Cannabinoid receptor agonists and serine hydrolase enzyme inhibitor based anxiolytic therapeutic product

Abstract

Provided herein are formulations for treating affective mood disorders. The formulations comprise one or more than one CB receptor agonist and one or more than one serine hydrolase enzyme inhibitor.

What is claimed is: 
     
         1 . A method of treating an affective disorder by administering to a subject in need thereof a formulation comprising in combination:
 i) an effective amount of one or more than one CB receptor agonist; and   ii) an effective amount of one or more than one serine hydrolase enzyme inhibitor.   
     
     
         2 . The method of  claim 1 , wherein the combination of the one or more than one CB receptor agonist, and the one or more than one serine hydrolase enzyme inhibitor is a synergistic combination. 
     
     
         3 . The method of  claim 1 , wherein the one or more than one CB receptor agonist is one or more than one cannabinoid. 
     
     
         4 . The method of  claim 3 , wherein the one or more than one cannabinoid is an anxiolytic cannabinoid. 
     
     
         5 . The method of  claim 3 , where the one or more than one cannabinoid is cannabidiol (CBD). 
     
     
         6 . The method of  claim 5 , wherein the effective amount of CBD is between 0.01 mg and 1000 mg. 
     
     
         7 . The method of  claim 1 , wherein the one or more than one serine hydrolase enzyme inhibitor is one or more than one monoacylglycerol lipase (MAGL) inhibitor. 
     
     
         8 . The method of  claim 7 , wherein the effective amount of the one or more MAGL inhibitor is between 0.01 mg and 1000 mg. 
     
     
         9 . The method of  claim 7 , where the one or more than one MAGL inhibitor is KML29, JZL184, or a combination thereof. 
     
     
         10 . The method of  claim 1 , wherein the affective disorder comprises anxiety, generalized anxiety disorder, phobias, panic disorder, panic attacks, obsessive-compulsive disorder, post-traumatic stress disorder (PTSD), separation anxiety disorder, situational anxiety disorder, stress or a combination thereof. 
     
     
         11 . The method of  claim 1 , wherein the one or more than one CB receptor agonist and the one or more than one serine hydrolase enzyme inhibitor is present in an effective amount to improve the therapeutic outcome and reduced dosage of the one or more than one CB receptor agonist and/or one or more than one serine hydrolase enzyme inhibitor. 
     
     
         12 . The method of  claim 1 , wherein the treating comprises an extended treatment period or a protracted treatment period. 
     
     
         13 . The method of  claim 12 , wherein the extended treatment period is at least 21 days. 
     
     
         14 . The method of  claim 12 , wherein the protracted treatment period comprises between about 1 to about 21 days or any amount of days therebetween. 
     
     
         15 . The method of  claim 1 , wherein the formulation is administered transmucosally or orally. 
     
     
         16 . The method of  claim 15 , wherein transmucosal administration is sublingual, buccal, nasal, ocular, vaginal, and/or rectal mucosae. 
     
     
         17 . The method of  claim 1 , wherein the formulation is delivered in an appropriate aerosol, liquid, gel, film, or tablet/solid drug carrier with drug stabilizers/additives. 
     
     
         18 . A method of treating an affective disorder by administering to a subject in need thereof a pharmaceutical preparation comprising in combination:
 i) an effective amount of one or more than one CB receptor agonist;   ii) an effective amount of one or more than one serine hydrolase enzyme inhibitor; and   a physiologically acceptable surface-active agents, carriers, diluents, excipients, smoothing agents, suspension agents, film forming substances, and coating assistants, or a combination thereof.   
     
     
         19 . The method of  claim 18 , wherein the treating comprises an extended treatment period or a protracted treatment period. 
     
     
         20 . The method of  claim 18 , wherein the pharmaceutical preparation is administered transmucosally or orally.