Gw Pharma Limited

Gw Research Limited

Jazz Pharmaceuticals Research UK Limited

Otsuka Pharmaceutical Company, Limited

Geoffrey W Guy

Stephen Wright

Orrin Devinsky

Alice Mead

Volker Knappertz

Marie Woolley-Roberts

Benjamin Whalley

Brian Anthony Whittle

Tetsuro Kikuchi

James Brodie

Colin Stott

Daniela Parolaro

Livio Luongo

Alan Sutton

Philip Robson

Vincenzo Di Marzo

David W Pate

Royston Gray

Rafael Maldonado

David Victor Downs

Rohini Rajyalaxmi Rana

Elizabeth Thiele

David Critchley

Eduardo Dunayevich

Martin Philip Riddiford

Claire Williams

Gary Stephens

Luciano De Petrocellis

Angelo Antonio Izzo

Sofia Torres

Etienne De Meijer

Mar Lorente

Guillermo Velasco

Manuel Guzman

Paola Massi

Sharon Anavi-Goffer

David Potter

Roger Pertwee

Bettina Platt

Matthew James Grey

Ruth Alexandra Ross

Alessia Ligresti

Aniello Schiano Moriello

Gabriella Aviello

Katarzyna Lach-Falcone

Angus Wilfong

Charuta Joshi

Lesley Ann Ford

Kenji Maeda

Rajiv Bobby Dave

Ben Whalley

Anne Comi

Francesca Borrelli

Dominic Schiller

Joanna Neill

Barbara Costa

Emma Cheetham

Sabatino Maione

Francesca Borelli

Teresa Iuvone

Jose Martinez-Orgado

Francesco Rossi

Harpreet Singh

Joanna Jamontt

David c/o Gw Pharmaceuticals Plc Downs

The present disclosure relates to the use of cannabidiol (CBD) for the treatment of atonic seizures. In particular the CBD appears particularly effective in reducing atonic seizures in patients suffering with etiologies that include: Lennox-Gastaut Syndrome; Tuberous Sclerosis Complex; Dravet Syndrome; Doose Syndrome; Aicardi syndrome; CDKL5 and Dup15q in comparison to other seizure types. The disclosure further relates to the use of CBD in combination with one or more anti-epileptic drugs (AEDs).

Use of cannabinoids in the treatment of epilepsy

The present invention relates to a cannabidiol (CBD) type cannabinoid compound for use as a medicament. The CBD-type cannabinoid, cannabidiol-C1 (CBD-C1), is a naturally occurring cannabinoid that can be found in minor quantities in theplant. Furthermore, the 5 cannabinoid can be produced by synthetic means and a method for the production of CBD-C1 is described herein. In addition, disclosed herein are data which demonstrate the efficacy of CBD-C1 in models of disease.

Cannabidiol-type cannabinoid compound

The present invention relates to a cannabidiol (CBD) type cannabinoid compound for use as a medicament. The CBD-type cannabinoid, 6-hydroxy cannabidiol (6-0 H CBD), is a metabolite of CBD. The cannabinoid can be produced by synthetic means and a method for the production of 6-0 H CBD is described herein. In addition, disclosed herein are data which demonstrate the efficacy of 6-0 H CBD in a model of disease.

The present invention relates to the use of cannabidiol (CBD) in the treatment of patients with childhood-onset epilepsy who are concurrently taking immunosuppressant drugs. In particular the immunosuppressant drug is a calcineurin inhibitor. More particularly the immunosuppressant drug is tacrolimus. Where the CBD is used in combination with an immunosuppressant drug, caution should be taken. For example, the dose of either the CBD and/or the immunosuppressant drug may be required to be reduced. Moreover, the patient may need to be monitored for side effects of said drug-drug interaction. Preferably the CBD used is in the form of a highly purified extract of cannabis such that the CBD is present at greater than 98% of the total extract (w/w) and the other components of the extract are characterised. In particular the cannabinoid tetrahydrocannabinol (THC) has been substantially removed, to a level of not more than 0.15% (w/w) and the propyl analogue of CBD, cannabidivarin, (CBDV) is present in amounts of up to 1%. Alternatively, the CBD may be a synthetically produced CBD.

The present invention relates to a cannabidiol (CBD) type cannabinoid compound for use as a medicament. The CBD-type cannabinoid, cannabidiol-C6 (CBD-C6), is a naturally occurring cannabinoid that can be found in minor quantities in the cannabis plant. Furthermore, the cannabinoid can be produced by synthetic means and a method for the production of CBD-C6 is described herein. In addition, disclosed herein are data which demonstrate the efficacy of CBD-C6 in models of disease.

