Details for Patent: 9,770,455

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)
Filing Date:	Jan 05, 2017
Application Number:	15/398,997
Claims:	1. A method for weight management, comprising: administering to an individual having moderate renal impairment and in need of said weight management a therapeutically effective amount of (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine hydrochloride or a hydrated form thereof, wherein said moderate renal impairment is a creatinine clearance from 31 mL/min to 50 mL/min in said individual determined by the Cockcroft-Gault equation using ideal body weight. 2. The method of claim 1, wherein the therapeutically effective amount is about 10 mg of (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine hydrochloride or a hydrated form thereof administered orally twice daily. 3. The method of claim 1, wherein the therapeutically effective amount is about 20 mg administered orally once daily. 4. A method for weight management, comprising: administering to an individual having moderate renal impairment and in need of said weight management a dose of about 20 mg of (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine hydrochloride or a hydrated form thereof, wherein said moderate renal impairment is a creatinine clearance from 31 mL/min to 50 mL/min in said individual determined by the Cockcroft-Gault equation using ideal body weight. 5. The method of claim 4, wherein the dose is administered as about 10 mg of (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine hydrochloride or a hydrated form thereof orally twice daily. 6. The method of claim 4, wherein the dose is administered orally once daily.