IP Library › Granted Patent US 9,457,005
Granted Patent B2
US 9,457,005 · App. 14/326,075 · Granted Oct 4, 2016

Compositions and methods for increasing insulin sensitivity

Inventors: Michael A. Cowley (Portland, OR); Anthony A. McKinney (San Diego, CA); Gary Tollefson (Indianapolis, IN)
Assignee: OREXIGEN THERAPEUTICS, INC.
A61K31/35A61K31/135A61K31/138A61K31/423A61K31/445A61K31/4525A61K31/485A61K31/519A61K31/5415A61K31/55A61K31/551A61K31/554A61K31/5513A61K31/7048A61K38/28A61K45/06
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Quick Facts
Patent No.
US 9,457,005
App. No.
14/326,075
Granted
Oct 4, 2016
Kind
B2
Abstract

Methods and compositions for treating a blood glucose condition involve identifying a suitable subject and administering an effective amount of a composition that contains one or more of an opioid antagonist, an anticonvulsant, and a psychotherapeutic agent. The compositions can include insulin. In some embodiments, such methods and compositions can be used to modulate a blood glucose level. In preferred embodiments, such methods and compositions are useful for increasing a subject's sensitivity to insulin.

Claims (25)

1. A method of treating insulin resistance, comprising:

identifying a subject having a blood-glucose condition characterized by insulin resistance in need of treatment, wherein the condition is Type 2 diabetes and the subject is treated with insulin; and

administering to the subject an amount of a composition that is effective to treat the insulin resistance, wherein the composition comprises naltrexone or a pharmaceutically acceptable salt thereof and bupropion or a pharmaceutically acceptable salt thereof, wherein the amount of the naltrexone or pharmaceutically acceptable salt thereof is about 25 mg per day to about 50 mg per day, and wherein the amount of the bupropion or pharmaceutically acceptable salt thereof is about 200 mg per day to about 400 mg per day;

obtaining a measurement of the subject's blood glucose level following treatment with said composition; and

decreasing the amount of insulin used in the insulin treatment in response to the measurement of the subject's blood glucose level following treatment with said composition.

2. The method of claim 1 , wherein the naltrexone or pharmaceutically acceptable salt thereof is administered to the subject separately from the bupropion or pharmaceutically acceptable salt thereof.

3. The method of claim 1 , further comprising providing dietary instructions to the subject.

4. The method of claim 1 , wherein at least one of the naltrexone or pharmaceutically acceptable salt thereof and the bupropion or pharmaceutically acceptable salt thereof is in a sustained release formulation.

5. The method of claim 1 , wherein each of the naltrexone or pharmaceutically acceptable salt thereof and the bupropion or pharmaceutically acceptable salt thereof is in a sustained release formulation.

6. The method of claim 1 , wherein the naltrexone or pharmaceutically acceptable salt thereof and the bupropion or pharmaceutically acceptable salt thereof are in a single oral dosage form.

7. The method of claim 6 , wherein the single oral dosage form is in the form of a tablet, pill, or capsule.

8. A method of treating insulin resistance, comprising:

identifying a subject having a blood-glucose condition characterized by insulin resistance in need of treatment, wherein the condition is Type 2 diabetes and the subject is treated with insulin; and

administering to the subject an amount of a composition that is effective to treat the insulin resistance, wherein the composition comprises a sustained-release naltrexone formulation and a sustained-release bupropion formulation or pharmaceutically acceptable salts thereof, wherein the amount of the naltrexone or pharmaceutically acceptable salt thereof is about 25 mg per day to about 50 mg per day, and wherein the amount of the bupropion or pharmaceutically acceptable salt thereof is about 200 mg per day to about 400 mg per day, and wherein the composition is in a single oral dosage form;

obtaining a measurement of the subject's blood glucose level following treatment with said composition; and

decreasing the amount of insulin used in the insulin treatment in response to the measurement of the subject's blood glucose level following treatment with said composition.

9. The method of claim 8 , wherein the single oral dosage form is in the form of a tablet, pill, or capsule.

10. The method of claim 1 , wherein the amount of the naltrexone or pharmaceutically acceptable salt thereof is about 25 mg per day to about 38 mg per day, and wherein the amount of the bupropion or pharmaceutically acceptable salt thereof is about 300 mg per day to about 400 mg per day.

11. The method of claim 10 , wherein the subject is obese.

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

13. The method of claim 8 , wherein the amount of the naltrexone or pharmaceutically acceptable salt thereof is about 25 mg per day to about 38 mg per day, and wherein the amount of the bupropion or pharmaceutically acceptable salt thereof is about 300 mg per day to about 400 mg per day.

14. The method of claim 13 , wherein the subject is obese.

15. The method of claim 8 , wherein the subject is obese.

16. The method of claim 1 , wherein said amount of bupropion or pharmaceutically acceptable salt thereof is in a divided dose for administration twice a day, and wherein said amount of naltrexone or pharmaceutically acceptable salt thereof is in a divided dose for administration twice a day.

17. The method of claim 9 , wherein said amount of bupropion or pharmaceutically acceptable salt thereof is in a divided dose for administration twice a day, and wherein said amount of naltrexone or pharmaceutically acceptable salt thereof is in a divided dose for administration twice a day.

Assignments (8)
RELEASE OF SECURITY INTEREST Recorded Jul 1, 2026
From: WILMINGTON SAVINGS FUND SOCIETY, FSB
To: CURRAX PHARMACEUTICALS LLC; NALPROPION PHARMACEUTICALS LLC
Reel/Frame 075874/0883 →
RELEASE OF SECURITY INTEREST Recorded Jun 26, 2026
From: U.S. BANK NATIONAL ASSOCIATION
To: NALPROPION PHARMACEUTICALS LLC
Reel/Frame 075832/0043 →
SECURITY INTEREST Recorded Dec 19, 2019
From: CURRAX PHARMACEUTICALS LLC; NALPROPION PHARMACEUTICALS LLC
To: WILMINGTON SAVINGS FUND SOCIETY, FSB
Reel/Frame 051377/0958 →
CHANGE OF NAME Recorded Oct 17, 2019
From: NALPROPION PHARMACEUTICALS, INC.
To: NALPROPION PHARMACEUTICALS LLC
Reel/Frame 050750/0497 →
RELEASE OF SECURITY INTEREST Recorded Sep 27, 2019
From: WILMINGTON SAVINGS FUND SOCIETY, FSB
To: NALPROPION PHARMACEUTICALS, INC.
Reel/Frame 050574/0106 →
SECURITY INTEREST Recorded Aug 6, 2018
From: NALPROPION PHARMACEUTICALS, INC.
To: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS COLLATERAL AGENT
Reel/Frame 047288/0321 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 22, 2017
From: COWLEY, MICHAEL A; MCKINNEY, ANTHONY A.; TOLLEFSON, GARY
To: OREXIGEN THERAPEUTICS, INC.
Reel/Frame 041688/0886 →
SECURITY AGREEMENT Recorded Mar 21, 2016
From: OREXIGEN THERAPEUTICS, INC.
To: U.S. BANK NATIONAL ASSOCIATION, AS COLLATERAL AGENT
Reel/Frame 038180/0021 →
Continuity (4)
Continuation 11602571 · Nov 21, 2006
Provisional Application 60759117 · Jan 12, 2006
Provisional Application 60738893 · Nov 22, 2005
Related Publication 20140323399A1 · Oct 30, 2014