US2015313884A1PendingUtilityA1

Use of alpha 7 nicotinic acetylcholine receptor agonists

Assignee: NOVARTIS AGPriority: Jan 15, 2013Filed: Jul 15, 2015Published: Nov 5, 2015
Est. expiryJan 15, 2033(~6.5 yrs left)· nominal 20-yr term from priority
A61K 31/444A61K 31/135A61K 45/06A61K 47/02A61K 9/0019A61K 31/08
50
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Claims

Abstract

The invention concerns the use of certain alpha 7 nicotinic acetylcholine receptor agonist for the facilitation of emergence from general anesthesia.

Claims

exact text as granted — not AI-modified
1 . An alpha 7 nicotinic acetylcholine receptor agonist for use in the facilitation of emergence from general anesthesia;
 wherein said alpha 7 nicotinic acetylcholine receptor agonist is   (i) a compound of formula (I)   
       
         
           
           
               
               
           
         
         wherein 
         L 1  is —CH 2 —; L 2  is —CH 2 —CH 2 —; and L 3  is —CH 2 — or —CH(CH 3 )—; or 
         L 1  is —CH 2 —CH 2 —; L 2  is —CH 2 —; and L 3  is —CH 2 —CH 2 —; 
         L 4  is a group selected from 
       
       
         
           
           
               
               
           
         
         wherein the bond marked with the asterisk is attached to the azabicycloalkyl moiety; 
         R 1  is methyl; 
         X 1  is —O— or —NH—; 
         A 2  is selected from 
       
       
         
           
           
               
               
           
         
