USE OF CANNABINOIDS IN COMBINATION WITH AN ANTI-PSYCHOTIC MEDICAMENT

• US 20110038958A1
• Filed: 12/17/2008
• Published: 02/17/2011
• Est. Priority Date: 01/04/2008
• Status: Active Grant

• Current Assignee: GW Pharmaceuticals Limited (Jazz Pharmaceuticals Plc)
• Original Assignee: GW Pharmaceuticals Limited (Jazz Pharmaceuticals Plc), Otsuka Pharmaceutical Company Limited (Otsuka Holdings Company Limited)
• Inventors: Maeda, Kenji, Kikuchi, Tetsuro, Robson, Philip, Stott, Colin, Guy, Geoffrey
• Granted Patent: US 9,017,737 B2
• Time in Patent Office: Days
• US Class Current: 424/725
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/05 Phenols cannabinoids A61K31/658
• CPC Class Codes: A61K 31/35 having six-membered rings with one oxygen as the only ring hetero atom
• CPC Class Codes: A61K 31/352 condensed with carbocyclic rings, e.g. methantheline cannabinoids A61K31/658
• CPC Class Codes: A61K 36/185 Magnoliopsida (dicotyledons)
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 21/00 Drugs for disorders of the muscular or neuromuscular system
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/08 Antiepileptics; Anticonvulsants
• CPC Class Codes: A61P 25/18 Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
• CPC Class Codes: A61P 25/22 Anxiolytics
• CPC Class Codes: A61P 25/24 Antidepressants
• CPC Class Codes: A61P 27/02 Ophthalmic agents
• CPC Class Codes: A61P 3/04 Anorexiants; Antiobesity agents
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

The present invention relates to the use of one or more cannabinoids in combination with one or more anti-psychotic medicaments for use in the prevention or treatment of psychosis and psychotic disorders. Preferably the one or more cannabinoids are taken from the group: cannabidiol (CBD); cannabidiolic acid (CBDA); tetrahydrocannbidivarin (THCV); tetrahydrocannbidivarinin acid (THCVA); cannabichromene (CBC); cannabichromenic acid (CBCA); cannabigerol (CBG) and cannabigerolic acid (CBGA). Preferably the anti-psychotic medication is an atypical anti-psychotic medication.

Claims

1-14. -14. (canceled)

15. A method for the treatment or prevention of psychosis or a psychotic disorder, which comprises administering to a subject in need thereof a therapeutically effective amount of one or more phyto-cannabinoids selected from the group consisting of THCV and/or CBD, with an atypical anti-psychotic medicament, wherein the one or more cannabinoids are administered separately, sequentially or simultaneously to the atypical anti-psychotic medicament so as to reduce or remove undesirable side effects of the atypical anti-psychotic medicament and/or provide additional anti-psychotic effects.

18. The method as claimed in claim 15, wherein the undesirable side effects that are reduced or removed are selected from the group consisting of:

obesity;

catalepsy; and

ptosis.

19. The method as claimed in claim 15, wherein the additional anti-psychotic effects take a sub-effective dose of the atypical anti-psychotic medicament to an effective dose level.

20. The method as claimed in claim 15, wherein one or more phyto-cannabinoids are present in the form of a cannabis plant extract, which depending on the composition of the extract, has all or a proportion of THC or THCA selectively removed.

21. The method as claimed in claim 15, wherein the one or more phyto-cannabinoids are in the form of a botanical drug substance.

22. The method as claimed in claim 21, wherein the botanical drug substance comprises all the naturally occurring phyto-cannabinoids in the plant.

23. The method as claimed in claim 15, wherein the one or more phyto-cannabinoids are in a substantially pure form.

24. The method as claimed in claim 15, wherein the one or more phyto-cannabinoids are in an isolated form.

25. The method as claimed in claim 15, wherein the one or more phyto-cannabinoids are in a synthetic form.

26. The method as claimed in claim 15, wherein the one or more phyto-cannabinoids are combined with the atypical anti-psychotic medicament and formulated as a pharmaceutical composition further comprising one or more pharmaceutically acceptable carriers, excipients or diluents.

27. The method as claimed in claim 15, wherein the atypical anti-psychotic medicament is taken from the group:

aripiprazole;

risperidone;

paliperidone;

ziprasidone;

olanzapine;

quetiapine;

clozapine;

sulpiride;

amisulpride;

iloperidone;

cariprazine; and

asenapine.

28. The method as claimed in claim 27, wherein the atypical anti-psychotic medicament is aripiprazole.

29. The method as claimed in claim 15, wherein the psychosis or psychotic disorder to be treated is taken from the group:

schizophrenia;

schizophreniform disorder (acute schizophrenic episode);

schizoaffective disorder;

bipolar I disorder (mania, manic disorder, manic-depressive psychosis);

bipolar II disorder;

major depressive disorder with psychotic feature (psychotic depression);

delusional disorders (paranoia);

Shared Psychotic Disorder (Shared paranoia disorder);

Brief Psychotic disorder (Other and Unspecified Reactive Psychosis);

Psychotic disorder not otherwise specified (Unspecified Psychosis);

paranoid personality disorder;

schizoid personality disorder; and

schizotypal personality disorder.

16. A method for the treatment or prevention of psychosis or a psychotic disorder in a child or juvenile, which comprises administering to a subject in need thereof a therapeutically effective amount of one or more phyto-cannabinoids selected from the group consisting of THCV and/or CBD, in combination with an atypical anti-psychotic medicament, wherein the one or more phyto-cannabinoids are administered separately, sequentially or simultaneously to the atypical anti-psychotic medicament so as to reduce or remove undesirable side effects of the atypical anti-psychotic medicament and/or provide additional anti-psychotic effects.

17. A pharmaceutical formulation for use in the prevention or treatment of psychosis or a psychotic disorder, which comprises one or more phyto-cannabinoids selected from the group consisting of THCV and/or CBD, and an atypical anti-psychotic medicament, for administration separately, sequentially or simultaneously so as to reduce or remove undesirable side effects of the atypical anti-psychotic medicament and/or provide additional anti-psychotic effects.