IP Library Granted Patent US 11,318,109
Granted Patent B2
US 11,318,109 · App. 16/709,401 · Granted May 3, 2022

Pharmaceutical composition comprising the phytocannabinoids cannabidivarin (CBDV) and cannabidiol (CBD)

Inventors: Benjamin Whalley (Cambridge, GB); Claire Williams (Cambridge, GB); Gary Stephens (Cambridge, GB); Thomas Hill (Cambridge, GB)
Assignees: GW Pharma Limited; Otsuka Pharmaceutical Co., Limited
A61K31/05A61K31/045A61K31/352A61K31/353A61K36/185A61K45/06
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Quick Facts
Patent No.
US 11,318,109
App. No.
16/709,401
Granted
May 3, 2022
Kind
B2
Abstract

This invention relates to a pharmaceutical composition comprising or consisting essentially of the phytocannabinoids cannabidivarin (CBDV) and cannabidiol (CBD). The composition is particularly safe and efficacious for use in the treatment of neurological conditions, characterized by hyper-excitability of the central nervous system, convulsions or seizures such as occur in epilepsy. Preferably the CBDV and the CBD are present with at least one non-cannabinoid component of cannabis such as one or more terpenes or a terpene fraction. More particularly the composition further comprises one or more cannabichromene type compounds. Particularly cannabichromene propyl variant (CBCV) and/or cannabichromene (CBC). More particularly still the composition is absent or substantially absent of other cannabinoids, including in particular tetrahydrocannabinol (THC) and tetrahydrocannabivarin (THCV), which would normally be present in significant amounts in cannabis chemotypes bred to contain a significant amount of CBDV and/or CBD.

Claims (49)

1. A composition comprising or consisting essentially of cannabidivarin (CBDV) and cannabidiol (CBD), wherein the CBDV and CBD are present in a ratio of from 5:1 to 1:1 (CBDV:CBD).

2. The composition as claimed in claim 1 , further comprising one or more excipients.

3. The composition as claimed in claim 1 , further comprising at least one non-cannabinoid component of cannabis.

4. The composition as claimed in claim 3 , wherein at least one non-cannabinoid component of cannabis comprises a terpene.

5. The composition as claimed in claim 1 , wherein the composition further comprises, or consists essentially of CBDV, CBD and one or more cannabichromene type compounds.

6. The composition as claimed in claim 5 , wherein the one or more cannabichromene type compounds is cannabichromene propyl variant (CBCV) and/or cannabichromene (CBC).

7. The composition as claimed in claim 1 , which is absent or substantially absent of any other cannabinoids.

8. The composition as claimed in claim 7 , wherein the any other cannabinoids are tetrahydrocannabivarin (THCV) and/or tetrahydrocannabinol (THC).

9. The composition as claimed in claim 1 , wherein the CBDV and CBD are present in a ratio of 4.5:1 to 2:1 (CBDV:CBD).

10. The composition as claimed in claim 1 , wherein a unit dosage form of the composition comprises from 500 to 2000 mg CBDV.

11. The composition as claimed in claim 1 , wherein a unit dosage form of the composition comprises from 100 to 600 mg CBD.

12. The composition as claimed in claim 1 , wherein the composition is an extract or botanical drug substance (BDS), and wherein the composition is substantially absent of tetrahydrocannabivarin (THCV) and tetrahydrocannabinol (THC).

13. A composition as claimed in claim 12 , wherein the composition further comprises one or more non-cannabinoid component(s).

14. The combination, comprising:

a composition as claimed in claim 1 , and

a standard anti-epileptic drug (SAED),

wherein the combination is configured for use in the treatment of neurological conditions that involve hyper-excitability of the central nervous system, convulsions or seizures.

15. The combination as claimed in claim 14 , wherein the neurological condition is epilepsy.

16. The combination as claimed in claim 15 , wherein the type of epilepsy to be treated is generalised seizure.

17. A method, comprising using a composition as claimed in claim 1 in the manufacture of a medicament for use in the treatment of neurological conditions that involve hyper-excitability of the central nervous system, convulsions or seizures.

18. A method for treating a neurological condition that involves hyper-excitability of the central nervous system, convulsions or seizures in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of a composition as claimed in claim 1 .

