Drug updated on 9/4/2024
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.
Latest News
Summary
- Onfi (clobazam) is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.
- This summary is based on the review of eight systematic review(s)/meta-analysis(es). [1-8]
- Cannabidiol (CBD) showed significant effectiveness in reducing seizure frequency in patients with Dravet syndrome (DS), Lennox-Gastaut syndrome (LGS), and tuberous sclerosis complex (TSC), with enhanced efficacy when used in combination with clobazam.
- High-dose clobazam (CLB_H) was significantly associated with a ≥50% reduction in drop seizure frequency and had the highest efficacy ranking among antiepileptic drugs (AEDs) in both short-term and long-term outcomes.
- Clobazam did not demonstrate significant differences compared to other AEDs in overall seizure cessation or reduction according to high-certainty evidence.
- Common adverse drug reactions (ADRs) included nervous system disorders, severe skin reactions, respiratory infections, and one death due to aspiration pneumonia. Significant concerns included severe skin reactions, respiratory infections/inflammations, central sedation, and interactions with CYP3A4 or CYP2C19 inhibitors.
- High-certainty evidence indicated a high rate of adverse events leading to study discontinuation with add-on clobazam and other ASMs.
- Patients on clobazam in combination with CBD experienced increased incidences of somnolence, sedation, and elevated transaminases.
- Clobazam was associated with adverse events such as drowsiness, and there was a slightly higher incidence of treatment discontinuation due to adverse events.
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 |
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 |