Basic Information
N03AX
其它抗癫痫药
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.
Overview Summary
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.
Active Substances (1)
cenobamate
Documents (12)
Ontozry : EPAR - Public assessment report
April 13, 2021
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Ontozry : EPAR - Risk-management-plan
April 13, 2021
RISK_MANAGEMENT_PLAN_SUMMARY
Ontozry : EPAR - Procedural steps taken and scientific information after authorisation
June 2, 2021
CHANGES_SINCE_INITIAL_AUTHORISATION
Ontozry : EPAR - Product information
April 13, 2021
DRUG_PRODUCT_INFORMATION
Ontozry-H-C-PSUSA-00010921-202303 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
January 17, 2024
CHANGES_SINCE_INITIAL_AUTHORISATION
CHMP summary of positive opinion for Ontozry
February 1, 2021
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Ontozry : EPAR - All authorised presentations
April 13, 2021
AUTHORISED_PRESENTATIONS
Ontozry : EPAR - Medicine overview
April 13, 2021
OVERVIEW_DOCUMENT
Ontozry : EPAR - Procedural steps taken and scientific information after authorisation
April 8, 2025
CHANGES_SINCE_INITIAL_AUTHORISATION
Ontozry : EPAR - Procedural steps taken and scientific information after authorisation (archive)
June 2, 2021
CHANGES_SINCE_INITIAL_AUTHORISATION
Ontozry : EPAR - Public assessment report
April 13, 2021
CHANGES_SINCE_INITIAL_AUTHORISATION
CHMP summary of positive opinion for Ontozry
February 1, 2021
CHANGES_SINCE_INITIAL_AUTHORISATION
Overview Q&A (7)
Question
Other information about Ontozry
Answer
Ontozry received a marketing authorisation valid throughout the EU on 26 March 2021.
Question
How is Ontozry used?
Answer
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.
Question
How does Ontozry work?
Answer
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.
Question
What benefits of Ontozry have been shown in studies?
Answer
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.
Question
What are the risks associated with Ontozry?
Answer
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.
Question
Why is Ontozry authorised in the EU?
Answer
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.
Question
What measures are being taken to ensure the safe and effective use of Ontozry?
Answer
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.