         wherein the bond marked with the asterisk is attached to X 1 ; 
         A 1  is phenyl, indole or 1,3-dihydro-indol-2-one, which may be substituted once or more than once by R 2 , each R 2  independently is C 1-6  alkyl, C 1-6  halogenalkyl or halogen; or 
         (ii) a compound selected from the group consisting of 
         4-(5-phenyl-1,3,4-thiadiazol-2-yloxy)-1azatricyclo[3.3.1.1 3,7 ]decane; 
         (4S)-4-(5-phenyl-1,3,4-thiadiazol-2-yloxy)-1azatricyclo[3.3.1.1 3,7 ]decane; 
         4-(6-(1H-indol-5-yl)-pyridazin-3-yloxy)-1azatricyclo[3.3.1.1 3,7 ]decane; 
         4-(6-(1H-indol-5-yl)-pyridin-3-yloxy)-1 azatricyclo[3.3.1.1 3,7 ]decane; 
         4-(5-(1H-indol-5-yl)-pyrimidin-2-yloxy)-1azatricyclo[3.3.1.1 3,7 ]decane; 
         N-(1-azabicyclo[2.2.2]oct-3-yl)-1H-indazole-3-carboxamide; 
         N-((3R)-1-azabicyclo[2.2.2]oct-3-yl)-1H-indazole-3-carboxamide 
         N-((3S)-1-azabicyclo[2.2.2]oct-3-yl)-1H-indazole-3-carboxamide 
         N-(1-azabicyclo[2.2.2]oct-3-yl)-5-(trifluoromethoxy)-1H-indazole-3-carboxamide; 
         N-((3R)-1-azabicyclo[2.2.2]oct-3-yl)-5-(trifluoromethoxy)-1H-indazole-3-carboxamide; 
         N-((3S)-1-azabicyclo[2.2.2]oct-3-yl)-5-(trifluoromethoxy)-1H-indazole-3-carboxamide; 
         N-(2-((3-pyridinyl)methyl)-1-azabicyclo[2.2.2]oct-3-yl)benzofuran-2-carboxamide; 
         (2S,3R)—N-(2-((3-pyridinyl)methyl)-1-azabicyclo[2.2.2]oct-3-yl)benzofuran-2-carboxamide; 
         N-(2-((3-pyridinyl)methyl)-1-azabicyclo[2.2.2]oct-3-yl)-3,5-difluorobenzamide; 
         (2S,3R)—N-(2-((3-pyridinyl)methyl)-1-azabicyclo[2.2.2]oct-3-yl)-3,5-difluorobenzamide; 
         N-(2-((3-pyridinyl)methyl)-1-azabicyclo[2.2.2]oct-3-yl)-5-methylthiophene-2-carboxamide; 
         (2S,3R)—N-(2-((3-pyridinyl)methyl)-1-azabicyclo[2.2.2]oct-3-yl)-5-methylthiophene-2-carboxamide; 
         N-(2-((3-pyridinyl)methyl)-1-azabicyclo[2.2.2]oct-3-yl)-5-(2-pyridinyl)thiophene-2-carboxamide; 
         (2S,3R)—N-(2-((3-pyridinyl)methyl)-1-azabicyclo[2.2.2]oct-3-yl)-5-(2-pyridinyl)thiophene-2-carboxamide; 
         7,8,9,10-tetrahydro-6,10-methano-6H-pyrazino-(2,3-h)(3)-benzazepine; 
         3-[1-(2,4-Dimethoxy-phenyl)-meth-(E)-ylidene]-3,4,5,6-tetrahydro-[2,3]bipyridinyl; 
         N-methyl-1-{5-[3′H-spiro[4-azabicyclo[2.2.2]octane-2,2′-furo[2,3-b]pyridin]-5′-yl]-2-thienyl}methanamine; 
         N-methyl-1-{5-[(2R)-3′H-spiro[4-azabicyclo[2.2.2]octane-2,2′-furo[2,3-b]pyridin]-5′-yl]-2-thienyl}methanamine; 
         N-methyl-1-{5-[(2S)-3′H-spiro[4-azabicyclo[2.2.2]octane-2,2′-furo[2,3-b]pyridin]-5′-yl]-2-thienyl}methanamine; 
         (R)-7-chloro-N-(quinuclidin-3-yl)benzo[b]thiophene-2-carboxamide; 
         5-{5-[(endo)-8-azabicyclo[3.2.1]octan-3-yloxy]pyridin-2-yl}-1H-indole; 
         5-{5-[(exo)-8-azabicyclo[3.2.1]octan-3-yloxy]pyridin-2-yl}-1H-indole; 
         5-{5-[(endo)-8-methyl-8-aza-bicyclo[3.2.1]oct-3-yloxy]pyridin-2-yl}-1H-indole; 
         5-{5-[(exo)-8-methyl-8-aza-bicyclo[3.2.1]oct-3-yloxy]pyridin-2-yl}-1H-indole; 
         4-{5-[(exo)-8-methyl-8-aza-bicyclo[3.2.1]oct-3-yloxy]pyridin-2-yl}-1H-indole; 
         5-{6-[(exo)-8-methyl-8-aza-bicyclo[3.2.1]oct-3-yloxy]pyridin-3-yl}-1H-indole; 
         (2′R)-spiro-[1-azabicyclo[2.2.2]octane-3,2′(3′H)-furo[2,3-b]pyridine]; 
         1,4-Diaza-bicyclo[3.2.2]nonane-4-carboxylic acid 4-bromo-phenyl ester; and 
         5-{6-[1-azabicyclo[2.2.2]oct-3-yloxy]pyridazin-3-yl}-1H-indole; 
         in free base form or in acid addition salt form. 
       
     
     
         2 . An alpha 7 nicotinic acetylcholine receptor agonist according to  claim 1  for use in the facilitation of emergence from general anesthesia in a subject treated with a general anesthetic agent,
 wherein the general anesthetic agent is selected from an intravenous anesthetic and an inhalation anesthetic, or a combination thereof. 
 
     
     
         3 . (canceled) 
     
     
         4 . An alpha 7 nicotinic acetylcholine receptor agonist according to  claim 2 , wherein the general anesthetic agent is selected from propofol; etomidate; a barbiturate; a benzodiazepine; ketamine, a halogenated ether, alone or combined with nitrous oxide; halothane; and xenon; or a combination thereof. 
     
     
         5 . An alpha 7 nicotinic acetylcholine receptor agonist according to  claim 2 , wherein the general anesthetic agent is a combination of ketamine for the induction period and sevoflurane for the maintenance period. 
     
     
         6 . An alpha 7 nicotinic acetylcholine receptor agonist according to  claim 2 , wherein the subject is a perioperative patient. 
     
     
         7 . (canceled) 
     
     
         8 . An alpha 7 nicotinic acetylcholine receptor agonist according to  claim 2 , wherein the agonist is administered by intravenous administration, and wherein the intravenous administration of the agonist occurs when the subject is no longer being treated with the general anesthetic agent. 
     
