Granted Patent
B2
US 12,357,586 · App. 17/585,415 · Granted Jul 15, 2025
Use of the phytocannabinoid cannabidiol (CBD) in combination with a standard anti-epileptic drug (SAED) in the treatment of epilepsy
Inventors:
Benjamin Whalley (Reading, GB); Claire Williams (Reading, GB); Gary Stephens (Reading, GB)
Assignee:
JAZZ PHARMACEUTICALS RESEARCH UK LIMITED
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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 •modities 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.
Claims (13)
1. A method for treating epilepsy in a subject in need thereof, comprising:
administering to the subject cannabidiol (CBD), at a dose of greater than 300 mg/day, in combination with valproate.
2. The method of claim 1 , wherein the epilepsy is a generalized seizure or a temporal lobe seizure.
3. The method of claim 1 , wherein the epilepsy is refractory to existing medication.
4. The method of claim 1 , wherein the CBD is administered with one or more other therapeutically effective phytocannabinoids.
5. The method of claim 4 , wherein the one or more other therapeutically effective phytocannabinoids is THCV and/or CBDV.
6. The method of claim 1 , wherein the CBD is an isolated phytocannabinoid.
7. The method of claim 1 , wherein the CBD is in a form of a botanical drug substance.
8. The method of claim 1 , wherein CBD and valproate are administered in a ratio of valproate to CBD of at least 1:1.
9. The method of claim 1 , wherein CBD and valproate are administered in a ratio of valproate to CBD of no more than 3.5:1.
10. The method of claim 1 , wherein CBD and valproate are administered in a ratio of valproate to CBD in the range of 3.5:1 to 1:1.
11. The method of claim 1 , wherein the administration of CBD and valproate results in a lower percentage of tonic-clonic seizures compared to the administration of either CBD or valproate alone.
12. The method of claim 1 , wherein the administration of CBD and valproate results to a patient population results in a higher percentage of seizure-free patients compared to the administration of either CBD or valproate alone.
Assignments (5)
CHANGE OF NAME
Recorded Apr 11, 2025
From: GW PHARMA LIMITED
To: JAZZ PHARMACEUTICALS OPERATIONS UK LIMITED
Reel/Frame 070817/0264 →
CHANGE OF NAME
Recorded Jan 21, 2025
From: GW RESEARCH LIMITED
To: JAZZ PHARMACEUTICALS RESEARCH UK LIMITED
Reel/Frame 069945/0331 →
SECURITY AGREEMENT
Recorded Jul 26, 2024
From: CAVION, INC.; CELATOR PHARMACEUTICALS, INC.; GW PHARMA LIMITED; JAZZ PHARMACEUTICALS, INC.; JAZZ PHARMACEUTICALS IRELAND LIMITED; JAZZ PHARMACEUTICALS RESEARCH UK LIMITED (F/K/A GW RESEARCH LIMITED)
To: U.S. BANK TRUST COMPANY, NATIONAL ASSOCIATION, AS COLLATERAL TRUSTEE
Reel/Frame 068173/0155 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Aug 11, 2023
From: WHALLEY, BEN; WILLIAMS, CLAIRE; STEPHENS, GARY
To: GW PHARMA LIMITED; OTSUKA PHARMACEUTICAL CO. LIMITED
Reel/Frame 064567/0274 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded May 12, 2023
From: OTSUKA PHARMACEUTICAL CO., LTD.
To: GW PHARMA LTD.
Reel/Frame 063631/0588 →
Priority Claims (1)
GB 1100043
· Jan 4, 2011
· national
Continuity (2)
Continuation
13977766
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