Combination therapy for effecting weight loss and treating obesity

• US 7,659,256 B2
• Filed: 03/20/2006
• Issued: 02/09/2010
• Est. Priority Date: 06/14/1999
• Status: Expired due to Fees

• Current Assignee: Vivus Incorporated
• Original Assignee: Vivus Incorporated
• Inventors: Najarian, Thomas
• Primary Examiner(s): Maier; Leigh C
• Application Number:
  US11/385,199
• Publication Number:
  US 20060234951A1
• Time in Patent Office: 1,422 Days
• Field of Search: None
• US Class Current: 514/23
• 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 31/137 Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
• CPC Class Codes: A61K 31/255 of sulfoxy acids or sulfur analogues thereof
• CPC Class Codes: A61K 31/35 having six-membered rings with one oxygen as the only ring hetero atom
• CPC Class Codes: A61K 31/36 Compounds containing methylenedioxyphenyl groups, e.g. sesamin
• CPC Class Codes: A61K 31/535 having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
• CPC Class Codes: A61K 31/7024 Esters of saccharides

Abstract

The present invention features a novel therapy for effecting weight loss which involves treating a subject with a sympathomimetic agent (e.g., phentermine or a phentermine-like drug) in combination with an anticonvulsant sulfamate derivative (e.g., topiramate) such that the subject experiences weight loss.

The combination methods of the present invention also are effective against symptoms associated with Syndrome X. The invention also features pharmaceutical compositions and kits for use in the practice of these novel therapies.

Claims

1. A method for effecting weight loss in a subject comprising administering to the subject a combination of:

(a) a therapeutically effective amount of phentermine, and (b) a therapeutically effective amount of an anticonvulsant sulfamate derivative having the structure of formula I

2. The method of claim 1, wherein X is O, R₁ is H, R₂ and R₃ taken together form the methylene dioxy linkage —

O—

CH₂—

O—

, R₄ and R₅ taken together form the methylene dioxy linkage —

O—

CH₂—

O—

, and the anticonvulsant sulfamate derivative is topiramate.

3. The method of claim 2, wherein the therapeutically effective amount of phentermine is from 5 to 60 mg daily.

4. The method of claim 2, wherein the therapeutically effective amount of topiramate is from 50 to 1500 mg daily.

5. The method of claim 4, wherein the therapeutically effective amount of topiramate is less than 400 mg daily.

6. The method of claim 5, wherein the therapeutically effective amount of topiramate is from 50 to 400 mg daily.

7. The method of claim 2, wherein the therapeutically effective amount of phentermine is 15 mg daily.

8. The method of claim 7, wherein the therapeutically effective amount of topiramate is from 50 to 1500 mg daily.

9. The method of claim 8, wherein the therapeutically effective amount of topiramate is less than 400 mg daily.

10. The method of claim 9, wherein the therapeutically effective amount of topiramate is from 50 to 400 mg daily.

11. The method of claim 1, wherein the subject is overweight.

12. The method of claim 1, wherein the subject is obese.

13. The method of claim 1, wherein the subject is neither overweight nor obese.

14. The method of claim 1, wherein the subject suffers from a condition that can be alleviated with loss of body weight.

15. The method of claim 1, wherein the phentermine and the anti-convulsant sulfamate derivative are administered simultaneously.

16. The method of claim 15, wherein the phentermine amine and the anti-convulsant sulfamate derivative are administered in a single pharmaceutical formulation.

17. The method of claim 1, wherein the phentermine and the anti-convulsant sulfamate derivative are administered separately.

18. The method of claim 17, wherein the phentermine and the anti-convulsant sulfamate derivative are administered at different times of day.

19. The method of claim 18, wherein the phentermine is administered in the morning and the anti-convulsant sulfamate derivative is administered at least once later in the day.

20. The method of claim 2, wherein the phentermine and the topiramate are administered simultaneously.

21. The method of claim 20, wherein the phentermine and the topiramate are contained in a single pharmaceutical formulation.

22. The method of claim 2, wherein the phentermine and the topiramate are administered separately.

23. The method of claim 22, wherein the phentermine and the topiramate are administered at different times of the day.

24. The method of claim 23, wherein the phentermine is administered in the morning and the topiramate is administered at least once later in the day.

25. The method of claim 2, wherein the amount of topiramate administered to the subject is gradually increased, over an extended time period, from an initial daily dosage up to a final daily dosage suitable for continued therapy.

26. The method of claim 2, wherein the phentermine is contained in an immediate release dosage form.

27. The method of claim 26, wherein the topiramate is contained in an immediate release dosage form or a controlled release dosage form.

28. The method of claim 2, wherein the phentermine and the topiramate are administered orally.

29. A pharmaceutical composition comprising topiramate and phentermine.