US2022202738A1PendingUtilityA1

Cannabinoids in the treatment of epilepsy

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Assignee: GW RES LTDPriority: Jun 17, 2014Filed: Mar 8, 2022Published: Jun 30, 2022
Est. expiryJun 17, 2034(~7.9 yrs left)· nominal 20-yr term from priority
Inventors:Geoffrey GuyStephen WrightOrrin Devinsky
A61K 36/3482A61K 36/185A61K 31/658A61K 31/27A61K 9/08A61K 31/53A61K 31/423A61P 25/00A61K 31/195A61P 25/08A61K 31/4015A61K 31/5517A61K 31/165A61K 31/35A61K 31/36A61P 43/00A61K 31/55A61K 31/551A61K 31/197A61K 47/26A61K 31/515A61K 31/20A61K 31/19A61K 47/10A61K 31/5513A61K 31/7048A61K 31/444A61K 47/44A61K 31/4166A61P 25/10A61K 31/496A61K 45/06A61K 9/0053A61K 31/352A61K 31/05
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Claims

Abstract

The present disclosure relates to the use of cannabidiol (CBD) in the treatment of absence seizures. In particular, the disclosure relates to the use of CBD for reducing absence seizures in patients suffering with etiologies that include: Lennox-Gastaut Syndrome; Tuberous Sclerosis Complex; Dravet Syndrome; Doose Syndrome; CDKL5; Dup15q; Jeavons syndrome; Myoclonic Absence Epilepsy; Neuronal ceroid lipofuscinoses (NCL) and brain abnormalities. The disclosure further relates to the use of CBD in combination with one or more anti-epileptic drugs (AEDs).

Claims

exact text as granted — not AI-modified
1 . A method of treating absence seizures in a subject diagnosed with Lennox-Gastaut Syndrome, Myoclonic Absence Epilepsy, or Dravet Syndrome, comprising administering to the subject a drug product comprising a cannabidiol (CBD) drug substance, wherein the CBD is administered at a starting dose of about 5 mg/kg/day, and the starting dose is gradually increased by 2-5 mg/kg increments up to a maximum dose of 25 mg/kg/day, wherein the CBD drug substance has a purity of at least 98% (w/w) CBD and comprises no more than 0.15% (w/w) Δ9-tetrahydrocannabidiol. 
     
     
         2 . The method according to  claim 1 , wherein the absence seizures are myoclonic absence seizures. 
     
     
         3 . The method according to  claim 1 , wherein the epilepsy is treatment-resistant epilepsy (TRE). 
     
     
         4 . The method according to  claim 1 , wherein the CBD is administered in combination with one or more concomitant anti-epileptic drugs (AED). 
     
     
         5 . The method according to  claim 1 , wherein the subject is diagnosed with Lennox-Gastaut Syndrome. 
     
     
         6 . The method according to  claim 1 , wherein the subject is diagnosed with Dravet Syndrome. 
     
     
         7 . The method according to  claim 1 , wherein the subject is diagnosed with Myoclonic Absence Epilepsy. 
     
     
         8 . The method according to  claim 1 , wherein the CBD is a highly purified extract of cannabis. 
     
     
         9 . The method according to  claim 8 , wherein the extract further comprises up to 1% CBDV. 
     
     
         10 . The method according to  claim 1 , wherein the CBD is present as a synthetic compound. 
     
     
         11 . The method according to  claim 4 , wherein the one or more concomitant AED is selected from the group consisting of: sodium valproate; lamotrigine; clobazam; and clonazepam. 
     
     
         12 . The method according to  claim 4 , wherein the number of different concomitant anti-epileptic drugs that are used in combination with the CBD is reduced compared to the number of concomitant anti-epileptic drugs that are used prior to administering CBD. 
     
     
         13 . The method according to  claim 4 , wherein the dose of the concomitant AED that are used in combination with the CBD is reduced. 
     
     
         14 . The method according to  claim 5 , wherein the dose of CBD is increased to 10 mg/kg/day. 
     
     
         15 . The method according to  claim 5 , wherein the dose of CBD is increased to 20 mg/kg/day. 
     
     
         16 . The method according to  claim 6 , wherein the dose of CBD is increased to 10 mg/kg/day. 
     
     
         17 . The method according to  claim 6 , wherein the dose of CBD is increased to 20 mg/kg/day. 
     
     
         18 . The method according to  claim 1 , wherein the dose of CBD is increased to 10 mg/kg/day. 
     
     
         19 . The method according to  claim 1 , wherein the dose of CBD is increased to 20 mg/kg/day. 
     
     
         20 . The method according to  claim 1 , wherein the dose of CBD is increased by 5 mg/kg increments. 
     
     
         21 . The method according to  claim 5 , wherein the dose of CBD is increased by 5 mg/kg increments. 
     
     
         22 . The method according to  claim 6 , wherein the dose of CBD is increased by 5 mg/kg increments. 
     
     
         23 . The method according to  claim 1 , wherein the drug product is an oral solution. 
     
     
         24 . The method according to  claim 23 , wherein the oral solution comprises ethanol, a sweetener, fruit flavoring, and sesame oil. 
     
     
         25 . The method according to  claim 23 , wherein the CBD is present in the oral solution at about 100 mg/mL.

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