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Use of the phytocannabinoid cannabidiol (CBD) in combination with a standard Anti-epileptic drug (SAED) in the treatment of epilepsy

a technology of phytocannabinoid cannabidiol and epilepsy, which is applied in the direction of biocide, plant/algae/fungi/lichens, drug compositions, etc., can solve the problems that the selective benefits of cbd with e.g. ethosuximide and valporate (saed's with defined sodium channels) cannot be anticipated, and achieve the effect of reducing the severity and mortality of seizures

Inactive Publication Date: 2014-06-05
GW PHARMA LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0041]reduces high-frequency neuronal firing and sodium-dependent action potentials (and may additionally enhance GABA effects), such as, valproate;In contrast, a SAED which (solely) enhances GABAergic inhibition (as opposed to acting via sodium or calcium channels), such as, phenobarbital, does not appear to provide benefits in combination with CBD, when tested in a pilocarpine model. Thus, the selective benefits of CBD with e.g. ethosuximide and valporate (SAED's with defined and distinct mechanisms of actions involving calcium and sodium channels) could not be anticipated.
[0050]b. increasing the amount of time a patient is seizure free;
[0053]e. reducing the severity and mortality of the seizures.Thus, the combinations are particularly well suited in the treatment of conditions generally considered refractory to existing medication. The combinations would also appear to allow for the use of lower doses of the SAED's than would be used were the SAED to be used alone.

Problems solved by technology

Thus, the selective benefits of CBD with e.g. ethosuximide and valporate (SAED's with defined and distinct mechanisms of actions involving calcium and sodium channels) could not be anticipated.

Method used

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  • Use of the phytocannabinoid cannabidiol (CBD) in combination with a standard Anti-epileptic drug (SAED) in the treatment of epilepsy
  • Use of the phytocannabinoid cannabidiol (CBD) in combination with a standard Anti-epileptic drug (SAED) in the treatment of epilepsy
  • Use of the phytocannabinoid cannabidiol (CBD) in combination with a standard Anti-epileptic drug (SAED) in the treatment of epilepsy

Examples

Experimental program
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Effect test

example 1

[0070]The Use of the Phytocannabinoid CBD in Combination with a Standard Anti-Epileptic Drug (SAED) in the PTZ-Model of Epilepsy

Methodology:

Animals:

[0071]Male Wistar rats (P24-29; 75-110 g) were used to assess the effects of the phytocannabinoid CBD in combination with SAEDs in the PTZ model of generalised seizures. Animals were habituated to the test environment, cages, injection protocol and handling prior to experimentation. Animals were housed in a room at 21° C. on a 12 hour light: dark cycle (lights on 0900) in 50% humidity, with free access to food and water.

[0072]The human dose equivalent (HED) can be estimated using the following formula:

HED=Animaldose(mg / kg)multipliedbyAnimalKmHumanKm[0073]The Km for a rat is 6 and the Km for a human is 37.

Thus, for a human of approx 60 Kg a 100 mg / Kg dose in rat would equate to a human dose of about 1000 mg. Human doses of greater than 300 mg / day, through 400 mg / day in 100 mg intervals (namely through 500, 600, 700, 800, 900, 1000, 1100, ...

example 2

[0088]The Use of the Phytocannabinoid CBD in Combination with a Standard Anti-Epileptic Drug (SAED) in the Pilocarpine Model of (Temporal Lobe) Epilepsy

Methodology:

[0089]Isolated CBD was injected intra-peritoneally (IP) in the standard vehicle (1:1:18 ethanol:Cremophor:0.9% w / v NaCl) at doses of 50, 100 and 200 mg / kg alongside animals that received vehicle alone at a matched volume. 15 minutes later methylscopolamine (1 mg / kg; to reduce peripheral muscarinic effects of pilocarpine) was administered followed, 45 minutes later by pilocarpine (380 mg / kg, IP) administration.

Results:

[0090]FIG. 4 demonstrates the anti-convulsant effects of a combination of CBD and valproate in the pilocarpine model of epilepsy. These data show that the combination of the CBD and valproate was able to increase the latency of onset of the seizure.

[0091]It can be seen from the data illustrated in FIG. 5 that in addition to increasing the latency of onset of the seizure the combination of CBD and valproate wa...

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Abstract

The invention relates to the use of cannabidiol (CBD), at a dose of greater than 300 mg / day, in combination with a standard anti-epileptic drug (SAED) which acts via sodium or calcium channels, for use in the treatment of epilepsy. The SAED is preferably one which•modifies low-threshold or transient neuronal calcium currents,or•reduces high-frequency neuronal firing and sodium-dependent action potentials and enhances GABA effects. Preferred SAEDs are ethosuximide and valproate.

Description

[0001]This invention relates to the use of the phytocannabinoid cannabidiol (CBD) in combination with a standard anti-epileptic drug (SAED). Preferably the CBD is used in combination with a SAED with a mechanism of action which acts via sodium or calcium channels, more preferably one which:[0002]modifies low-threshold or transient neuronal calcium currents, as exemplified by ethosuximide; or[0003]reduces high-frequency neuronal firing and sodium-dependent action potentials and may additionally enhance GABA effects, as exemplified by valproate.BACKGROUND[0004]Epilepsy is a chronic neurological disorder presenting a wide spectrum of diseases that affect approximately 50 million people worldwide (Sander, 2003). Advances in the understanding of the body's internal ‘endocannabinoid’ system has lead to the suggestion that cannabis-based medicines may have the potential to treat this disorder of hyperexcitability in the central nervous system (Mackie, 2006, Wingerchuk, 2004, Alger, 2006).[...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/05A61K31/4015A61K31/19A61K45/06
CPCA61K31/05A61K31/19A61K31/4015A61K45/06A61K2300/00A61K31/352A61K31/515A61P25/08A61K36/185A61K36/00
Inventor WHALLEY, BENWILLIAMS, CLAIRESTEPHENS, GARY
Owner GW PHARMA LTD
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