Ontozry Approved In EU For Refractory Epilepsy Treatment, Clinical Data Demonstrate Significant Efficacy

The European Medicines Agency (EMA) recently approved Ontozry (cenobamato) for the treatment of refractory focal epileptic seizures in adults, providing a new therapeutic option for patients who have not responded well to traditional antiepileptic medications.

Ontozry is a novel antiepileptic drug that has attracted attention in the field of neurology because of its unique mechanism and high response rate in clinical trials.

In this article, we present Ontozry’s pharmacological properties, clinical data, safety, and market prospects.

Pharmacologic Mechanism And Indications Of Ontozry

The main active ingredient of Ontozry is cenobamato, which belongs to a new generation of antiepileptic drugs, and its mechanism of action includes:

Enhancement of GABAergic neurotransmission: inhibits neuronal hyperexcitability by modulating gamma-aminobutyric acid (GABA) receptors.

Inhibition of voltage-gated sodium channels reduces the spread of abnormal electrical activity, thereby reducing seizure frequency.

This drug is indicated for adults with refractory focal epilepsy (with or without secondary generalised seizures), especially in patients who have responded poorly to at least two conventional antiepileptic drugs (e.g., carbamazepine, sodium valproate).

Key Clinical Data: Significant Reduction In Seizure Frequency

The approval of Ontozry was based on several Phase III clinical trials, among others:
A pivotal study showed that 28% of patients treated with Ontozry achieved zero seizures compared to 9% in the placebo group.

The proportion of patients with a ≥50% reduction in median seizure frequency was 56%, significantly higher than in the control group (22%).

Long-term extension trials showed that efficacy could be sustained for at least 3 years and was well tolerated.
These data make it an important complementary treatment option for patients with refractory epilepsy.

Safety and Common Adverse Reactions

Despite Ontozry’s efficacy, safety concerns remain:
Common side effects: drowsiness, fatigue, dizziness, and gastrointestinal discomfort (e.g., nausea).

Serious risks:
Shortened QT interval: contraindicated in patients with congenital short QT syndrome.
Risk of Suicidal Tendencies: similar to other antiepileptic drugs, monitor patients for mood changes.

Drug Interactions: may potentiate the effects of other CNS depressants (e.g., benzodiazepines, alcohol); dose adjustment required.

European regulators recommend gradual dose adjustments to minimise adverse effects and regular monitoring of electrocardiograms (ECGS).

Market Outlook And Accessibility

Ontozry is manufactured by Angelini Pharma and is currently marketed in Europe as film-coated tablets (12.5 mg to 200 mg).

Due to patent protection, it will not face generic competition in the short term, but parallel import policies may affect its pricing strategy.

Price differences: Some EU countries (e.g. Greece) may have lower selling prices than the Nordic market, prompting parallel trade.

Patient support programs: Some countries provide subsidies for special medications to reduce the financial burden of long-term treatment.

Conclusion

The approval of Ontozry brings new hope to patients with refractory epilepsy, and its unique dual mechanism of action and significant clinical efficacy make it an important addition to antiepileptic therapy.

However, physicians and patients need to weigh its efficacy against potential risks and follow the principle of individualised dosing.

With the accumulation of more clinical data, Ontozry is expected to further strengthen its position in the field of epilepsy treatment.

However, DengYue’s efforts to increase the affordability of the medicine are critical to ensuring that more patients benefit from it.

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Information from DengYueMed, China Drug Import and Export Wholesaler, offers this information as a guide, not a substitute for professional medical advice. Consult your doctor before any treatment.