The present invention relates to the use of cannabidiolic acid (CBDA) in the treatment of autism spectrum disorder (ASD) and ASD-associated disorders, such as Fragile X syndrome (FXS); Rett syndrome (RS); or Angelman syndrome (AS). CBDA has been shown to be particularly effective in improving cognitive dysfunction in rodent models of ASD, FXS, RS and AS. The CBDA is preferably substantially pure. It may take the form of a highly purified extract ofsuch that the CBDA is present at greater than 95% of the total extract (w/w) and the other components of the extract are characterised. Alternatively, the CBDA is synthetically produced.

Use of cannabidiolic acid in the treatment of autism spectrum disorder and associated disorders

The present disclosure provides methods of treating tuberous sclerosis complex comprising administering cannabidiol and everolimus.

Methods of treating tuberous sclerosis complex with cannabidiol and everolimus

The present invention relates to the use of cannabidiol (CBD) in the treatment of focal seizures. In one embodiment the patients suffering from focal seizures are children and young adults. CBD appears particularly effective in reducing focal seizures in patients suffering with etiologies that include: Lennox-Gastaut Syndrome; Tuberous Sclerosis Complex; Dravet Syndrome; CDKL5; Neuronal ceroid lipofuscinoses (NCL); febrile infection related epilepsy syndrome (FIRES); Aicardi syndrome and brain abnormalities in comparison to other seizure types. Significantly CBD additionally is very effective in the reduction of a sub-type of focal seizures, focal seizures with impairment.

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).

Cannabidiol (CBD) is a cannabinoid designated chemically as 2-[(IR,6R)-3-Methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl]-5-pentyl-1,3-benzenediol. Its empirical formula is CHOand its molecular weight is 314.46. CBD is a cannabinoid that naturally occurs in theL. plant. CBD is a white to pale yellow crystalline solid which is insoluble in water and soluble in organic solvents. The present invention encompasses the surprising recognition that certain CBD preparations which are prepared from a botanical origin are more effective in treating diseases or disorders than preparations of CBD which are synthetic or purified to the extent no other impurities in the form of other cannabinoids are present. Prior CBD compositions have been prepared such that no psychoactive components, e.g., tetrahydrocannabinol (THC), remain in the final CBD preparation. Surprisingly, the absence of such minor impurities reduces the efficacy of CBD treatment. Such CBD preparations are characterized by chemical components and/or functional properties that distinguish them from prior CBD compositions. One or more components of the preparations described herein provide an unexpectedly synergistic effect when utilized in combination.

Cannabidiol preparations and its uses

The present invention relates to the use of cannabidivarin (CBDV) in the treatment of autism spectrum disorder (ASD) and ASD-associated disorders such as Fragile X syndrome (FXS); Rett syndrome (RS); or Angelman syndrome (AS). In a further embodiment the invention relates to the use of CBDV in the treatment of schizophrenia. CBDV has been shown to be particularly effective in improving cognitive dysfunction in rodent models of ASD, FXS, RS, AS and schizophrenia. The CBDV is preferably substantially pure. It may take the form of a highly purified extract ofsuch that the CBDV is present at greater than 95% of the total extract (w/w) and the other components of the extract are characterised. Alternatively, the CBDV is synthetically produced.

Use of cannabidivarin in the treatment of autism spectrum disorder, associated disorders and schizophrenia

The present invention relates to the use of cannabidiol (CBD) in the treatment of Angelman syndrome (AS). CBD has been shown to be particularly effective in improving anxiety in rodent models of AS. The CBD is preferably substantially pure. It may take the form of a highly purified extract ofsuch that the CBD is present at greater than 98% of the total extract (w/w) and the other components of the extract are characterised. Alternatively, the CBD is synthetically produced. Alternatively, the CBD may be used as a botanical drug substance (BDS) from aplant in which CBD is the predominant cannabinoid. The CBD may also be present in combination with other cannabinoids and non-cannabinoid components such as terpenes. In use the CBD may be used concomitantly with one or more other medicaments. Alternatively, the CBD may be formulated for administration separately, sequentially or simultaneously with one or more medicaments or the combination may be provided in a single dosage form. Where the CBD is formulated for administration separately, sequentially or simultaneously it may be provided as a kit or together with instructions to administer the one or more components in the manner indicated. It may also be used as the sole medication, i.e. as a monotherapy.

Use of cannabinoids in the treatment of Angelman syndrome

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Piddletrenthide, United Kingdom

Geoffrey W Guy