     
         9 - 10 . (canceled) 
     
     
         11 . An alpha 7 nicotinic acetylcholine receptor agonist according to  claim 8 , wherein the agonist administration is continuous intravenous infusion of 1 to 200 mg of the agonist within 10 to 60 minutes. 
     
     
         12 . An alpha 7 nicotinic acetylcholine receptor agonist according to  claim 1 , wherein the agonist is (R)-3-(6-p-tolyl-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane in free base form or in acid addition salt form. 
     
     
         13 - 14 . (canceled) 
     
     
         15 . A pharmaceutical composition in the form of an aqueous solution for intravenous administration comprising
 an alpha 7 nicotinic acetylcholine receptor agonist as defined in  claim 1 ; and   at least one pharmaceutically acceptable excipient.   
     
     
         16 . An alpha 7 nicotinic acetylcholine receptor agonist for use in the treatment, amelioration, prevention or delay of progression of fatigue;
 wherein said alpha 7 nicotinic acetylcholine receptor agonist is   (i) a compound of formula (I)   
       
         
           
           
               
               
           
         
         wherein 
         L 1  is —CH 2 —; L 2  is —CH 2 —CH 2 —; and L 3  is —CH 2 — or —CH(CH 3 )—; or 
         L 1  is —CH 2 —CH 2 —; L 2  is —CH 2 —; and L 3  is —CH 2 —CH 2 —; 
         L 4  is a group selected from 
       
       
         
           
           
               
               
           
         
         wherein the bond marked with the asterisk is attached to the azabicycloalkyl moiety; 
         R 1  is methyl; 
         X 1  is —O— or —NH—; 
         A 2  is selected from 
       
       
         
           
           
               
               
           
         
