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Claims for Patent: 8,999,970

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Claims for Patent: 8,999,970

Title:Administration of an anti-obesity compound to individuals with renal impairment
Abstract: The present disclosure relates to methods for weight management in an individual in need thereof by determining the level of renal sufficiency of the individual and prescribing or administering a therapeutically effective amount of (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine or a pharmaceutically acceptable salt, solvate or hydrate thereof to the individual, provided that the individual has a level of renal sufficiency selected from the group consisting of: no renal impairment, mild renal impairment, and moderate renal impairment. In addition, the disclosure relates to a method for selecting an individual for treatment with (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine or a pharmaceutically acceptable salt, solvate or hydrate thereof from a plurality of individuals in need of weight management by determining the level of renal sufficiency of the individual and selecting the individual for treatment with (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine or a pharmaceutically acceptable salt, solvate or hydrate thereof if the individual has a level of renal sufficiency selected from the group consisting of: no renal impairment, mild renal impairment, and moderate renal impairment.
Inventor(s): Anderson; Christen M. (Encinitas, CA), Shanahan; William R. (Del Mar, CA)
Assignee: Arena Pharmaceuticals, Inc. (San Diego, CA)
Application Number:13/511,639
Patent Claims: 1. A method for weight management, for decreasing food intake, for inducing satiety, and/or for treating obesity in an individual in need thereof, comprising: administering a therapeutically effective amount of (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine or a pharmaceutically acceptable salt, solvate or hydrate thereof to the individual, provided that the individual does not have severe renal impairment or end stage renal disease.

2. The method of claim 1, further comprising administering a reduced-calorie diet to the individual.

3. The method of claim 1, further comprising administering a program of regular exercise to the individual.

4. The method of claim 1, further comprising administering phentermine to the individual.

5. The method of claim 1, wherein the Cockcroft-Gault equation is used to determine the level of renal sufficiency of the individual.

6. The method of claim 5, wherein the individual has a creatinine clearance rate of greater than about 30 mL/minute using the Cockcroft-Gault equation.

7. The method of claim 1, wherein the individual's serum creatinine concentration is used to determine the level of renal sufficiency of the individual.

8. The method of claim 7, wherein the individual has an approximate serum creatinine concentration of: (i) less than 4.9 mg/dL for an 18-20 year old man, (ii) less than 3.5 mg/dL for an 18-20 year old woman, (iii) less than 4.5 mg/dL for a 21-30 year old man, (iv) less than 3.2 mg/dL for a 21-30 year old woman, (v) less than 4.1 mg/dL for a 31-40 year old man, (vi) less than 2.9 mg/dL for a 31-40 year old woman, (viii) less than 2.7 mg/dL for a 41-50 year old woman, (ix) less than 3.3 mg/dL for a 51-60 year old man, (x) less than 2.4 mg/dL for a 51-60 year old woman, (xi) less than 3.0 mg/dL for a man over 60 years old, or (xii) less than 2.0 mg/dL for a woman over 60 years old.

9. The method of claim 1, wherein the individual has mild renal impairment.

10. The method of claim 1, wherein the individual has moderate renal impairment.

11. The method of claim 1, wherein said administering results in a reduction in the risk of an adverse event.

12. The method of claim 1, wherein weight management comprises weight loss.

13. The method of claim 1, wherein weight management comprises maintenance of weight loss.

14. The method of claim 1, wherein the individual is an individual with an initial body mass index .gtoreq.25 kg/m.sup.2.

15. The method of claim 14, wherein the individual has at least one weight related comorbid condition.

16. The method of claim 15, wherein the weight related comorbid condition is selected from the group consisting of: hypertension, dyslipidemia, cardiovascular disease, glucose intolerance and sleep apnea.

17. The method of claim 1, wherein the individual is an individual with an initial body mass index .gtoreq.27 kg/m.sup.2.

18. The method of claim 17, wherein the individual has at least one weight related comorbid condition.

19. The method of claim 18, wherein the weight related comorbid condition is selected from the group consisting of: hypertension, dyslipidemia, cardiovascular disease, glucose intolerance and sleep apnea.

20. The method of claim 1, wherein the individual is an individual with an initial body mass index .gtoreq.30 kg/m.sup.2.

21. The method of claim 1, wherein the compound is selected from: (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine hydrochloride and pharmaceutically acceptable solvates and hydrates thereof.

22. The method of claim 1, wherein the compound is (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine hydrochloride salt hemihydrate.

23. A method for weight management, for decreasing food intake, for inducing satiety, and/or for treating obesity in an individual in need thereof, comprising: administering a therapeutically effective amount of (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine or a pharmaceutically acceptable salt, solvate or hydrate thereof to the individual, provided that the individual is selected from the group of individuals having no renal impairment, mild renal impairment, and moderate renal impairment.

24. A method for weight management, for decreasing food intake, for inducing satiety, and/or for treating obesity in an individual in need thereof, comprising: administering a therapeutically effective amount of (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine or a pharmaceutically acceptable salt, solvate or hydrate thereof to the individual, provided that the individual has mild renal impairment or moderate renal impairment.

25. A method for weight management, for decreasing food intake, for inducing satiety, and/or for treating obesity in an individual in need thereof, comprising: determining the renal sufficiency level of the individual, and administering a therapeutically effective amount of (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine or a pharmaceutically acceptable salt, solvate or hydrate thereof to the individual, provided that the individual does not have severe renal impairment or end stage renal disease.

26. A method for weight management, for decreasing food intake, for inducing satiety, and/or for treating obesity in an individual in need thereof, comprising: determining the renal sufficiency level of the individual, and administering a therapeutically effective amount of (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine or a pharmaceutically acceptable salt, solvate or hydrate thereof to the individual, provided that the individual is selected from the group of individuals having no renal impairment, mild renal impairment, and moderate renal impairment.

27. A method for weight management, for decreasing food intake, for inducing satiety, and/or for treating obesity in an individual in need thereof, comprising: determining the renal sufficiency level of the individual, and administering a therapeutically effective amount of (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine or a pharmaceutically acceptable salt, solvate or hydrate thereof to the individual, provided that the individual has mild renal impairment or moderate renal impairment.

28. A method for selecting an individual for treatment with (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine or a pharmaceutically acceptable salt, solvate or hydrate thereof, comprising determining the renal sufficiency level of the individual in need of treatment with (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine or a pharmaceutically acceptable salt, solvate or hydrate thereof, selecting an individual with a creatinine clearance rate of greater than about 30 mL/minute, and administering a therapeutically effective amount of (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine or a pharmaceutically acceptable salt, solvate or hydrate thereof to the individual.
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