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EPIDYOLEX® is the only regulatory approved prescription CBD anti-seizure medication, which means that it has a safety and efficacy profile that has been thoroughly evaluated in clinical trials. It also means that this plant-based, never synthetic, highly purified form of CBD is manufactured to meet the high standards of Good Manufacturing Practices and the World Health Organization's Good Agricultural Practices.

WHAT IS EPIDYOLEX® (CBD)?

CBD is one of the main cannabinoids present in the Cannabis sativa plant and can often be confused with the other main cannabinoid in cannabis, tetrahydrocannabinol (THC). Despite their similarities, these two cannabinoids have very different effects. THC is primarily responsible for the euphoric effects of cannabis, whereas CBD has been associated with anticonvulsant and neuroprotective effects.12

WHAT IS EPIDYOLEX® (CBD)?

HOW EPIDYOLEX® WORKS

  • Structurally distinct from other ASMs3
  • Reduces neuronal hyperexcitability through multiple mechanisms of action1
  • Does not exert its anticonvulsant effects through interaction with cannabinoid receptors1
Reduction of neuronal hyperexcitability via 3 main actions (theoretical):1,11
how_epidy_works_video

  • 1

    GPR55

    (G-protein coupled receptor 55) Antagonises G-protein coupled receptor 55 (GPR55) modulating intracellular calcium1,11

  • 2

    TRPV1

    (Transient receptor potential vanilloid 1) Desensitises TRPV1 channels modulating intracellular calcium1,11

  • 3

    ENT1

    (Equilabrative nucleoside transporter 1) Inhibits adenosine intracellular uptake via ENT1 increasing extracellular adenosine1,11

1

GPR55

(G-protein coupled receptor 55) 
Antagonises G-protein coupled receptor 55 
(GPR55) modulating intracellular calcium1,11

2

TRPV1

(Transient receptor potential vanilloid 1) 
Desensitises TRPV1 channels modulating 
intracellular calcium1,11

3

ENT1

(Equilabrative nucleoside transporter 1) 
Inhibits adenosine intracellular uptake via ENT1 
increasing extracellular adenosine1,11

EPIDYOLEX® HAS AN ALTERNATIVE MECHANISM OF ACTION

That provides a different way to treat seizures vs. conventional ASMs 1,11

NO EUPHORIC EFFECTS

The euphoric effects of cannabis are mediated through cannabinoid type 1 (CB1) receptors which are mostly located in the brain. Whilst CBD and THC are structurally very similar, they work via different mechanisms in the body. CBD has limited CB1 binding ability and therefore no euphoric effects.12

Growing and manufacturing

HOW IS EPIDYOLEX® PRODUCED?

EPIDYOLEX® is produced in the UK at our industry-leading growing and manufacturing facilities.

Jazz Pharmaceuticals control the entire process start-to-end, from selectively breeding and growing all plants according to Good Agricultural Practice, to extraction and purification according to GxP standards, through to accurate product labelling and secure shipping. This ensures batch-to-batch consistency for all patients, so you can prescribe with confidence.

The 6 stages of production

stages of production
The 6 stages of production mobile

HOW TO START

TREATMENT WITH EPIDYOLEX®

EPIDYOLEX® is a valuable option for your treatment strategy that can help you address the complexity of LGS, DS and TSC management. Long-term tolerability and been demonstrated as consistent in LGS, DS and TSC.

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ABOUT THE EFFICACY OF EPIDYOLEX®

EPIDYOLEX® has been assessed in 5 Phase III clinical trials within Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS) and Tuberous Sclerosis Complex (TSC) including 938 patients and 3 open-label extension studies.

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EFFICACY BEYOND SEIZURES

BECOME is a global outcomes survey of caregivers of 498 people with LGS or DS that assessed changes in behaviour, cognition and more with EPIDYOLEX® after ≥3 months of treatment, compared to the month prior to initiation.

Uncover the study

ABBREVIATIONS

ASM: anti-seizure medication; CB1: Cannabinoid Receptor 1; CBD: cannabidiol; DS: Dravet syndrome; GxP: Good Practice; LGS: Lennox-Gastaut syndrome; THC: tetrahydrocannabinol; TSC: tuberous sclerosis complex.

* Clobazam currently does not have marketing authorisation in Norway.

† The Decision Forum Nye Metoder has determined that treatment with EPIDYOLEX® must be initiated by a neurologist or paediatrician, who has experience in treating patients with LGS, DS or TSC.

  1. EPIDYOLEX® Summary of Product Characteristics. Approved: May 2023.
  2. Raga S, et al. Epileptic Disord. 2021;23(1):40–52.
  3. Marchese F, et al. SN Compr Clin Med. 2021;3:2167–2179.
  4. Patel AD, et al. Epilepsia. 2021;62(9):2228–2239.
  5. Scheffer IE, et al. Epilepsia. 2021;62(10):2505–2517.
  6. Thiele EA, et al. Epilepsia. 2022;63(2):426–439.
  7. Berg A, et al. Epilepsy Research. 2023;107280:0920-1211.
  8. Privitera M, et al. Epilepsia. 2021;62:1130–1140.
  9. Cohen JM, et al. Epilepsia. 2021;62:2218–2227.
  10. Thiele EA, et al. Epilepsia. 2022;63(2):426–439.
  11. Gray, RA and Whalley, BJ. Epileptic Disorders. 2020;(S1)22:S10–S15.
  12. Billakota S, et al. Curr Opin Neurol. 2019;32(2):220–226.

REFERENCES

  1. EPIDYOLEX® Summary of Product Characteristics. Approved: May 2023.
  2. Raga S, et al. Epileptic Disord. 2021;23(1):40–52.
  3. Marchese F, et al. SN Compr Clin Med. 2021;3:2167–2179.
  4. Patel AD, et al. Epilepsia. 2021;62(9):2228–2239.
  5. Scheffer IE, et al. Epilepsia. 2021;62(10):2505–2517.
  6. Thiele EA, et al. Epilepsia. 2022;63(2):426–439.
  7. Berg A, et al. Epilepsy Research. 2023;107280:0920-1211.
  8. Privitera M, et al. Epilepsia. 2021;62:1130–1140.
  9. Cohen JM, et al. Epilepsia. 2021;62:2218–2227.
  10. Thiele EA, et al. Epilepsia. 2022;63(2):426–439.
  11. Gray, RA and Whalley, BJ. Epileptic Disorders. 2020;(S1)22:S10–S15.
  12. Billakota S, et al. Curr Opin Neurol. 2019;32(2):220–226.

ABBREVIATIONS

ASM: anti-seizure medication; CB1: Cannabinoid Receptor 1; CBD: cannabidiol; DS: Dravet syndrome; GxP: Good Practice; LGS: Lennox-Gastaut syndrome; THC: tetrahydrocannabinol; TSC: tuberous sclerosis complex.

FOOTNOTES

* Clobazam currently does not have marketing authorisation in Norway.

† The Decision Forum Nye Metoder has determined that treatment with EPIDYOLEX® must be initiated by a neurologist or paediatrician, who has experience in treating patients with LGS, DS or TSC.