IP Library Patent Application 14584985
Patent Application
App. No. 14/584,985

METHODS FOR TREATING VISCERAL FAT CONDITIONS

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Patent No.
US None
App. No.
14/584,985
Abstract

Disclosed are methods and compositions for treating visceral fat conditions and/or metabolic syndrome using combinations of naltrexone and bupropion.

Claims (62)

1 . Use of a first compound and a second compound in the preparation of a medicament for the treatment of a visceral fat condition in a person who has been identified or diagnosed as being in need of said treatment, wherein said first compound is naltrexone or a pharmaceutically acceptable salt thereof, and said second compound is bupropion or a pharmaceutically acceptable salt thereof.

2 . The use according to claim 1 , wherein said first compound is in an amount effective to enhance the treatment effect of said second compound compared to the administration of said second compound alone.

3 . The use according to claim 1 , wherein said second compound is in an amount effective to enhance the treatment effect of said first compound compared to the administration of said first compound alone.

4 . The use according to any of claims 1 to 3 , wherein said person has an amount of visceral fat that increases the risk and/or severity of at least one disease or condition selected from coronary heart disease, cancer, diabetes, glucose intolerance, hyperinsulinemia, hypertension, periodontal disease, and a metabolic syndrome.

5 . The use according to any of claims 1 to 3 , wherein said person has been identified or diagnosed using a method comprising the determination of a waist-to-hip measurement ratio.

6 . The use according to claim 5 , wherein said person has a waist-to-hip measurement ratio of about 0.8 or greater.

7 . The use according to any of claims 1 to 6 , wherein said person has been identified or diagnosed using a method comprising analyzing one or more test selected from a computed tomography (CT) scan, a magnetic resonance imaging scan, and an ultrasonogram.

8 . The use according to claim 7 , wherein the intra-abdominal fat area of said person, as determined by CT scanning in a single tomographic slice at the L 4 -L 5 level, is about 80 cm 2 or greater.

9 . The use according to any of claims 1 to 8 , wherein said person has metabolic syndrome.

10 . The use according to claim 9 , wherein said person has been identified or diagnosed using a method comprising identifying at least three patient characteristics selected from abdominal obesity, elevated triglyceride levels, decreased high-density lipoprotein (HDL) cholesterol levels, high blood pressure, and impaired fasting blood glucose.

11 . The use according to claim 10 , wherein one of said patient characteristics is abdominal obesity.

12 . The use according to any of claims 1 to 11 , wherein said treatment of a visceral fat condition comprises at least one effect selected from a reduction of abdominal obesity, a reduction of triglyceride levels, an increase of high-density cholesterol levels, a reduction in blood pressure, and an improvement in fasting blood glucose levels.

13 . The use according to any of claims 1 to 12 , wherein said treatment of a visceral fat condition comprises a reduction of said person's susceptibility to a heart disease.

14 . The use according to claim 13 , wherein said reduction of said person's susceptibility to a heart disease comprises a reduction of inflammation.

15 . The use according to claim 14 , wherein said reduction of inflammation comprises a reduction of the serum level of interleukin 6.

16 . The use according to claim 14 , wherein said reduction of inflammation comprises a reduction of the serum level of C-reactive protein.

17 . The use according to any of claims 1 to 16 , wherein said person is viscerally obese.

18 . The use according to any of claims 1 to 17 , wherein the body mass index of said person is greater than about 30.

19 . The use according to any of claims 1 to 17 , wherein the body mass index of said person is greater than about 40.

20 . The use according to any of claims 1 to 17 , wherein the body mass index of said person is less than about 30.

21 . The use according to any of claims 1 to 20 , wherein said first compound and said second compound are administered together in a single dosage form.

22 . The use according to any of claims 1 to 20 , wherein said first compound and said second compound are administered in separate dosage forms.

23 . The use according to claim 22 , wherein said first compound is administered prior to, concurrently with, or subsequent to said second compound.

24 . The use according to any of claims 1 to 23 , wherein the amount of said bupropion or pharmaceutically acceptable salt thereof is in the range of from about 100 mg to about 600 mg.

25 . The use according to any of claims 1 to 24 , wherein the amount of said naltrexone or pharmaceutically acceptable salt thereof is in the range of from about 4 mg to about 50 mg.

26 . The use according to any of claims 1 to 25 , wherein said naltrexone or pharmaceutically acceptable salt thereof is a sustained-release naltrexone or pharmaceutically acceptable salt thereof.

27 . The use according to any of claims 1 to 26 , wherein said bupropion or pharmaceutically acceptable salt thereof is a sustained-release bupropion or pharmaceutically acceptable salt thereof.

28 . A method of treating a visceral fat condition, comprising administering a first and a second compound to a person who has been identified or diagnosed as being in need of treatment for a visceral fat condition in order to treat said visceral fat condition, wherein said first compound is naltrexone or a pharmaceutically acceptable salt thereof, and said second compound is bupropion or a pharmaceutically acceptable salt thereof.

29 . The method of claim 28 , wherein said first compound is in an amount effective to enhance the treatment effect of said second compound compared to the administration of said second compound alone.

30 . The method of claim 28 , wherein said second compound is in an amount effective to enhance the treatment effect of said first compound compared to the administration of said first compound alone.

