Use of cannabinoids in the treatment of epilepsy

Abstract

The present disclosure relates to the use of cannabidiol (CBD) for the reduction of total convulsive seizure frequency in the treatment of “treatment-resistant epilepsy” (TRE). In particular, the disclosure relates to the use of CBD of treating TRE when the TRE is Dravet syndrome; myoclonic absence seizures or febrile infection related epilepsy syndrome (FIRES). The disclosure further relates to the use of CBD in combination with one or more anti-epileptic drugs (AEDs).

1 . A method of treating seizures associated with Lennox Gastaut or Dravet syndrome in a patient in need thereof, comprising administering a pharmaceutical compostrition comprising a purified extract of cannabis which comprises at least 98% w/w cannabidiol (CBD), and at least one of CBDA (cannabidiolic acid), CBDV (cannabidivarin), Δ 9 THC (delta-9 tetrahydrocannabinol), or cannabidiol-C4 (CBD-C4). 
     
     
         2 . The method of  claim 1 , wherein the pharmaceutical composition comprises CBD and two or more cannabinoids selected from the group consisting of CBDA, Δ 9 THC, and CBD-C4. 
     
     
         3 . The method of  claim 1 , wherein the pharmaceutical composition comprises CBD, CBDA, Δ 9 THC, and CBD-C4. 
     
     
         4 . The method of  claim 3 , wherein the pharmaceutical composition comprises not more than 0.15% w/w CBDA. 
     
     
         5 . The method of  claim 3 , wherein the pharmaceutical composition comprises not more than 0.15% w/w Δ 9 THC. 
     
     
         6 . The method of  claim 3 , wherein the pharmaceutical composition comprises not more than 0.5% w/w CBD-C4. 
     
     
         7 . The method of  claim 1 , comprising administering a dose of CBD ranging from about 5 mg/kg/day to about 20 mg/kg/day. 
     
     
         8 . The method of  claim 1 , comprising administering about 5 mg/kg/day of CBD, and then increasing the dose by about 2 mg/kg/day to about 5 mg/kg/day. 
     
     
         9 . The method of  claim 17 , wherein the dose is increased to a maximum of 25 mg/kg/day. 
     
     
         10 . The method of  claim 1 , wherein the seizures are atonic, tonic, tonic-clonic, clonic, myoclonic, or absence seizures. 
     
     
         11 . The method of  claim 1 , wherein the seizures are atonic seizures. 
     
     
         12 . A pharmaceutical composition comprising a purified extract of cannabis which comprises at least 98% w/w cannabidiol (CBD) and at least of CBDA (cannabidiolic acid), CBDV (cannabidivarin), Δ 9 THC (delta-9 tetrahydrocannabinol), or cannabidiol-C4 (CBD-C4). 
     
     
         13 . The pharmaceutical composition of  claim 12 , comprising CBD and two or more cannabinoids selected from the group consisting of CBDA, Δ 9 THC, and CBD-C4. 
     
     
         14 . The pharmaceutical composition of  claim 12 , comprising CBD CBDA, Δ 9 THC, and CBD-C4. 
     
     
         15 . The pharmaceutical composition of  claim 14 , comprising not more than 0.15% w/w CBDA, 
     
     
         16 . The pharmaceutical composition of  claim 14 , comprising not more than 0.15% w/w Δ 9 THC. 
     
     
         17 . The pharmaceutical composition of  claim 14 , comprising not more than 0.5% w/w CBD-C4. 
     
     
         18 . The pharmaceutical composition of  claim 14 , comprising 25±10% mg/mL or 100±10% mg/mL CBD. 
     
     
         19 . The pharmaceutical composition of  claim 14 , comprising 100±10% mg/mL CBD. 
     
     
         20 . The pharmaceutical composition of  claim 14 , comprising 100±10% mg/mL; 79±10% mg/mL ethanol; 0.5±10% mg/mL sucralose; 0.2±10% mg/mL strawberry flavoring; and sesame oil, q.s. to about 1.0 ml.