Claims for Patent: 11,033,543

Summary for Patent: 11,033,543

Title:	Methods of providing weight loss therapy in patients with major depression
Abstract:	Disclosed are methods of providing weight loss therapy, particularly for patients suffering from major depression.
Inventor(s):	Dunayevich; Eduardo (Westlake Village, CA), Tollefson; Gary (Indianapolis, IN)
Assignee:	Nalpropion Pharmaceuticals LLC (Morristown, NJ)
Application Number:	16/441,863
Patent Claims:	1. A method for providing weight loss therapy to an overweight or obese patient suffering from major depressive disorder, comprising administering to the patient an amount of naltrexone or a pharmaceutically acceptable salt thereof in a range of about 4 mg to about 50 mg per day and an amount of bupropion or a pharmaceutically acceptable salt thereof in a range of about 30 mg to about 500 mg per day; wherein said method provides about the same amount of weight loss in overweight or obese patients who are suffering from major depressive disorder as in overweight or obese patients who are not suffering from major depressive disorder. 2. The method of claim 1, wherein the method provides a reduction in symptoms of depression in the patient. 3. The method of claim 1, wherein the patient is overweight. 4. The method of claim 1, wherein the patient is obese. 5. The method of claim 1, wherein the naltrexone or a pharmaceutically acceptable salt thereof and bupropion or a pharmaceutically acceptable salt thereof is administered once per day. 6. The method of claim 1, wherein the naltrexone or a pharmaceutically acceptable salt thereof and bupropion or a pharmaceutically acceptable salt thereof is administered more than once per day. 7. The method of claim 1, wherein the naltrexone or pharmaceutically acceptable salt thereof is administered prior to or subsequent to the bupropion or pharmaceutically acceptable salt thereof. 8. 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. 9. The method of claim 8, wherein the single oral dosage form further comprises a pharmaceutically acceptable excipient, diluent, or carrier. 10. The method of claim 1, wherein the amount of naltrexone or pharmaceutically acceptable salt thereof is about 16 mg or about 32 mg per day; and wherein the amount of bupropion or pharmaceutically acceptable salt thereof is about 360 mg per day. 11. The method of claim 1, wherein the initial daily dose administered to the patient is about 4 mg or about 8 mg of the naltrexone or pharmaceutically acceptable salt thereof and about 90 mg of the bupropion or pharmaceutically acceptable salt thereof; and wherein the daily dose administered to the patient for maintenance is about 16 mg or about 32 mg of the naltrexone or pharmaceutically acceptable salt thereof and about 360 mg of the bupropion or pharmaceutically acceptable salt thereof. 12. The method of claim 1, wherein the daily dose of the naltrexone or pharmaceutically acceptable salt thereof is a dosing schedule selected from the group consisting of 4 mg in week one to 8 mg in week two, 12 mg in week three, and 16 mg in week four and thereafter and 8 mg in week one to 16 mg in week two, 24 mg in week three, and 32 mg in week four and thereafter; and wherein the daily dose of the bupropion or pharmaceutically acceptable salt thereof is escalated from 90 mg in week one to 180 mg in week two, 270 mg in week three, and 360 mg in week four and thereafter. 13. The method of claim 12, wherein at least one of the naltrexone or pharmaceutically acceptable salt thereof and bupropion or pharmaceutically acceptable salt thereof is in a sustained release formulation. 14. The method of claim 13, wherein the naltrexone or pharmaceutically acceptable salt thereof and the bupropion or pharmaceutically acceptable salt thereof are in a single oral dosage form. 15. The method of claim 12, wherein each of the naltrexone or pharmaceutically acceptable salt thereof and bupropion or pharmaceutically acceptable salt thereof is in a sustained release formulation. 16. The method of claim 15, wherein the naltrexone or pharmaceutically acceptable salt thereof and the bupropion or pharmaceutically acceptable salt thereof are in a single oral dosage form. 17. The method of claim 1, wherein at least one of the naltrexone or pharmaceutically acceptable salt thereof and bupropion or pharmaceutically acceptable salt thereof is in a sustained release formulation. 18. The method of claim 1, wherein each of the naltrexone or pharmaceutically acceptable salt thereof and bupropion or pharmaceutically acceptable salt thereof is in a sustained release formulation. 19. A method for providing weight loss therapy to an overweight or obese patient suffering from major depressive disorder, comprising administering to the patient an amount of naltrexone or a pharmaceutically acceptable salt thereof and an amount of bupropion or a pharmaceutically acceptable salt thereof, wherein the amount of naltrexone or pharmaceutically acceptable salt thereof is about 32 mg per day; wherein the amount of bupropion or pharmaceutically acceptable salt thereof is about 360 mg per day; wherein each of naltrexone or pharmaceutically acceptable salt thereof and bupropion or pharmaceutically acceptable salt thereof is in a sustained release formulation, and said method provides about the same amount of weight loss in overweight or obese patients who are suffering from major depressive disorder as in overweight or obese patients who are not suffering from major depressive disorder.