Overview

Ontozry is an epilepsy medicine for treating epileptic fits starting in one specific part of the brain (focal seizures), including those that eventually spread to the whole brain (secondary generalisation).

Ontozry is used as an add-on to other epilepsy medicines for adults with seizures that are not controlled despite having tried at least two other treatments.

It contains the active substance cenobamate.

Ontozry is available as tablets taken once daily. The patient starts with a daily dose of 12.5 mg and the dose increases over several weeks up to a target of 200 mg. If the patient’s seizures are still not controlled, the dose may increase to up 400 mg.

The medicine can only be obtained with a prescription. For more information about using Ontozry, see the package leaflet or contact your doctor or pharmacist.

Epilepsy is caused by abnormal electrical activity in the brain. The exact way in which Ontorzy works is unclear but it affects the activity of channels that allow electrical impulses to be transmitted between nerve cells. This may prevent abnormal electrical activity in the brain, reducing the chance of an epileptic fit.

In a main study involving 437 patients Ontorzy was more effective than placebo (a dummy treatment) at lowering the number of seizures in patients with uncontrolled partial seizures despite past treatment. Around 40% of patients who took a 100 mg daily dose of Ontorzy during 3 months of treatment and 64% of those who took a 400 mg daily dose had at least a 50% drop in the frequency of their seizures. This compares with 26% of patients taking placebo.

The most common side effects with Ontozry (which may affect more than 1 in 10 people) are sleepiness, headache and problems with keeping balance.

Ontozry should not be used by patients with familial short QT syndrome, a rare genetic condition that can lead to irregular heart rhythm. For the full list of restrictions and side effects, see the package leaflet.

A main study showed that Ontozry can reduce the frequency of seizures in many patients. The side effects that occur most frequently are those that affect the nervous system such as sleepiness, tiredness and dizziness.

The European Medicines Agency concluded that Ontozry’s benefits are greater than its risks and that it can be authorised for use in the EU.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ontozry have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Ontozry are continuously monitored. Side effects reported with Ontozry are carefully evaluated and any necessary action taken to protect patients.

Ontozry received a marketing authorisation valid throughout the EU on 26 March 2021.

Ontozry : EPAR - Medicine overview

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Ontozry : EPAR - Risk-management-plan summary

Product information

Ontozry : EPAR - Product information

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Latest procedure affecting product information: PSUSA/00010921/202303

12/01/2024

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This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

Ontozry : EPAR - All authorised presentations

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Product details

Name of medicine
Ontozry
Active substance
cenobamate
International non-proprietary name (INN) or common name
cenobamate
Therapeutic area (MeSH)
Epilepsy
Anatomical therapeutic chemical (ATC) code
N03AX

Pharmacotherapeutic group

Antiepileptics

Therapeutic indication

Adjunctive treatment of focal-onset seizures with or without secondary generalisation in adult patients with epilepsy who have not been adequately controlled despite a history of treatment with at least 2 anti-epileptic medicinal products.

Authorisation details

EMA product number
EMEA/H/C/005377

Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Marketing authorisation holder
Angelini Pharma S.p.A

Angelini Pharma S.p.A
Viale Amelia 70, 00181
Rome – Italy

Marketing authorisation issued
26/03/2021
Revision
6

Assessment history

Ontozry : EPAR - Procedural steps taken and scientific information after authorisation

Ontozry-H-C-PSUSA-00010921-202303 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Ontozry : EPAR - Public assessment report

CHMP summary of positive opinion for Ontozry

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