USE OF (+)-1-(3,4-DICHLOROPHENYL)-3-AZABICYCLO[3.1.0]HEXANE TO TREAT ADDICTIVE DISORDERS INCLUDING NICOTINE ADDICTION
The present invention relates to (+)-1-(3,4-dichlorophenyl)-3-azabicyclo[3.1.0]hexane and pharmaceutically acceptable active salts, polymorphs, glycosylated derivatives, metabolites, solvates, hydrates, and/or prodrugs of (+)-1-(3,4-dichlorophenyl)-3-azabicyclo[3.1.0]hexane and their use alone or in combination with additional anti-addictive compositions in the treatment of nicotine addiction and related disorders.
1 - 21 . (canceled)
22 . A method for treating a nicotine-related disorder in a human subject in need thereof, comprising administering to the subject 100 to 250 mg of (+)-1-(3,4-dichlorophenyl)-3-azabicyclo[3.1.0]hexane or a pharmaceutically acceptable salt thereof substantially free of (−)-1-(3,4-dichlorophenyl)-3-azabicyclo[3.1.0]hexane or a pharmaceutically acceptable salt thereof.
23 . The method according to claim 22 , wherein the (+)-1-(3,4-dichlorophenyl)-3-azabicyclo[3.1.0]hexane or pharmaceutically acceptable salt thereof has no more than about 2% w/w of (−)-1-(3,4-dichlorophenyl)-3-azabicyclo[3.1.0]hexane or pharmaceutically acceptable salt thereof.
24 . The method according to claim 22 , wherein the (+)-1-(3,4-dichlorophenyl)-3-azabicyclo[3.1.0]hexane or pharmaceutically acceptable salt thereof has no more than about 1% w/w of (−)-1-(3,4-dichlorophenyl)-3-azabicyclo[3.1.0]hexane or pharmaceutically acceptable salt thereof.
25 . The method according to claim 22 , wherein the nicotine-related disorder is selected from the group consisting of Nicotine Dependence, Nicotine Withdrawal, Nicotine Cessation, Nicotine Relapse, and Nicotine-Related Disorder not otherwise specified (NOS).
26 . The method according to claim 22 further comprising coordinately administering a secondary therapeutic agent.
27 . The method according to claim 26 , wherein the secondary therapeutic agent is an anti-nicotine agent.
28 . The method according to claim 27 , wherein the anti-nicotine agent is selected from the group consisting of varenicline, bupropion, cytisine, anabasine, nortriptyline, mecamylamine, and clonidine.
29 . The method according to claim 26 , wherein the subject is effectively treated for a secondary, co-morbid central nervous system (CNS) condition or addictive disorder selected from the group consisting of depression, anxiety, and psychosis.
30 . The method according to claim 26 , wherein the secondary therapeutic agent is an anti-depressant.
31 . The method according to claim 26 , wherein the secondary therapeutic agent is an anti-psychotic drug.
32 . The method according to claim 26 , wherein the secondary therapeutic agent is an anxiolytic agent.
33 . A method for treating nicotine consumption or addiction comprising administering to a patient in need thereof 100 to 250 mg of (+)-1-(3,4-dichlorophenyl)-3-azabicyclo[3.1.0]hexane or a pharmaceutically acceptable salt thereof substantially free of (−)-1-(3,4-dichlorophenyl)-3-azabicyclo[3.1.0]hexane or a pharmaceutically acceptable salt thereof.
34 . The method according to claim 33 , wherein the (+)-1-(3,4-dichlorophenyl)-3-azabicyclo[3.1.0]hexane or pharmaceutically acceptable salt thereof has no more than about 2% w/w of (−)-1-(3,4-dichlorophenyl)-3-azabicyclo[3.1.0]hexane or pharmaceutically acceptable salt thereof.
35 . The method according to claim 33 , wherein the (+)-1-(3,4-dichlorophenyl)-3-azabicyclo[3.1.0]hexane or pharmaceutically acceptable salt thereof has no more than about 1% w/w of (−)-1-(3,4-dichlorophenyl)-3-azabicyclo[3.1.0]hexane or pharmaceutically acceptable salt thereof.
36 . The method according to claim 33 further comprising coordinately administering a secondary therapeutic agent.
37 . The method according to claim 36 , wherein the secondary therapeutic agent is an anti-nicotine agent.
38 . The method according to claim 37 , wherein the anti-nicotine agent is selected from the group consisting of varenicline, bupropion, cytisine, anabasine, nortriptyline, mecamylamine, and clonidine.
39 . The method according to claim 22 , wherein the effective amount of (+)-1-(3,4-dichlorophenyl)-3-azabicyclo[3.1.0]hexane or pharmaceutically acceptable salt thereof substantially free of (−)-1-(3,4-dichlorophenyl)-3-azabicyclo[3.1.0]hexane or pharmaceutically acceptable salt thereof is administered in a sustained release formulation.