COMPOSITION AND METHOD FOR TREATING AUTISM
The invention relates to pharmaceutical compositions comprising cannabidiol (CBD) and Δ 9 -tetrahydrocannabinol (THC), and their use in the treatment of autism. The invention also relates to methods for treating autism.
1 . A pharmaceutical composition comprising cannabidiol (CBD) and Δ 9 -tetrahydrocannabinol (THC) in a ratio of CBD:THC from about 4:1 to about 1:4, one or more terpene or terpenoid compounds and optionally one or more pharmaceutically acceptable carriers, diluents, adjuvants, excipients or any combination thereof.
2 . The composition of claim 1 , wherein the pharmaceutical composition comprises a Cannabis extract comprising the CBD and the THC.
3 . The composition of claim 2 , wherein the Cannabis extract further comprises the one or more terpenes and/or terpenoids.
4 . The composition of claim 2 , wherein the Cannabis extract is macerated oil or a resin.
5 . The composition of claim 2 , wherein the Cannabis extract is formed by alcohol extraction of Cannabis plant material.
6 . The composition of claim 5 , wherein the alcohol is ethanol.
7 . The composition of claim 4 or 5 , wherein the Cannabis plant material used to form the extract is dried prior to extraction.
8 . The composition of claim 1 , further comprising cannabigerol.
9 . The composition of claim 1 , wherein the composition is formulated for sublingual administration.
10 . The composition of claim 1 , wherein the pharmaceutical composition is in the form of a liquid.
11 . The composition of claim 1 , comprising a carrier selected from olive oil, hemp oil, sesame oil, coconut oil, vegetable oil, canola oil, grape seed oil, almond oil, medium-chain triglyceride (MCT) oil, or a combination thereof.
12 . A method for treating autism, comprising administering to a patient in need thereof an effective amount of the pharmaceutical composition according to claim 1 .
13 . A method for treating autism according to claim 12 comprising treatment of a symptom of autism or a symptom associated with autism selected from reduced sociability, tantrums, poor use of language, repetitive behavior, self-injurious behavior, irritability, hyperactivity, poor ability to focus, unexplained weight loss, fever, fatigue, pain, and skin changes or a combination thereof.
14 . The method of claim 12 , wherein treatment is maintained for at least about 12 weeks.
15 . The method of claim 12 , wherein THC is administered in an amount of less than about 10 mg/day.
16 . The method of claim 12 , wherein THC is administered in an amount from about 0.1-10 mg/day.
17 . The method of claim 12 , wherein CBD is administered in an amount of less than about 20 mg/day.
18 . The method of claim 12 , wherein CBD is administered in an amount from about 0.1-20 mg/day.
19 . The method of claim 12 , wherein the pharmaceutical composition is administered twice daily.
20 . The method of claim 12 , wherein the administration is sublingual administration.
21 . (canceled)
22 . (canceled)
23 . (canceled)
24 . (canceled)
25 . (canceled)
26 . (canceled)
27 . A kit comprising in separate parts: (a) CBD, and (b) THC, wherein the amount of CBD in part (a) and the amount of THC in part (b) are in a ratio of CBD:THC from about 4:1 to about 1:4, wherein at least one of (a) and (b) comprises one or more terpene or terpenoid compounds.
28 . (canceled)
29 . (canceled)