31 . The method of any of claims 28 to 30 , wherein said person has an amount of visceral fat that increases the risk and/or severity of at least one disease or condition selected from coronary heart disease, cancer, diabetes, glucose intolerance, hyperinsulinemia, hypertension, periodontal disease, and a metabolic syndrome.

32 . The method of any of claims 28 to 31 , wherein said person has been identified or diagnosed using a method comprising the determination of a waist-to-hip measurement ratio.

33 . The method of claim 32 , wherein said person has a waist-to-hip measurement ratio of about 0.8 or greater.

34 . The method of any of claims 28 to 33 , wherein said person has been identified or diagnosed using a method comprising analyzing one or more test selected from a computed tomography (CT) scan, a magnetic resonance imaging scan, and an ultrasonogram.

35 . The method of claim 34 , wherein the intra-abdominal fat area of said person, as determined by CT scanning in a single tomographic slice at the L 4 -L 5 level, is about 80 cm 2 or greater.

36 . The method of any of claims 28 to 35 , wherein said person has metabolic syndrome.

37 . The method of claim 36 , wherein said person has been identified or diagnosed using a method comprising identifying at least three patient characteristics selected from abdominal obesity, elevated triglyceride levels, decreased high-density lipoprotein (HDL) cholesterol levels, high blood pressure, and impaired fasting blood glucose.

38 . The method of claim 37 , wherein one of said patient characteristics is abdominal obesity.

39 . The method of any of claims 28 to 38 , wherein said treatment of a visceral fat condition comprises at least one effect selected from a reduction of abdominal obesity, a reduction of triglyceride levels, an increase of high-density cholesterol levels, a reduction in blood pressure, and an improvement in fasting blood glucose levels.

40 . The method of any of claims 28 to 39 , wherein said treatment of a visceral fat condition comprises a reduction of said person's susceptibility to a heart disease.

41 . The method of claim 40 , wherein said wherein said reduction of said person's susceptibility to a heart disease comprises a reduction of inflammation.

42 . The method of claim 41 , wherein said reduction of inflammation comprises a reduction of the serum level of interleukin 6.

43 . The method of claim 41 , wherein said reduction of inflammation comprises a reduction of the serum level of C-reactive protein.

44 . The method of any of claims 28 to 43 , wherein said person is viscerally obese.

45 . The method of any of claims 28 to 44 , wherein the body mass index of said person is greater than about 30.

46 . The method of any of claims 28 to 44 , wherein the body mass index of said person is greater than about 40.

47 . The method of any of claims 28 to 44 , wherein the body mass index of said person is less than about 30.

48 . The method of any of claims 28 to 47 , wherein said first compound and said second compound are administered together in a single dosage form.

49 . The method of any of claims 28 to 47 , wherein said first compound and said second compound are administered in separate dosage forms.

50 . The method of claim 49 , wherein said first compound is administered prior to, concurrently with, or subsequent to said second compound.

51 . The method of any of claims 28 to 50 , wherein the amount of said bupropion or pharmaceutically acceptable salt thereof is in the range of from about 100 mg to about 600 mg.

52 . The method of any of claims 28 to 51 , wherein the amount of said naltrexone or pharmaceutically acceptable salt thereof is in the range of from about 4 mg to about 50 mg.

53 . The method of any of claims 28 to 52 , wherein said naltrexone or pharmaceutically acceptable salt thereof is a sustained-release naltrexone or pharmaceutically acceptable salt thereof.

54 . The method of any of claims 28 to 53 , wherein said bupropion or pharmaceutically acceptable salt thereof is a sustained-release bupropion or pharmaceutically acceptable salt thereof.

55 . A pharmaceutical composition for the treatment of a visceral fat condition in a person who has been identified or diagnosed as being in need of said treatment, said pharmaceutical composition comprising a first compound, wherein said first compound is naltrexone or a pharmaceutically acceptable salts thereof, and a second compound, wherein said second compound is bupropion or a pharmaceutically acceptable salt thereof.

56 . The pharmaceutical composition of claim 55 , wherein said first compound and said second compound are in a single dosage form.

57 . The pharmaceutical composition of claim 55 or 56 , wherein said first compound and said second compound in separate dosage forms.

58 . The pharmaceutical composition of claim 57 , wherein said first compound is administered prior to, concurrently with, or subsequent to said second compound.

59 . The pharmaceutical composition of any of claims 55 to 58 , wherein said composition comprises from about 100 mg to about 600 mg of said bupropion or pharmaceutically acceptable salt thereof.

60 . The pharmaceutical composition of any of claims 55 to 59 , wherein the amount of said naltrexone or pharmaceutically acceptable salt thereof is in the range of from about 4 mg to about 50 mg.

61 . The pharmaceutical composition of any of claims 55 to 60 , wherein said naltrexone or pharmaceutically acceptable salt thereof is a sustained-release naltrexone or pharmaceutically acceptable salt thereof.

62 . The pharmaceutical composition of any of claims 55 to 61 , wherein said bupropion or pharmaceutically acceptable salt thereof is a sustained-release bupropion or pharmaceutically acceptable salt thereof.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 22, 2017
From: DEWITT, DAVID
To: OREXIGEN THERAPEUTICS, INC.
Reel/Frame 041688/0910 →
SECURITY AGREEMENT Recorded Mar 21, 2016
From: OREXIGEN THERAPEUTICS, INC.
To: U.S. BANK NATIONAL ASSOCIATION, AS COLLATERAL AGENT
Reel/Frame 038180/0021 →