Method of Treating a Psychotic Disorder

Abstract

Methods and compositions for treating humans suffering from, or preventing a human from suffering, a physiological or psychiatric disease, disorder, or a condition where inhibiting reuptake of norepinephrine is a benefit are disclosed. The compositions comprise a compound having a pharmacological selectivity of serotonin (K i )/norepinephrine (K i ) of at least about 5000. Examples of such compounds include reboxetine, and more preferably optically pure (S,S) enantiomer of reboxetine. The methods generally include administration of a therapeutic amount of such compositions. Also disclosed are preparations of a medicament from the composition, and uses of the composition in a manufacture of the medicament to treat a human suffering from, or preventing a human from suffering, a physiological or psychiatric disease, disorder, or condition.

1 . A method of treating an individual suffering from a psychotic disorder, the method comprising the step of administering to the individual a therapeutically effective amount of optically pure (S,S) reboxetine, or a pharmaceutically acceptable salt thereof.  
     
     
         2 . The method of  claim 1  wherein said optically pure (S,S) reboxetine, or a pharmaceutically acceptable salt thereof, is administered in an amount of about 0.1 to about 10 mg/day.  
     
     
         3 . The method of  claim 2  wherein said optically pure (S,S) reboxetine, or a pharmaceutically acceptable salt thereof, is administered in an amount of about 0.5 to about 8 mg/day.  
     
     
         4 . The method of  claim 3  wherein said optically pure (S,S) reboxetine, or a pharmaceutically acceptable salt thereof, is administered in an amount of about 0.5 to about 5 mg/day.  
     
     
         5 . The method of  claim 4  wherein said optically pure (S,S) reboxetine, or a pharmaceutically acceptable salt thereof, is administered in an amount of about 0.5 to about 2.5 mg/day.  
     
     
         6 . The method of  claim 5  wherein said optically pure (S,S) reboxetine, or a pharmaceutically acceptable salt thereof, is administered in an amount of about 0.5 to about 0.9 mg/day.  
     
     
         7 . The method of  claim 6  wherein said optically pure (S,S) reboxetine, or a pharmaceutically acceptable salt thereof, is administered in an amount of about 0.5 to about 0.8 mg/day.  
     
     
         8 . The method of  claim 7  wherein said optically pure (S,S) reboxetine, or a pharmaceutically acceptable salt thereof, is administered in an amount of about 0.5 to about 0.75 mg/day.  
     
     
         9 . The method of  claim 1  wherein said optically pure (S,S) reboxetine, or a pharmaceutically acceptable salt thereof, is administered as a composition and said composition is administered orally, topically, parenterally, transdermally, rectally, or vaginally.  
     
     
         10 . The method of  claim 9  wherein said composition is orally administered, and further comprising a pharmaceutically acceptable carrier selected from the group consisting of a binder, diluent, lubricant, disintegrating agent, effervescing agent, dyestuff, sweetener, wetting agent, and mixtures thereof.  
     
     
         11 . The method of  claim 10  wherein the oral administration is by a sachet, capsule, tablet, or aerosol spray.  
     
     
         12 . The method of  claim 9  wherein said composition is parenterally administered subcutaneously, intravenously, or intramuscularly.  
     
     
         13 . (canceled)  
     
     
         14 . The method of  claim 1  wherein the pharmaceutically acceptable salt is a methanesulfonate salt.  
     
     
         15 . The method of  claim 1  wherein the optically pure (S,S) reboxetine or pharmaceutically acceptable salt thereof comprises at least about 90 wt. % of (S,S) reboxetine, and less than about 10 wt. % of (R,R) reboxetine, based on the total weight of reboxetine present.  
     
     
         16 . The method of  claim 15  wherein the optically pure (S,S) reboxetine or pharmaceutically acceptable salt thereof comprises at least about 97 wt. % of (S,S) reboxetine and less than about 3 wt. % of (R,R) reboxetine, based on the total weight of reboxetine present.  
     
     
         17 . The method of  claim 16  wherein the optically pure (S,S) reboxetine or pharmaceutically acceptable salt thereof comprises at least about 99 wt. % of (S,S) reboxetine and less than about 1 wt. % of (R,R) reboxetine, based on the total weight of reboxetine present.  
     
     
         18 - 23 . (canceled)  
     
     
         24 . The method of  claim 1  wherein the psychotic disorder is selected from the group consisting of schizophrenia, a schizoaffective disorder, a schizophreniform disorder, and combinations thereof.  
     
     
         25 - 38 . (canceled)  
     
     
         39 . A method of treating an individual suffering from a psychotic disorder, while diminishing adverse side effects, the method comprising the step of administering to the individual a total dose of about 0.1 to about 10 mg/day of an optically pure (S,S) reboxetine, or a pharmaceutically acceptable salt thereof.  
     
     
         40 . The method of  claim 39  wherein said adverse side effects comprise dizziness, insomnia, lightheadedness, changes in blood pressure, sweating, gastrointestinal disturbances, sexual dysfunction in males, anticholinergic-like effects, or side effects with drug-drug interactions.  
     
