Combination Therapies for the Treatment of Obesity

• US 20110082407A1
• Filed: 10/01/2010
• Published: 04/07/2011
• Est. Priority Date: 10/01/2009
• Status: Abandoned Application

• Current Assignee: Metabolous Pharmaceuticals, Inc.
• Original Assignee: Metabolous Pharmaceuticals, Inc.
• Inventors: Aronne, Louis J.
• Application Number:
  US12/896,040
• Publication Number:
  US 20110082407A1
• Time in Patent Office: Days
• US Class Current: 604/8
• CPC Class Codes: A61F 5/0036 Intragastrical devices
• 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 31/00 Medicinal preparations containing organic active ingredients
• CPC Class Codes: A61K 31/137 Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
• CPC Class Codes: A61K 31/155 Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
• CPC Class Codes: A61K 31/35 having six-membered rings with one oxygen as the only ring hetero atom
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 1/16 for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 15/00 Drugs for genital or sexual disorders for disorders of sex hormones A61P5/24; Contraceptives
• CPC Class Codes: A61P 15/08 for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
• CPC Class Codes: A61P 19/02 for joint disorders, e.g. arthritis, arthrosis
• CPC Class Codes: A61P 25/20 Hypnotics; Sedatives
• CPC Class Codes: A61P 25/22 Anxiolytics
• CPC Class Codes: A61P 25/24 Antidepressants
• CPC Class Codes: A61P 3/00 Drugs for disorders of the metabolism of the blood or the extracellular fluid A61P7/00
• 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 35/00 : Antineoplastic agents
• CPC Class Codes: A61P 9/00 : Drugs for disorders of the cardiovascular system
• CPC Class Codes: A61P 9/12 : Antihypertensives

Abstract

Described are pharmaceutical compositions comprising topiramate, phentermine, and metformin, and at least one pharmaceutically acceptable carrier or excipient. Another aspect of the present invention relates to a method of treating a patient suffering from obesity or needing to lose weight, comprising the step of co-administering to said patient a therapeutically effective amount of topiramate, phentermine, and metformin. In certain embodiments, an aforementioned method is practiced in conjunction or tandem with a medical procedure or the use of a medical device or both.

Claims

1. A pharmaceutical composition comprising topiramate, phentermine, and metformin, or pharmaceutically acceptable salts or solvates of any of them;

and at least one pharmaceutically acceptable carrier or excipient.

2. The pharmaceutical composition of claim 1, wherein the amount of topiramate is about 10 mg to about 110 mg.

3. The pharmaceutical composition of claim 1, wherein the amount of topiramate is about 10-15 mg, about 20-30 mg, about 40-60 mg, about 60-90 mg, or about 90-110 mg.

4. The pharmaceutical composition of claim 1, wherein the amount of topiramate is about 12.5 mg, about 25 mg, about 50 mg, about 75 mg, or about 100 mg.

5. The pharmaceutical composition of claim 1, wherein the amount of phentermine is about 5.0 mg to about 42.5 mg.

6. The pharmaceutical composition of claim 1, wherein the amount of phentermine is about 5.0-10.0 mg, about 12.5-17.5 mg, about 15-22 mg, about 20-30 mg, about 25-35 mg, or about 32.5-42.5 mg.

7. The pharmaceutical composition of claim 1, wherein the amount of phentermine is about 7.5 mg, about 15 mg, about 18.75 mg, about 25 mg, about 30 mg, or about 37.5 mg.

8. The pharmaceutical composition of claim 1, wherein the amount of metformin is about 225 mg to about 2200 mg.

9. The pharmaceutical composition of claim 1, wherein the amount of metformin is about 225-275 mg, about 450-550 mg, about 700-800 mg, about 900-1100 mg, about 1350-1650 mg, or about 1800-2200 mg.

10. The pharmaceutical composition of claim 1, wherein the amount of metformin is about 250 mg, about 500 mg, about 750 mg, about 1000 mg, about 1500 mg, or about 2000 mg.

11. A method of treating obesity or achieving weight loss, comprising the step of co-administering to a subject in need thereof a therapeutically effective amount of topiramate, phentermine, and metformin, or pharmaceutically acceptable salts or solvates of any of them.

