Cannabinoids in the treatment of autism spectrum disorder

Abstract

A method of treating autism spectrum disorder (ASD) in a subject, whereby the subject in need thereof is administered, via the oral mucosa, a rapidly infusing composition that includes (a) a pharmaceutically acceptable binder and/or excipient system containing gelatin and a sugar alcohol, and (b) a therapeutically effective amount of cannabidiol (CBD) or a derivative/analog thereof.

1 . A method of treating symptoms of autism spectrum disorder in a subject, comprising:
 administering to the subject in need thereof, via the oral mucosa, a rapidly infusing composition comprising (a) a pharmaceutically acceptable binder and/or excipient system comprising gelatin and a sugar alcohol, and (b) a therapeutically effective amount of cannabidiol (CBD) or a derivative/analog thereof.   
     
     
         2 . The method of  claim 1 , wherein the rapidly infusing composition is lyophilized. 
     
     
         3 . The method of  claim 1 , wherein the rapidly infusing composition has a disintegration time of approximately 1 to 30 seconds in deionized water maintained at 37° C.±2° C. 
     
     
         4 . The method of  claim 1 , wherein the rapidly infusing composition has a disintegration time of approximately 1 to 5 seconds in deionized water maintained at 37° C.±2° C. 
     
     
         5 . The method of  claim 1 , wherein the gelatin is present in the rapidly infusing composition in an amount of 10 to 35 wt. %, based on a total weight of the rapidly infusing composition on a dry basis. 
     
     
         6 . The method of  claim 1 , wherein the gelatin is mammalian gelatin. 
     
     
         7 . The method of  claim 1 , wherein the gelatin is bovine gelatin. 
     
     
         8 . The method of  claim 1 , wherein the sugar alcohol is present in the rapidly infusing composition in an amount of 5 to 35 wt. %, based on a total weight of the rapidly infusing composition on a dry basis. 
     
     
         9 . The method of  claim 1 , wherein the sugar alcohol comprises mannitol. 
     
     
         10 . The method of  claim 1 , wherein the CBD or derivative/analog thereof is present in the rapidly infusing composition in an amount of 20 to 70 wt. %, based on a total weight of the rapidly infusing composition on a dry basis. 
     
     
         11 . The method of  claim 1 , wherein the rapidly infusing composition is formulated with a solid form of the CBD. 
     
     
         12 . The method of  claim 1 , wherein the rapidly infusing composition is formulated with a solid form of the CBD having a purity between 95 and 99.9 wt. %. 
     
     
         13 . The method of  claim 1 , wherein the rapidly infusing composition is formulated with a solid form of the CBD that has been micronized to have a D50 diameter between 1 and 50 μm. 
     
     
         14 . The method of  claim 1 , wherein the rapidly infusing composition is formulated with a CBD derivative/analog. 
     
     
         15 . The method of  claim 14 , wherein the CBD derivative/analog is cannabidiolic acid methyl ester. 
     
     
         16 . The method of  claim 1 , wherein the rapidly infusing composition further comprises at least one selected from the group consisting of a sweetener, a flavorant, and a colorant. 
     
     
         17 . The method of  claim 16 , wherein the rapidly infusing composition comprises the flavorant, and the flavorant comprises lemon-lime flavor. 
     
     
         18 . The method of  claim 16 , wherein the rapidly infusing composition comprises the colorant, and the colorant comprises FD&C Yellow #5. 
     
     
         19 . The method of  claim 16 , wherein the rapidly infusing composition comprises the sweetener, and the sweetener comprises a mixture of sucralose and acesulfame-K. 
     
     
         20 . The method of  claim 1 , wherein the rapidly infusing composition is administered to the subject via the buccal mucosa. 
     
     
         21 . The method of  claim 1 , wherein the therapeutically effective amount of CBD or derivative/analog thereof is from 0.1 mg/kg/day to less than 5 mg/kg/day. 
     
     
         22 . The method of  claim 1 , wherein the rapidly infusing composition is administered to the subject 1 to 3 times per day. 
     
     
         23 . The method of  claim 1 , wherein the rapidly infusing composition further comprises a therapeutically effective amount of an antipsychotic agent. 
     
     
         24 . The method of  claim 23 , wherein the antipsychotic agent is risperidone. 
     
     
         25 . The method of  claim 24 , wherein the therapeutically effective amount of risperidone is from 0.25 mg to 20 mg per day. 
     
     
         26 . The method of  claim 23 , wherein the antipsychotic agent is aripiprazole. 
     
     
         27 . The method of  claim 26 , wherein the therapeutically effective amount of aripiprazole is from 1 mg to 30 mg per day. 
     
     
         28 . The method of  claim 1 , wherein the subject presents with at least one symptom selected from the group consisting of stereotypic behavior, underdeveloped motor skills, atypical nonverbal behaviors, self-injurious behavior (SIB), restlessness, hyperactivity, sleep deprivation, lethargy, anxiety, psychosis, seizures, disruptive behaviors, irritability or severe mood dysregulation, aggression, agitation, challenges with social interaction, impaired communication, noncompliance, resistance to change in routine, and unusual sensory reactivity. 
     
     
         29 . The method of  claim 1 , wherein the subject is comorbid with both ASD and epilepsy. 
     
     
         30 . The method of  claim 29 , wherein the epilepsy is one or more of childhood epilepsy, drug resistant epilepsy, and epilepsy that presents with atonic seizures. 
     
     
         31 . The method of  claim 29 , wherein a total convulsive frequency of the subject is reduced by at least 50%, relative to the total convulsive frequency observed prior to administration of the rapidly infusing composition. 
     
     
         32 . The method of  claim 29 , wherein a total convulsive frequency of the subject is reduced by at least 70%, relative to the total convulsive frequency observed prior to administration of the rapidly infusing composition. 
     
     
         33 . The method of  claim 1 , wherein the rapidly infusing composition is administered in combination with a second therapeutic agent. 
     
     
         34 . The method of  claim 33 , wherein the second therapeutic agent is an antidepressant, an anxiolytic, an antipsychotic, a stimulant, a cognition-enhancing medication, or an antiepileptic drug.