Compositions comprising nicotinic agonists and methods of using same

Abstract

The disclosure is directed at least in part to compositions and methods comprising nicotinic agonists for treating e.g., nervous system disorders, in particular, to combination therapies that include a nicotinic agonist (for example, nicotine) and a nicotinic acetylcholine receptor desensitization inhibitor (for example, opipramol).

1 - 4 . (canceled) 
     
     
         5 . A method of treating or suppressing tobacco or nicotine dependence or usage, comprising co-administering to a patient in need thereof a therapeutically effective amount of a nicotinic agonist and a nicotinic acetylcholine receptor (nAChR) desensitization inhibitor. 
     
     
         6 - 32 . (canceled) 
     
     
         33 . The method of  claim 5 , wherein the nAChR desensitization inhibitor is selected from the group consisting of: opipramol, galantamine, clomipramine, mirtazapine, maprotiline, lidocaine, and pharmaceutically acceptable salts, esters, and prodrugs thereof. 
     
     
         34 . The method of  claim 5 , wherein the nicotinic agonist is nicotine and the nAChR densitization inhibitor is opipramol or a pharmaceutically acceptable salt or ester thereof. 
     
     
         35 . The method of  claim 34 , wherein about 5 mg/day to about 21 mg/day of the nicotine is administered. 
     
     
         36 . The method of  claim 34 , wherein about 50 mg/day to about 250 mg/day of opipramol is administered. 
     
     
         37 . The method of  claim 5 , wherein the nicotinic agonist is effective for at least about 1 day. 
     
     
         38 . The method of  claim 5 , wherein the nicotinic agonist is effective for at least about 3 days. 
     
     
         39 - 56 . (canceled) 
     
     
         57 . A transdermal patch for administration of a co-therapy to a patient, wherein said patch comprises:
 a) nicotine,   b) opipramol or pharmaceutically acceptable salts, esters, and prodrugs thereof, and   c) a pharmaceutically acceptable carrier suitable for transdermal or topical administration to a patient.   
     
     
         58 . The transdermal patch of  claim 57 , wherein the patch is formulated to provide substantially continuous delivery of the nicotine and the opipramol to a patient. 
     
     
         59 - 61 . (canceled) 
     
     
         62 . A controlled release medical device for delivery of a composition comprising:
 a) nicotine, and   b) opipramol or a pharmaceutically acceptable salt, ester, or a prodrug thereof; wherein the device is capable of delivering the composition in a pre-determined delivery rate to a patient.   
     
     
         63 . The controlled release medical device of  claim 62 , wherein the pre-determined delivery rate is substantially continuously over at least 1 day. 
     
     
         64 . The controlled release medical device of  claim 63 , wherein the pre-determined delivery rate is substantially continuously over at least 1 day. 
     
     
         65 . A kit comprising:
 a first pharmaceutical composition comprising a nicotinic agonist,   a second pharmaceutical composition comprising a nAChR desensitization inhibitor, and   instructions for administration of the first and second compositions.   
     
     
         66 . The kit of  claim 65 , wherein the first and second compositions form a transdermal patch.