12. The method of claim 11, wherein topiramate is administered once or twice daily.

13. The method of claim 11, wherein phentermine is administered once or twice daily.

14. The method of claim 11, wherein metformin is administered once or twice daily.

15. The method of claim 11, wherein about 10 mg to about 110 mg of topiramate is administered.

16. The method of claim 11, wherein about 10-15 mg, about 20-30 mg, about 40-60 mg, about 60-90 mg, or about 90-110 mg of topiramate is administered.

17. The method of claim 11, wherein about 12.5 mg, about 25 mg, about 50 mg, about 75 mg, or about 100 mg of topiramate is administered.

18. The method of claim 11, wherein about 5.0 mg to about 42.5 mg of phentermine is administered.

19. The method of claim 11, wherein about 5.0-10.0 mg, about 12.5-17.5 mg, about 15-22 mg, about 20-30 mg, about 25-35 mg, or about 32.5-42.5 mg of phentermine is administered.

20. The method of claim 11, wherein about 7.5 mg, about 15 mg, about 18.75 mg, about 25 mg, about 30 mg, or about 37.5 mg of phentermine is administered.

21. The method of claim 11, wherein about 225 mg to about 2200 mg of metformin is administered.

22. The method of claim 11, wherein about 225-275 mg, about 450-550 mg, about 700-800 mg, about 900-1100 mg, about 1350-1650 mg, or about 1800-2200 mg of metformin is administered.

23. The method of claim 11, wherein about 250 mg, about 500 mg, about 750 mg, about 1000 mg, about 1500 mg, or about 2000 mg of metformin is administered.

24. The method of claim 11, wherein

a dose of topiramate is administered once daily;

the dose of topiramate is about 25 mg of topiramate;

a dose of phentermine is administered once daily;

the dose of phentermine is about 15 mg of phentermine;

a dose of metformin is administered once daily; and

the dose of metformin is about 500 mg of metformin.

25. The method of claim 11, wherein

a dose of topiramate is administered once daily;

the dose of topiramate is about 25 mg of topiramate;

a dose of phentermine is administered once daily;

the dose of phentermine is about 18.75 mg of phentermine;

a dose of metformin is administered once daily; and

the dose of metformin is about 500 mg of metformin.

26. The method of claim 11, wherein

a dose of topiramate is administered once daily;

the dose of topiramate is about 75 mg of topiramate;

a dose of phentermine is administered once daily;

the dose of phentermine is about 18.75 mg of phentermine;

a dose of metformin is administered once daily; and

the dose of metformin is about 500 mg of metformin.

27. The method of claim 11, wherein

a dose of topiramate is administered once daily;

the dose of topiramate is about 100 mg of topiramate;

a dose of phentermine is administered once daily;

the dose of phentermine is about 18.75 mg of phentermine;

a dose of metformin is administered twice daily; and

each dose of metformin is about 500 mg of metformin.

28. The method of claim 11, further comprising the step of treating the subject with a medical device.

29. The method of claim 11, further comprising the step of treating the subject with a medical device, wherein the medical device is selected from the group consisting of an endoluminal sleeve, an intragastric balloon, a fastener, a gastric pacemaker, and an electrical device.

30. The method of claim 11, further comprising the step of completing a medical procedure on the subject.

31. The method of claim 11, further comprising the step of completing a medical procedure on the subject;

wherein the medical procedure is a restrictive procedure, a malabsorptive procedure, or a body-contouring procedure.

32. A method of treating a malady, comprising the step of co-administering to a subject in need thereof a therapeutically effective amount of topiramate, phentermine, and metformin, or pharmaceutically acceptable salts or solvates of any of them, wherein the malady is selected from the group consisting of type 2 diabetes, shortness of breath, gallbladder disease, hypertension, elevated blood cholesterol levels, endometrial cancer, breast cancer, prostate cancer, colon cancer, osteoarthritis, other orthopedic problems, reflux esophagitis, snoring, menstrual irregularities, infertility, heart trouble, dyslipidemia, coronary heart disease, stroke, hyperinsulinemia, depression, anxiety, gout, fatty liver disease, insulin resistance, pre-diabetes, beta-cell dysfunction, sleep apnea, obstructive sleep apnea, hypopnea, and visceral adiposity.