CHANGING THEIR LIVES
by reducing seizure frequency in Lennox- Gastaut syndrome (LGS) and Dravet syndrome (DS)
The first and only regulatory-approved pharmaceutical CBD medicine in LGS and DS in Europe.1
Epidyolex is indicated for use as adjunctive therapy of seizures associated with LGS or DS, in conjunction with clobazam, for patients 2 years of age and older.1 Epidyolex has orphan designation for the treatment of LGS and DS.
Quality of life
Patients and caregivers of patients taking Epidyolex reported a significant improvement in overall condition on a Global Impression of Change scale compared to placebo.1
Proven sustained efficacy
Demonstrated seizure reduction and is generally well tolerated in large Phase III clinical trials, across a range of ages.1
Large clinical development programme
GW Pharmaceuticals has conducted a large clinical trial programme within LGS and DS, including 714 patients.1
Novel Mechanism of Action
The novel Mechanism of Action provides a new approach to treating seizures.1 The precise mechanism by which Epidyolex exerts its anticonvulsant effects in humans is unknown.
More than 20 years of research
Developed following more than 20 years of cannabinoid research and development by GW Pharmaceuticals.
UK manufacturing
Industry-leading facilities and process at GW Pharmaceuticals
Efficacy
Significant seizure reduction in controlled trials vs. placebo, which was sustained at 48 weeks in both LGS and DS1
Overall population is presented in-line with data provided in the Summary of Product Characteristics (SmPC). Epidyolex should only be prescribed as per the licensed indication. Epidyolex is indicated for use as adjunctive therapy of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS), in conjunction with clobazam, for patients 2 years of age and older.1
The recommended starting dose is 2.5 mg/kg twice daily. Based on individual clinical response and tolerability, if required this can increase in weekly increments of 2.5 mg/kg twice daily up to the maximum recommended dose of 20 mg/kg/day.1 Any dose increases above 10 mg/kg/day, up to the maximum recommended dose of 20 mg/kg/day, should be made considering individual benefit and risk and with adherence to the full monitoring schedule.1
Epidyolex is generally well tolerated
429 patients have been exposed to Epidyolex in Phase III controlled trials, as part of a large clinical trial programme within LGS and DS.1
Overall population is presented in-line with data provided in the SmPC. Epidyolex should only be prescribed as per the licensed indication.
Introducing Epidyolex in existing anti-epileptic drug (AED) regimens
Epidyolex can interact with some commonly prescribed AEDs, increasing the risk of specific adverse events:
| AED | Adverse events |
|---|---|
| Clobazam | Increased incidence of somnolence and transaminase elevations |
| Valproate | Increased incidence of transaminase elevations, diarrhoea and events of decreased appetite |
| Stiripentol | Minor decrease in CBD active metabolite and increase in stiripentol levels. Clinical importance has not been studied. Patients should be closely monitored for adverse drug reactions. |
| Phenytoin | Exposure to phenytoin may be increased when it is co-administered with cannabidiol. Assessed in vitro, not assessed in human clinical trials |
| Lamotrigine | Lamotrigine levels may be elevated when it is co-administered with cannabidiol. Assessed in vitro, not assessed in human clinical trials |
For more information about how to adjust dosage when co-administrating with other medications and recommended monitoring for patients taking Epidyolex, see dosing & monitoring.
The most common adverse events (≥10% patients) associated with Epidyolex are:1
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Decreased appetite
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Pyrexia
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Somnolence
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Diarrhoea
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Vomiting
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Fatigue
The most frequent cause of discontinuation was transaminase elevation.
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References
1. Epidyolex SmPC (Date accessed: 03/09/2020).