         wherein the bond marked with the asterisk is attached to X 1 ; 
         A 1  is phenyl, indole or 1,3-dihydro-indol-2-one, which may be substituted once or more than once by R 2 , each R 2  independently is C 1-6  alkyl, C 1-6  halogenalkyl or halogen; or 
         (ii) a compound selected from the group consisting of 
         4-(5-phenyl-1,3,4-thiadiazol-2-yloxy)-1 azatricyclo[3.3.1.1 3,7 ]decane; 
         (4S)-4-(5-phenyl-1,3,4-thiadiazol-2-yloxy)-1azatricyclo[3.3.1.1 3,7 ]decane; 
         4-(6-(1H-indol-5-yl)-pyridazin-3-yloxy)-1 azatricyclo[3.3.1.1 3,7 ]decane; 
         4-(6-(1H-indol-5-yl)-pyridin-3-yloxy)-1 azatricyclo[3.3.1.1 3,7 ]decane; 
         4-(5-(1H-indol-5-yl)-pyrimidin-2-yloxy)-1 azatricyclo[3.3.1.1 3,7 ]decane; 
         N-(1-azabicyclo[2.2.2]oct-3-yl)-1H-indazole-3-carboxamide; 
         N-((3R)-1-azabicyclo[2.2.2]oct-3-yl)-1H-indazole-3-carboxamide 
         N-((3S)-1-azabicyclo[2.2.2]oct-3-yl)-1H-indazole-3-carboxamide N-(1-azabicyclo[2.2.2]oct-3-yl)-5-(trifluoromethoxy)-1H-indazole-3-carboxamide; 
         N-((3R)-1-azabicyclo[2.2.2]oct-3-yl)-5-(trifluoromethoxy)-1H-indazole-3-carboxamide; 
         N-((3S)-1-azabicyclo[2.2.2]oct-3-yl)-5-(trifluoromethoxy)-1H-indazole-3-carboxamide; 
         N-(2-((3-pyridinyl)methyl)-1-azabicyclo[2.2.2]oct-3-yl)benzofuran-2-carboxamide; 
         (2S,3R)—N-(2-((3-pyridinyl)methyl)-1-azabicyclo[2.2.2]oct-3-yl)benzofuran-2-carboxamide; 
         N-(2-((3-pyridinyl)methyl)-1-azabicyclo[2.2.2]oct-3-yl)-3,5-difluorobenzamide; 
         (2S,3R)—N-(2-((3-pyridinyl)methyl)-1-azabicyclo[2.2.2]oct-3-yl)-3,5-difluorobenzamide; 
         N-(2-((3-pyridinyl)methyl)-1-azabicyclo[2.2.2]oct-3-yl)-5-methylthiophene-2-carboxamide; 
         (2S,3R)—N-(2-((3-pyridinyl)methyl)-1-azabicyclo[2.2.2]oct-3-yl)-5-methylthiophene-2-carboxamide; 
         N-(2-((3-pyridinyl)methyl)-1-azabicyclo[2.2.2]oct-3-yl)-5-(2-pyridinyl)thiophene-2-carboxamide; 
         (2S,3R)—N-(2-((3-pyridinyl)methyl)-1-azabicyclo[2.2.2]oct-3-yl)-5-(2-pyridinyl)thiophene-2-carboxamide; 
         7,8,9,10-tetrahydro-6,10-methano-6H-pyrazino-(2,3-h)(3)-benzazepine; 
         3-[1-(2,4-Dimethoxy-phenyl)-meth-(E)-ylidene]-3,4,5,6-tetrahydro-[2,3′]bipyridinyl; 
         N-methyl-1-{5-[3′H-spiro[4-azabicyclo[2.2.2]octane-2,2′-furo[2,3-b]pyridin]-5′-yl]-2-thienyl}methanamine; 
         N-methyl-1-{5-[(2R)-3′H-spiro[4-azabicyclo[2.2.2]octane-2,2′-furo[2,3-b]pyridin]-5′-yl]-2-thienyl}methanamine; 
         N-methyl-1-{5-[(2S)-3′H-spiro[4-azabicyclo[2.2.2]octane-2,2′-furo[2,3-b]pyridin]-5′-yl]-2-thienyl}methanamine; 
         (R)-7-chloro-N-(quinuclidin-3-yl)benzo[b]thiophene-2-carboxamide; 
         5-{5-[(endo)-8-azabicyclo[3.2.1]octan-3-yloxy]pyridin-2-yl}-1H-indole; 
         5-{5-[(exo)-8-azabicyclo[3.2.1]octan-3-yloxy]pyridin-2-yl}-1H-indole; 
         5-{5-[(endo)-8-methyl-8-aza-bicyclo[3.2.1]oct-3-yloxy]pyridin-2-yl}-1H-indole; 
         5-{5-[(exo)-8-methyl-8-aza-bicyclo[3.2.1]oct-3-yloxy]pyridin-2-yl}-1H-indole; 
         4-{5-[(exo)-8-methyl-8-aza-bicyclo[3.2.1]oct-3-yloxy]pyridin-2-yl}-1H-indole; 
         5-{6-[(exo)-8-methyl-8-aza-bicyclo[3.2.1]oct-3-yloxy]pyridin-3-yl}-1H-indole; 
         (2′R)-spiro-[1-azabicyclo[2.2.2]octane-3,2′(3′H)-furo[2,3-b]pyridine]; 
         1,4-Diaza-bicyclo[3.2.2]nonane-4-carboxylic acid 4-bromo-phenyl ester; and 
         5-{6-[1-azabicyclo[2.2.2]oct-3-yloxy]pyridazin-3-yl}-1H-indole; 
         in free base form or in acid addition salt form. 
       
     
     
         17 . The alpha 7 nicotinic acetylcholine receptor agonist as defined in  claim 16 , wherein the fatigue is fatigue associated with multiple sclerosis, and is (i) caused by sleep deprivation, depression or general disabilities or (ii) lassitude. 
     
     
         18 . (canceled) 
     
     
         19 . The alpha 7 nicotinic acetylcholine receptor agonist as defined in  claim 16 , wherein the fatigue is chronic fatigue syndrome. 
     
     
         20 . The alpha 7 nicotinic acetylcholine receptor agonist as defined in  claim 16 , wherein the fatigue is fatigue associated with an infectious disease, and wherein the fatigue is associate with HIV infection. 
     
     
         21 . (canceled) 
     
     
         22 . The alpha 7 nicotinic acetylcholine receptor agonist as defined in  claim 16 , wherein the daily dosage of said agonist is from 1 to 100 mg. 
     
