Cenobamate: A Review in Focal-Onset Seizures

Area of Science:

• Neurology
• Pharmacology
• Epilepsy Research

Background:

• Epilepsy affects millions globally, with many adults experiencing focal-onset seizures inadequately controlled by existing treatments.
• Cenobamate (Ontozry®) is an oral antiseizure medication (ASM) approved for adjunctive therapy in the EU.
• Refractory epilepsy poses significant challenges, necessitating novel therapeutic options.

Purpose of the Study:

• To evaluate the efficacy and tolerability of cenobamate as an adjunctive treatment for adults with focal-onset seizures.
• To assess the long-term effectiveness and safety profile of cenobamate.
• To compare real-world data with clinical trial findings.

Main Methods:

• Analysis of clinical trial data assessing seizure frequency reduction and seizure freedom rates.
• Evaluation of treatment-emergent adverse events (TEAEs) during short-term and long-term treatment periods.
• Review of real-world evidence to confirm clinical trial outcomes.

Main Results:

• Short-term use of cenobamate significantly reduced seizure frequency and increased the likelihood of achieving ≥50% reduction in adults with uncontrolled focal-onset seizures.
• Seizure freedom rates improved with cenobamate treatment.
• Benefits were sustained up to 48 months, with overall tolerability demonstrated over 94 months. Common TEAEs included somnolence, dizziness, and fatigue.
• Real-world study findings were consistent with clinical trial data.

Conclusions:

• Cenobamate is a valuable adjunctive treatment option for adults with inadequately controlled focal-onset seizures.
• The medication's efficacy and safety profile, including a favorable tolerability during titration, support its use.
• Sustained seizure control and acceptable adverse event profile make cenobamate a promising therapy for refractory epilepsy.