• Inventors: Engelen, Marc Alois Celine Maria, Coleta Maria Ghislain Hoeben, Dagmar Theo
• Application Number:
  US12/947,960
• Publication Number:
  US 20110059986A1
• Time in Patent Office: Days
• US Class Current: 514/254.07
• CPC Class Codes: A61K 31/496 Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
• CPC Class Codes: A61P 1/18 for pancreatic disorders, e.g. pancreatic enzymes
• CPC Class Codes: A61P 19/02 for joint disorders, e.g. arthritis, arthrosis
• CPC Class Codes: A61P 3/04 Anorexiants; Antiobesity agents
• CPC Class Codes: A61P 3/06 Antihyperlipidemics
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 9/10 for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Abstract

The present invention concerns an intermittent dosing regimen for the treatment of obesity or the reduction of body weight wherein a pharmaceutical composition containing an apoB secretion/MTP inhibitor is administered to a subject in need thereof for a period of time, then withheld for a period of time, and again administered for a period of time. The intermittent regimen may be repeated depending on the response in the subject that is being sought.

Claims

1. An intermittent dosing regimen for the treatment of obesity or the reduction of body weight wherein a pharmaceutical composition containing an apoB secretion/MTP inhibitor as the active ingredient in a therapeutically effective amount is administered to a subject in need thereof for Aweeks-Bweeks-Cweeks wherein A ranges from 2 to 4 and represents the number of weeks during which a pharmaceutical composition containing an apoB secretion/MTP inhibitor as the active ingredient in a therapeutically effective amount is administered to a subject in need thereof, B ranges from 2 to 4 and represents the number of weeks during which administration is withheld, and C ranges from 2 to 4 and represents the number of weeks during which said pharmaceutical composition containing the apoB secretion/MTP inhibitor is again administered.

4. A regimen as claimed in claim 1 wherein Aweeks-Bweeks-Cweeks is selected from 4 w-4 w-4 w, 4 w-3 w-4 w, 4 w-2 w-4 w, 3 w-3 w-3 w, 3 w-2 w-3 w, and 2 w-2 w-2 w.

5. A regimen as claimed in claim 4 wherein Aweeks-Bweeks-Cweeks is 3 w-2 w-3 w.

6. A regimen according to claim 1 wherein the apoB secretion/MTP inhibitor is mitratapide.

7. A regimen according to claim 6 wherein mitratapide is administered in a daily amount ranging from 0.31 mg per kg body weight to 1.25 mg per kg body weight.

8. A regimen according to claim 7 which is combined with a maintenance diet having a caloric content equal to the caloric expenditure of the subject.

9. A regimen according to claim 8 wherein the subject is a companion animal.

16. A regimen as claimed in claim 1, wherein the regimen is for the reduction of body weight.

17. A regimen as claimed in claim 7, wherein mitratapide is administered in a daily amount of 0.63 mg per kg body weight.

18. A regimen according to claim 9, wherein the companion animal is a dog or a cat.

2-3. -3. (canceled)

10. A pharmaceutical kit comprising dosage forms for administration to a subject in need thereof on days 1 to 28 and on days 57 to 84;

or on days 1 to 28, and on days 50 to 77;

or on days 1 to 28, and on days 43 to 70;

or on days 1 to 21, and on days 43 to 63;

or on days 1 to 21, and on days 36 to 56;

or on days 1 to 14, and on days 29 to 42, which kit comprises dosage forms containing an apoB secretion/MTP inhibitor as the active ingredient in a therapeutically effective amount and a memory aid in the form of numbers or a calendar indicating on which days of the regimen the dosage forms should be ingested.

11. A method of treating obesity, comprising administering a pharmaceutical composition containing an apoB secretion/MTP inhibitor as the active ingredient in a therapeutically effective amount according to an intermittent Aweeks-Bweeks-Cweeks regimen wherein A ranges from 2 to 4 weeks and represents the number of weeks during which said pharmaceutical composition is administered to a subject in need thereof, B ranges from 2 to 4 weeks and represents the number of weeks during which administration is withheld, and C ranges from 2 to 4 weeks and represents the number of weeks during which said pharmaceutical composition is again administered.

12. The method according to claim 11 wherein Aweeks-Bweeks-Cweeks is selected from 4 w-4 w-4 w, 4 w-3 w-4 w, 4 w-2 w-4 w, 3 w-3 w-3 w, 3 w-2 w-3 w, and 2 w-2 w-2 w.

13. The method according to claim 12 wherein Aweeks-Bweeks-Cweeks is 3 w-2 w-3 w.

14. The method according to claim 11 wherein the apoB secretion/MTP inhibitor is mitratapide.

15. The method according to claim 14 wherein mitratapide is administered in a daily amount ranging from 0.31 mg per kg body weight to 1.25 mg per kg body weight.