Co-therapy comprising canagliflozin and phentermine for the treatment of obesity and obesity related disorders

Abstract

The present invention is directed to the use of co-therapy comprising administration of canagliflozin and phentermine for the treatment of obesity and obesity related disorders. More particularly, the present invention is directed to co-therapy for treating obesity, for promoting weight loss and/or for suppressing appetite; for treating, delaying, slowing the progression of and/or preventing metabolic disorders (including for example Type 2 diabetes mellitus); for treating, delaying, slowing the progression of and/or preventing renal or fatty liver disorders (including for example NASH, NAFLD, etc.); for treating, delaying, slowing the progression of and/or preventing sleep disorders (including for example sleep apnea); for providing cardiovascular protection; for treating, delaying, slowing the progression of and/or preventing cardiovascular events (including major adverse cardiac events (MACE) such as myocardial infarction, unstable angina, cardiovascular death, revascularization, fatal or non-fatal cerebrovascular accident, peripheral arteriopathy, aortic events, hospitalization due to congestive heart failure, etc.); and/or for extending or prolonging life span.

1 - 9 . (canceled) 
     
     
         10 . The method of  claim 50 , wherein the subject in need thereof is overweight or obese. 
     
     
         11 - 14 . (canceled) 
     
     
         15 . The method of  claim 50 , wherein the subject in need thereof is overweight or obese; and wherein the subject in need thereof has been diagnosed with or exhibits one or more symptoms of a disorder selected from the group consisting of pre-diabetes, impaired oral glucose tolerance, Type II diabetes mellitus, Metabolic Syndrome, cardiovascular risk, renal or fatty liver disorder and sleep apnea. 
     
     
         16 . The method of  claim 50 , wherein the subject in need thereof has been diagnosed with or shows one or more symptoms of one or more of the following conditions: (a) diabetes mellitus, regardless of type; (b) chronic kidney disease (CKD); (c) acute renal failure (ARF); (d) renal transplant recipients; (e) renal transplant donors; (f) unilateral total or partial nephrectomized patients; or (g) nephrotic syndrome. 
     
     
         17 . (canceled) 
     
     
         18 . The method of  claim 50 , wherein the subject in need thereof is diabetic or pre-diabetic. 
     
     
         19 . The method of  claim 50 , wherein the subject in need thereof is non-diabetic. 
     
     
         20 - 33 . (canceled) 
     
     
         34 . The method of  claim 50 , wherein the canagliflozin is administered as a crystalline hemihydrate. 
     
     
         35 . The method of  claim 50 , wherein the canagliflozin is administered in an amount in the range of from about 100 to about 300 mg. 
     
     
         36 . The method of  claim 50 , wherein the canagliflozin is administered in an amount of about 100 mg or about 300 mg. 
     
     
         37 . The method of  claim 50 , wherein the phentermine is phentermine hydrochloride. 
     
     
         38 . The method of  claim 50 , wherein the phentermine is administered in an amount in the range of from about 3.75 mg to about 37.5 mg. 
     
     
         39 . The method of  claim 50 , wherein the phentermine is administered in an amount of about 3.75 mg, about 7.5 mg, about 15 mg, about 30 mg or about 37.5 mg. 
     
     
         40 . The method of  claim 50 , wherein the phentermine is administered in an amount of about 3.75 mg, about 7.5 mg or about 15 mg. 
     
     
         41 - 44 . (canceled) 
     
     
         45 . A pharmaceutical composition comprising
 (a) canagliflozin in an amount in the range of from about 50 mg to about 500 mg per day;   (b) phentermine in an amount in the range of from about 3.75 mg to about 50 mg per day; and   (c) a pharmaceutically acceptable carrier or excipient.   
     
     
         46 - 49 . (canceled) 
     
     
         50 . A method for chronic weight management comprising administering to a subject in need thereof a therapeutically effective amount of co-therapy comprising (a) canagliflozin and (b) phentermine;
 wherein the subject in need thereof is a subject with an initial body mass index greater than or equal to about 30 kg/m 2 ; or greater than or equal to about 27 kg/m 2  and diagnosed with or exhibiting at least one weight-related co-morbid condition.   
     
     
         51 . The method of  claim 50 , wherein the co-therapy is an adjunct to a reduced-calorie diet and increased physical activity.