Pharmaceutical compositions for combination therapy

Abstract

This invention relates to the use of pharmaceutical compositions comprising a therapeutically effective combination of Tesofensine and Metoprolol for preventing the cardiovascular side effects of Tesofensine, while leaving the robust inhibitory efficacy on food intake and body weight loss unaffected.

1 . A method of inducing hypophagia in a human comprising:
 administering Tesofensine, or a pharmaceutically acceptable salt thereof, to the human;   in combination with Metoprolol, or a pharmaceutically acceptable salt thereof,   wherein the combination is effective in inducing hypophagia and wherein the combination is effective in preventing or alleviating drug-induced cardiovascular side-effects.   
     
     
         2 . The method of  claim 1 , wherein the Tesofensine, or pharmaceutically acceptable salt thereof, is administered at dosage of 0.1 mg to 1 mg daily, based on the amount of free base. 
     
     
         3 . The method of  claim 1 , wherein the Tesofensine, or pharmaceutically acceptable salt thereof, is administered at dosage of 0.1 mg to about 0.5 mg daily, based on the about of free base. 
     
     
         4 . The method of  claim 1 , wherein the Metoprolol, or pharmaceutically acceptable salt thereof, is administered at dosage of 0.25 mg to 200 mg daily, based on the amount of free base. 
     
     
         5 . The method of  claim 1 , wherein the Metoprolol, or pharmaceutically acceptable salt thereof, is administered at dosage of 25 mg to 100 mg daily, based on the amount of free base. 
     
     
         6 . The method of  claim 1 , wherein the human is a pre-obese human, an obese human, or a morbidly obese human. 
     
     
         7 . The method of  claim 1 , wherein the human suffers from over-eating disorders, bulimia nervosa, binge eating disorder, compulsive over-eating, impaired appetite regulation, metabolic syndrome, type 2 diabetes, dyslipidemia, atherosclerosis, or drug-induced obesity. 
     
     
         8 . The method of  claim 1 , wherein the human suffers from an over-eating disorder, bulimia nervosa, binge eating disorder, or compulsive over-eating. 
     
     
         9 . The method of  claim 1 , wherein the drug-induced cardiovascular side effects are increased heart rate, increased diastolic blood pressure, or increased systolic blood pressure, or a combination thereof. 
     
     
         10 . The method of  claim 1 , wherein the Tesofensine or the pharmaceutically acceptable salt thereof and the Metoprolol or the pharmaceutically acceptable salt thereof are administered separately. 
     
     
         11 . The method of  claim 1 , wherein the Tesofensine or the pharmaceutically acceptable salt thereof and the Metoprolol or the pharmaceutically acceptable salt thereof are administered in a combined form. 
     
     
         12 . The method of  claim 1 , wherein the Tesofensine or the pharmaceutically acceptable salt thereof is administered once daily. 
     
     
         13 . The method of  claim 1 , wherein the Metoprolol or the pharmaceutically acceptable salt thereof is administered once daily. 
     
     
         14 . The method of  claim 1 , wherein the Tesofensin or the pharmaceutically acceptable salt thereof and the Metoprolol or the pharmaceutically acceptable salt thereof are administered orally. 
     
     
         15 . The method of  claim 14 , wherein the Tesofensin or the pharmaceutically acceptable salt thereof and the Metoprolol or the pharmaceutically acceptable salt thereof are each administered as a tablet or capsule. 
     
     
         16 . The method of  claim 1 , wherein the human is administered a pharmaceutically acceptable salt of Tesofensine and the pharmaceutically acceptable salt of Tesofensine is Tesofensine citrate. 
     
     
         17 . The method of  claim 1 , wherein the human is administered a pharmaceutically acceptable salt of Metoprolol and the pharmaceutically acceptable salt of Metoprolol is metoprolol succinate.