     
         41 . A method of treating an individual suffering from a psychotic disorder, the method comprising the step of administering to the individual a therapeutically effective amount of racemic reboxetine or a pharmaceutically acceptable salt thereof.  
     
     
         42 . (canceled)  
     
     
         43 . (canceled)  
     
     
         44 . The method of  claim 41  wherein said racemic reboxetine, or a pharmaceutically acceptable salt thereof, is administered to the individual in an amount of about 2 to about 20 mg/day.  
     
     
         45 . The method of  claim 44  wherein said racemic reboxetine, or a pharmaceutically acceptable salt thereof, is administered to the individual in an amount of about 4 to about 10 mg/day.  
     
     
         46 . The method of  claim 45  wherein said racemic reboxetine, or a pharmaceutically acceptable salt thereof, is administered to the individual in an amount of about 6 to about 10 mg/day.  
     
     
         47 . The method of  claim 41  wherein said racemic reboxetine, or a pharmaceutically acceptable salt thereof, is administered as a composition and said composition is administered orally, parenterally, topically, transdermally, rectally, or vaginally.  
     
     
         48 . The method of  claim 47  wherein said composition is orally administered, and further comprising with a pharmaceutically acceptable carrier comprising at least one of a binder, diluent, lubricant, disintegrating agent, effervescing agent, dyestuff, sweetener, and wetting agent.  
     
     
         49 . The method of  claim 48  wherein the oral administration is by a sachet, capsule, tablet, or aerosol spray.  
     
     
         50 . The method of  claim 47  wherein said composition is parenterally administered subcutaneously, intravenously, or intramuscularly.  
     
     
         51 . The method of  claim 41  wherein the pharmaceutically acceptable salt is methanesulfonate salt.  
     
     
         52 . (canceled)  
     
     
         53 . (canceled)  
     
     
         54 . The method of  claim 39 , wherein said optically pure (S,S) reboxetine, or a pharmaceutically acceptable salt thereof, is administered in an amount of about 0.5 to about 8 mg/day.  
     
     
         55 . The method of  claim 54 , wherein said optically pure (S,S) reboxetine, or a pharmaceutically acceptable salt thereof, is administered in an amount of about 0.5 to about 5 mg/day.  
     
     
         56 . The method of  claim 55 , wherein said optically pure (S,S) reboxetine, or a pharmaceutically acceptable salt thereof, is administered in an amount of about 0.5 to about 2.5 mg/day.  
     
     
         57 . The method of  claim 56 , wherein said optically pure (S,S) reboxetine, or a pharmaceutically acceptable salt thereof, is administered in an amount of about 0.5 to about 0.9 mg/day.  
     
     
         58 . The method of  claim 57 , wherein said optically pure (S,S) reboxetine, or a pharmaceutically acceptable salt thereof, is administered in an amount of about 0.5 to about 0.8 mg/day.  
     
     
         59 . The method of  claim 58 , wherein said optically pure (S,S) reboxetine, or a pharmaceutically acceptable salt thereof, is administered in an amount of about 0.5 to about 0.75 mg/day.  
     
     
         60 . The method of  claim 39 , wherein said optically pure (S,S) reboxetine, or a pharmaceutically acceptable salt thereof, is administered as a composition and said composition is administered orally, topically, parenterally, transdermally, rectally, or vaginally.  
     
     
         61 . The method of  claim 60 , wherein said composition is orally administered, and further comprising a pharmaceutically acceptable carrier selected from the group consisting of a binder, diluent, lubricant, disintegrating agent, effervescing agent, dyestuff, sweetener, wetting agent, and mixtures thereof.  
     
     
         62 . The method of  claim 61 , wherein the oral administration is by a sachet, capsule, tablet, or aerosol spray.  
     
     
         63 . The method of  claim 60 , wherein said composition is parenterally administered subcutaneously, intravenously, or intramuscularly.  
     
     
         64 . The method of  claim 39 , wherein the pharmaceutically acceptable salt is a methanesulfonate salt.  
     
     
         65 . The method of  claim 39 , wherein the optically pure (S,S) reboxetine or pharmaceutically acceptable salt thereof comprises at least about 90 wt. % of (S,S) reboxetine, and less than about 10 wt. % of (R,R) reboxetine, based on the total weight of reboxetine present.  
     
     
         66 . The method of  claim 65 , wherein the optically pure (S,S) reboxetine or pharmaceutically acceptable salt thereof comprises at least about 97 wt. % of (S,S) reboxetine and less than about 3 wt. % of (R,R) reboxetine, based on the total weight of reboxetine present.  
     
     
         67 . The method of  claim 66 , wherein the optically pure (S,S) reboxetine or pharmaceutically acceptable salt thereof comprises at least about 99 wt. % of (S,S) reboxetine and less than about 1 wt. % of (R,R) reboxetine, based on the total weight of reboxetine present.  
     
     
         68 . The method of  claim 39 , wherein the psychotic disorder is selected from the group consisting of schizophrenia, a schizoaffective disorder, a schizophreniform disorder, and combinations thereof.  
     
     
         69 . The method of  claim 41 , wherein the psychotic disorder is selected from the group consisting of schizophrenia, a schizoaffective disorder, a schizophreniform disorder, and combinations thereof.