US2021299119A1PendingUtilityA1

Methods Of Providing Weight Loss Therapy In Patients With Major Depression

Assignee: NALPROPION PHARMACEUTICALS LLCPriority: Jan 11, 2010Filed: Jun 14, 2021Published: Sep 30, 2021
Est. expiryJan 11, 2030(~3.5 yrs left)· nominal 20-yr term from priority
A61K 31/485A61P 3/04A61K 31/439A61K 9/0053A61K 31/137A61K 2300/00A61K 31/44Y10S514/91Y10S514/909
71
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Claims

Abstract

Disclosed are methods of providing weight loss therapy, particularly for patients suffering from major depression.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A method for providing weight loss therapy to a patient, comprising:
 identifying a patient suffering from major depressive disorder, wherein the patient is also overweight or obese; and   reducing weight of the patient by administering to the patient naltrexone or a pharmaceutically acceptable salt thereof and bupropion or a pharmaceutically acceptable salt thereof, wherein the naltrexone or pharmaceutically acceptable salt thereof is in an amount effective to enhance the weight loss activity of the bupropion or pharmaceutically acceptable salt thereof.   
     
     
         2 . The method of  claim 1 , further comprising reducing 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 the naltrexone or pharmaceutically acceptable salt thereof is about 4 mg to about 50 mg per day; and wherein the amount of the bupropion or pharmaceutically acceptable salt thereof is about 30 mg to about 500 mg per day. 
     
     
         11 . 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. 
     
     
         12 . 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. 
     
     
         13 . 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. 
     
     
         14 . The method of  claim 13 , 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. 
     
     
         15 . The method of  claim 14 , wherein the naltrexone or pharmaceutically acceptable salt thereof and the bupropion or pharmaceutically acceptable salt thereof are in a single oral dosage form. 
     
     
         16 . The method of  claim 13 , wherein each of the naltrexone or pharmaceutically acceptable salt thereof and bupropion or pharmaceutically acceptable salt thereof is in a sustained release formulation. 
     
     
         17 . The method of  claim 16 , wherein the naltrexone or pharmaceutically acceptable salt thereof and the bupropion or pharmaceutically acceptable salt thereof are in a single oral dosage form. 
     
     
         18 . 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. 
     
     
         19 . 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. 
     
     
         20 . A method for providing weight loss therapy to a patient, comprising:
 identifying a patient suffering from major depressive disorder, wherein the patient is also overweight or obese; and   reducing weight of the patient by administering to the patient 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 32 mg per day; wherein the amount of the bupropion or pharmaceutically acceptable salt thereof is about 360 mg per day; and wherein each of the naltrexone or pharmaceutically acceptable salt thereof and bupropion or pharmaceutically acceptable salt thereof is in a sustained release formulation.

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