Drug updated on 12/11/2024
Dosage Form | Solution (oral; 100 mg/mL) |
Drug Class | Cannabinoids |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or Tuberous sclerosis complex in patients 1 year of age and older.
Latest News
Summary
- This summary is based on the review of 21 systematic review(s)/meta-analysis(es). [1-21]
- Seizure Reduction in Dravet Syndrome (DS): Cannabidiol (CBD) reduced seizure frequency by 33%, with a 20% increase in the number of patients achieving a ≥50% reduction in seizures and a 3% increase in seizure freedom. However, CBD was less effective than stiripentol, fenfluramine, and soticlestat in reducing seizure frequency by ≥50%.
- Seizure Reduction in Lennox-Gastaut Syndrome (LGS): High-dose CBD significantly reduced drop seizure frequency in patients with LGS and drug-resistant epilepsy, showing a ≥50% reduction in seizure frequency compared to placebo. CBD was effective in LGS both with and without concomitant clobazam (CLB).
- Seizure Reduction in Other Conditions: CBD demonstrated effectiveness in reducing seizures in patients with tuberous sclerosis complex (TSC) and pediatric epilepsy. It also showed therapeutic benefits for epilepsy and Parkinsonism.
- Comparative Effectiveness: Stiripentol, fenfluramine, and soticlestat were more effective than CBD in reducing convulsive seizures in DS, with higher seizure response rates and a greater probability of achieving a ≥50% reduction in seizure frequency.
- CBD was associated with an increase in adverse events (AEs) by 12%, serious AEs by 16%, and a 15% increase in transaminase elevations, particularly in patients using concomitant valproate. Common AEs included somnolence and sedation, especially when used with CLB.
- CBD had a lower proportion of participants experiencing AEs compared to fenfluramine, but a higher risk of AEs than stiripentol. High-dose CBD had significantly higher odds of treatment-emergent adverse events (TEAEs) compared to placebo.
- Adverse events specific to CBD use included decreased appetite, rash, pneumonia, and aggression, with higher incidences of somnolence and sedation reported in patients taking CBD with CLB.
- CBD has demonstrated effectiveness in reducing seizures in pediatric patients with DS, children and adults with LGS, and patients with tuberous sclerosis complex (TSC) and drug-resistant epilepsy. In subgroups, CBD's efficacy was observed both with and without concomitant CLB, with notable differences in safety profiles when used alongside CLB, particularly higher rates of somnolence and sedation.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Epidiolex (cannabidiol) Prescribing Information. | 2024 | Jazz Pharmaceuticals, Inc., Palo Alto, CA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Medical cannabis for children: Evidence and recommendations. | 2024 | Paediatrics & Child Health |
Consensus panel recommendations for the optimization of EPIDIOLEX® treatment for seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex | 2024 | Epilepsia Open |
A practical guide to the treatment of dravet syndrome with anti-seizure medication. | 2022 | CNS Drugs |
Guidance on the use of cannabis-based products for medicinal use in children and young people with epilepsy. | 2021 | British Paediatric Neurology Association |
Pharmacological treatment of central neuropathic pain: consensus of the Brazilian Academy of Neurology | 2020 | Arquivos de Neuro-Psiquiatria |
Epilepsy and cannabidiol: a guide to treatment. | 2020 | Epileptic Disorders |
National Institute for Health and Care Excellence (NICE) guidelines on cannabis-based medicinal products: clinical practice implications for epilepsy management. | 2020 | European Medical Journal |