Drug updated on 4/10/2024
| Dosage Form | Tablet (oral; 10 mg, 20 mg); suspension (oral; 2.5 mg/mL) |
| Drug Class | Benzodiazepines |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- For the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.
Summary
- Clobazam (Onfi) is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older. This medication has shown significant efficacy, particularly at high doses, resulting in a reduction in drop-seizures over the long term.
- Eight systematic reviews and meta-analyses were analyzed to determine information about Onfi's safety profile and effectiveness. These studies highlighted potential adverse reactions such as severe skin reactions, respiratory infections/inflammations, central sedation, and possible interactions with other antiepileptic drugs.
- Compared to cannabidiol (CBD), clobazam was found to have fewer adverse events like diarrhea, somnolence, and sedation. However, when used alongside CBD, there was an increased incidence of these side effects.
- In terms of effectiveness compared to other antiseizure medications including felbamate and lamotrigine for LGS treatment, high-dose clobazam along with CBD were among the most effective options according to a systematic review on comparative effectiveness.
- A Cochrane review suggested that while add-on lamotrigine showed evidence for overall seizure reduction, it ranked below clobazam, which demonstrated its own effectiveness, especially in focal-onset seizures, despite very low-quality evidence supporting this claim, indicating the need for further research into this area.
- The population types considered included children aged 2 years old up through adults suffering from LGS, which often starts during childhood. Subgroup considerations focused on comorbidity factors such as the interaction between clobazam with other medications, notably CBD, impacting both therapeutic efficiency and safety profiles, requiring careful consideration based on individual patient needs.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Onfi (clobazam) Prescribing Information. | 2024 | Lundbeck, Deerfield, IL |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| An Italian consensus on the management of Lennox-Gastaut syndrome. | 2022 | Seizure: European Journal of Epilepsy |
| Cannabidiol for the treatment of Lennox-Gastaut syndrome and Dravet syndrome: Expert recommendations on its use in clinical practice in Spain. | 2021 | Neurologia |
| Expert opinion: Proposed diagnostic and treatment algorithms for Lennox–Gastaut syndrome in adult patients. | 2020 | Epilepsy & Behavior |
| An evaluation of clobazam tablets and film (AQST-120) for the treatment of Lennox-Gastaut syndrome. | 2019 | Expert Opinion on Pharmacotherapy |