Claims for Patent: 9,169,213

Summary for Patent: 9,169,213

Title:	Method of weight management
Abstract:	Provided are methods of determining if an individual is a responder to treatment with (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine or a pharmaceutically acceptable salt, solvate or hydrate thereof. Also provided are methods 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. Also provided are methods for weight management in an individual in need thereof. Also provided are compounds, compositions, and kits for use in a method of weight management in an individual.
Inventor(s):	Sanchez; Matilde (Alexandria, VA), Shanahan; William R. (Del Mar, CA)
Assignee:	Arena Pharmaceuticals, Inc. (San Diego, CA)
Application Number:	14/242,442
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,169,213
Patent Claims:	1. A method of weight management for an individual in need thereof comprising: treating the individual for 12 weeks with (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine or a pharmaceutically acceptable salt, solvate or hydrate thereof wherein the individual is administered a dose equivalent to 20 mg of (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1 H-3-benzazepine hydrochloride per day, and continuing said treatment if the individual has achieved at least 5% weight loss by week 12, whereby achievement of at least 5% weight loss by week 12 correlates with a likelihood of the individual achieving an additional decrease in an assessment of weight after about one year, wherein the method further comprises administering a reduced-calorie diet to the individual, wherein, prior to beginning the treatment, the individual has an initial body mass index (BMI) of >27 kg/m.sup.2, and wherein the pharmaceutical composition is administered orally to the individual. 2. The method of claim 1, wherein the individual has an initial BMI >30kg/m.sup.2. 3. The method of claim 1, wherein the individual has at least one weight-related comorbid condition. 4. The method of claim 3, wherein the weight-related comorbid condition is selected from: hypertension, dyslipidemia, and type 2 diabetes. 5. The method of claim 1, wherein weight management comprises weight loss. 6. The method of claim 1, wherein weight management comprises controlling weight gain. 7. The method of claim 1, wherein weight management comprises maintenance of weight loss. 8. The method of claim 1, wherein the method further comprises prescribing and/or administering a program of regular exercise to the individual. 9. A method of decreasing food intake in an individual in need thereof comprising: treating the individual for 12 weeks with (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine or a pharmaceutically acceptable salt, solvate or hydrate thereof, wherein the individual is administered a dose equivalent to 20 mg of (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1 H-3-benzazepine hydrochloride per day, and continuing said treatment if the individual has achieved at least 5% weight loss by week 12, whereby achievement of at least 5% weight loss by week 12 correlates with a likelihood of the individual achieving an additional decrease in an assessment of weight after about one year, wherein the method further comprises administering a reduced-calorie diet to the individual, wherein, prior to beginning the treatment, the individual has an initial body mass index (BMI)of >27 kg/m.sup.2, and wherein the pharmaceutical composition is administered orally to the individual. 10. The method of claim 9, wherein the individual has an initial BMI >30kg/m.sup.2. 11. The method of claim 9, wherein the individual has at least one weight-related comorbid condition. 12. The method of claim 11, wherein the weight-related comorbid condition is selected from: hypertension, dyslipidemia, and type 2 diabetes. 13. The method of claim 9, wherein the method further comprises prescribing and/or administering a program of regular exercise to the individual. 14. A method of inducing satiety in an individual in need thereof comprising: treating the individual for 12 weeks with (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine or a pharmaceutically acceptable salt, solvate or hydrate thereof, wherein the individual is administered a dose equivalent to 20 mg of (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1 H-3-benzazepine hydrochloride per day, and continuing said treatment if the individual has achieved at least 5% weight loss by week 12,whereby achievement of at least 5% weight loss by week 12 correlates with a likelihood of the individual achieving an additional decrease in an assessment of weight after about one year, wherein the method further comprises administering a reduced-calorie diet to the individual, wherein, prior to beginning the treatment, the individual has an initial body mass index (BMI)of >27 kg/m.sup.2, and wherein the pharmaceutical composition is administered orally to the individual. 15. The method of claim 14, wherein the individual has an initial BMI >30kg/m.sup.2. 16. The method of claim 14, wherein the individual has at least one weight-related comorbid condition. 17. The method of claim 16, wherein the weight-related comorbid condition is selected from: hypertension, dyslipidemia, and type 2 diabetes. 18. The method of claim 14, wherein the method further comprises prescribing and/or administering a program of regular exercise to the individual. 19. A method of treating obesity in an individual in need thereof comprising: treating the individual for 12 weeks with (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine or a pharmaceutically acceptable salt, solvate or hydrate thereof, wherein the individual is administered a dose equivalent to 20 mg of (R)-8-chloro-1methyl-2,3,4,5-tetrahydro-1 H-3-benzazepine hydrochloride per day, and continuing said treatment if the individual has achieved at least 5% weight loss by week 12, whereby achievement of at least 5% weight loss by week 12 correlates with a likelihood of the individual achieving an additional decrease in an assessment of weight after about one year, wherein the method further comprises administering a reduced-calorie diet to the individual, wherein, prior to beginning the treatment, the individual has an initial body mass index (BMI)of >30 kg/m.sup.2, and wherein the pharmaceutical composition is administered orally to the individual. 20. The method of claim 19, wherein the individual has at least one weight-related comorbid condition. 21. The method of claim 20, wherein the weight-related comorbid condition is selected from: hypertension, dyslipidemia, and type 2 diabetes. 22. The method of claim 19, wherein the method further comprises prescribing and/or administering a program of regular exercise to the individual.