19. The method as claimed in claim 18 , wherein the neurological condition is epilepsy.

20. The method as claimed in claim 19 , wherein the type of epilepsy is generalised seizure.

21. The method as claimed in claim 18 , wherein the composition further comprises at least one non-cannabinoid component of cannabis.

22. The method as claimed in claim 21 , wherein at least one non-cannabinoid component of cannabis comprises a terpene.

23. The method as claimed in claim 18 , wherein the composition further comprises one or more cannabichromene type compounds.

24. The method as claimed in claim 18 , wherein the composition further comprises cannabichromene propyl variant (CBCV) and/or cannabichromene (CBC).

25. The method as claimed in claim 18 , wherein the composition is absent or substantially absent of any other cannabinoids.

26. The method as claimed in claim 18 , wherein the composition is absent or substantially absent of tetrahydrocannabivarin (THCV) and/or tetrahydrocannabinol (THC).

27. The method as claimed in claim 18 , wherein the CBDV and CBD are present in the composition in a ratio of 4.5:1 to 2:1 (CBDV:CBD).

28. The method as claimed in claim 18 , wherein a unit dosage form of the composition comprises from 500 to 2000 mg CBDV.

29. The method as claimed in claim 18 , wherein a unit dosage form of the composition comprises from 100 to 600 mg CBD.

30. The method as claimed in claim 18 , wherein a unit dosage form of the composition comprises: (i) from 100 to 600 mg CBD and (ii) from 500 to 2000 mg CBDV.

31. The method as claimed in claim 18 , further comprising administering to the subject a standard anti-epileptic drug (SAED).

32. The composition as claimed in claim 1 , wherein a unit dosage form of the composition comprises: (i) from 100 to 600 mg CBD and (ii) from 500 to 2000 mg CBDV.

33. The composition as claimed in claim 1 , wherein the composition consists essentially of cannabidivarin (CBDV) and cannabidiol (CBD), and wherein the CBDV and CBD are present in a ratio of from 5:1 to 1:1 (CBDV:CBD).

34. The composition as claimed in claim 1 , wherein the composition comprises:

cannabidivarin (CBDV) and cannabidiol (CBD), wherein the CBDV and CBD are present in a ratio of from 5:1 to 1:1 (CBDV:CBD);

one or more cannabichromene type compounds;

at least one non-cannabinoid component of cannabis ; and

one or more excipients, wherein the composition is absent or substantially absent of any other cannabinoids.

35. The method for treating a neurological condition that involves hyper-excitability of the central nervous system, convulsions or seizures in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of a composition as claimed in claim 33 .

36. The method as claimed in claim 35 , wherein the neurological condition is epilepsy.

37. The method as claimed in claim 36 , wherein the type of epilepsy is generalised seizure.

38. The method as claimed in claim 35 , further comprising administering to the subject a standard anti-epileptic drug (SAED).

39. The method for treating a neurological condition that involves hyper-excitability of the central nervous system, convulsions or seizures in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of a composition as claimed in claim 34 .

40. The method as claimed in claim 39 , wherein the neurological condition is epilepsy.

41. The method as claimed in claim 40 , wherein the type of epilepsy is generalised seizure.

42. The method as claimed in claim 39 , further comprising administering to the subject a standard anti-epileptic drug (SAED).

Assignments (5)
CHANGE OF NAME Recorded May 13, 2025
From: GW PHARMA LIMITED
To: JAZZ PHARMACEUTICALS OPERATIONS UK LIMITED
Reel/Frame 071103/0420 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 12, 2023
From: OTSUKA PHARMACEUTICAL CO., LTD.
To: GW PHARMA LTD.
Reel/Frame 063631/0588 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 18, 2021
From: WHALLEY, BENJAMIN; WILLIAMS, CLAIRE; STEPHENS, GARY
To: GW PHARMA LIMITED; OTSUKA PHARMACEUTICAL CO., LIMITED
Reel/Frame 057219/0610 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 18, 2021
From: HILL, THOMAS
To: GW PHARMA LIMITED; OTSUKA PHARMACEUTICAL CO., LIMITED
Reel/Frame 057219/0632 →
SECURITY AGREEMENT Recorded Jul 22, 2021
From: GW PHARMA LIMITED; GW RESEARCH LIMITED
To: U.S. BANK NATIONAL ASSOCIATION
Reel/Frame 056958/0493 →