     
         23 . (canceled) 
     
     
         24 . The alpha 7 nicotinic acetylcholine receptor agonist as defined in  claim 16 , wherein the agonist is (R)-3-(6-p-tolyl-pyridin-3-yloxy)-1-aza-bicyclo[2,2,2]octane in free base form or in acid addition salt form and wherein the daily dosage of said agonist is from 1 to 100 mg. 
     
     
         25 - 27 . (canceled) 
     
     
         28 . A method of treatment amelioration, prevention or delay of progression of fatigue in a subject in need of such treatment, which comprises administering to said subject a therapeutically effective amount of an alpha 7 nicotinic acetylcholine receptor agonist as defined in  claim 16 . 
     
     
         29 - 30 . (canceled) 
     
     
         31 . An alpha 7 nicotinic acetylcholine receptor agonist for use in the treatment, amelioration, prevention or delay of progression of narcolepsy, excessive daytime sleepiness, nocturnal sleep disruption or cataplexy;
 wherein said alpha 7 nicotinic acetylcholine receptor agonist is   (i) a compound of formula (I)   
       
         
           
           
               
               
           
         
         wherein 
         L 1  is —CH 2 —; L 2  is —CH 2 —CH 2 —; and L 3  is —CH 2 — or —CH(CH 3 )—; or 
         L 1  is —CH 2 —CH 2 —; L 2  is —CH 2 —; and L 3  is —CH 2 —CH 2 —; 
         L 4  is a group selected from 
       
       
         
           
           
               
               
           
         
         wherein the bond marked with the asterisk is attached to the azabicycloalkyl moiety; 
         R 1  is methyl; 
         X 1  is —O— or —NH—; 
         A 2  is selected from 
       
       
         
           
           
               
               
           
         
