CANNABINOIDS IN THE TREATMENT OF EPILEPSY
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).
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.