         wherein the bond marked with the asterisk is attached to X 1 ; 
         A 1  is phenyl, indole or 1,3-dihydro-indol-2-one, which may be substituted once or more than once by R 2 , each R 2  independently is C 1-6  alkyl, C 1-6  halogenalkyl or halogen; or 
         (ii) a compound selected from the group consisting of 
         4-(5-phenyl-1,3,4-thiadiazol-2-yloxy)-1 azatricyclo[3.3.1.1 3,7 ]decane; 
         (4S)-4-(5-phenyl-1,3,4-thiadiazol-2-yloxy)-1azatricyclo[3.3.1.1 3,7 ]decane; 
         4-(6-(1H-indol-5-yl)-pyridazin-3-yloxy)-1 azatricyclo[3.3.1.1 3,7 ]decane; 
         4-(6-(1H-indol-5-yl)-pyridin-3-yloxy)-1 azatricyclo[3.3.1.1 3,7 ]decane; 
         4-(5-(1H-indol-5-yl)-pyrimidin-2-yloxy)-1 azatricyclo[3.3.1.1 3,7 ]decane; 
         N-(1-azabicyclo[2.2.2]oct-3-yl)-1H-indazole-3-carboxamide; 
         N-((3R)-1-azabicyclo[2.2.2]oct-3-yl)-1H-indazole-3-carboxamide 
         N-((3S)-1-azabicyclo[2.2.2]oct-3-yl)-1H-indazole-3-carboxamide 
         N-(1-azabicyclo[2.2.2]oct-3-yl)-5-(trifluoromethoxy)-1H-indazole-3-carboxamide; 
         N-((3R)-1-azabicyclo[2.2.2]oct-3-yl)-5-(trifluoromethoxy)-1H-indazole-3-carboxamide; 
         N-((3S)-1-azabicyclo[2.2.2]oct-3-yl)-5-(trifluoromethoxy)-1H-indazole-3-carboxamide; 
         N-(2-((3-pyridinyl)methyl)-1-azabicyclo[2.2.2]oct-3-yl)benzofuran-2-carboxamide; 
         (2S,3R)—N-(2-((3-pyridinyl)methyl)-1-azabicyclo[2.2.2]oct-3-yl)benzofuran-2-carboxamide; 
         N-(2-((3-pyridinyl)methyl)-1-azabicyclo[2.2.2]oct-3-yl)-3,5-difluorobenzamide; 
         (2S,3R)—N-(2-((3-pyridinyl)methyl)-1-azabicyclo[2.2.2]oct-3-yl)-3,5-difluorobenzamide; 
         N-(2-((3-pyridinyl)methyl)-1-azabicyclo[2.2.2]oct-3-yl)-5-methylthiophene-2-carboxamide; 
         (2S,3R)—N-(2-((3-pyridinyl)methyl)-1-azabicyclo[2.2.2]oct-3-yl)-5-methylthiophene-2-carboxamide; 
         N-(2-((3-pyridinyl)methyl)-1-azabicyclo[2.2.2]oct-3-yl)-5-(2-pyridinyl)thiophene-2-carboxamide; 
         (2S,3R)—N-(2-((3-pyridinyl)methyl)-1-azabicyclo[2.2.2]oct-3-yl)-5-(2-pyridinyl)thiophene-2-carboxamide; 
         7,8,9,10-tetrahydro-6,10-methano-6H-pyrazino-(2,3-h)(3)-benzazepine; 
         3-[1-(2,4-Dimethoxy-phenyl)-meth-(E)-ylidene]-3,4,5,6-tetrahydro-[2,3′]bipyridinyl; 
         N-methyl-1-{5-[3′H-spiro[4-azabicyclo[2.2.2]octane-2,2′-furo[2,3-b]pyridin]-5′-yl]-2-thienyl}methanamine; 
         N-methyl-1-{5-[(2R)-3′H-spiro[4-azabicyclo[2.2.2]octane-2,2′-furo[2,3-b]pyridin]-5′-yl]-2-thienyl}methanamine; 
         N-methyl-1-{5-[(2S)-3′H-spiro[4-azabicyclo[2.2.2]octane-2,2′-furo[2,3-b]pyridin]-5′-yl]-2-thienyl}methanamine; 
         (R)-7-chloro-N-(quinuclidin-3-yl)benzo[b]thiophene-2-carboxamide; 
         5-{5-[(endo)-8-azabicyclo[3.2.1]octan-3-yloxy]pyridin-2-yl}-1H-indole; 
         5-{5-[(exo)-8-azabicyclo[3.2.1]octan-3-yloxy]pyridin-2-yl}-1H-indole; 
         5-{5-[(endo)-8-methyl-8-aza-bicyclo[3.2.1]oct-3-yloxy]pyridin-2-yl}-1H-indole; 
         5-{5-[(exo)-8-methyl-8-aza-bicyclo[3.2.1]oct-3-yloxy]pyridin-2-yl}-1H-indole; 
         4-{5-[(exo)-8-methyl-8-aza-bicyclo[3.2.1]oct-3-yloxy]pyridin-2-yl}-1H-indole; 
         5-{6-[(exo)-8-methyl-8-aza-bicyclo[3.2.1]oct-3-yloxy]pyridin-3-yl}-1H-indole; 
         (2′R)-spiro-[1-azabicyclo[2.2.2]octane-3,2′(3′H)-furo[2,3-b]pyridine]; 
         1,4-Diaza-bicyclo[3.2.2]nonane-4-carboxylic acid 4-bromo-phenyl ester; and 
         5-{6-[1-azabicyclo[2.2.2]oct-3-yloxy]pyridazin-3-yl}-1H-indole; 
         in free base form or in acid addition salt form. 
       
     
     
         32 . The alpha 7 nicotinic acetylcholine receptor agonist as defined in  claim 31  for use in the treatment, amelioration, prevention or delay of progression of narcolepsy, wherein the narcolepsy is one of: narcolepsy with cataplexy, narcolepsy without cataplexy, or narcolepsy due to a medical condition. 
     
     
         33 - 35 . (canceled) 
     
     
         36 . An alpha 7 nicotinic acetylcholine receptor agonist as defined in  claim 31  for use in the treatment, amelioration, prevention or delay of progression of excessive daytime sleepiness, nocturnal sleep disruption, or cataplexy. 
     
     
         37 - 40 . (canceled) 
     
     
         41 . The alpha 7 nicotinic acetylcholine receptor agonist as defined in  claim 31 , wherein the agonist is (R)-3-(6-p-tolyl-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane in free base form or in acid addition salt form and wherein the daily dosage of said agonist is from 1 to 100 mg. 
     
     
         42 - 48 . (canceled)

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