人用药品欧洲公共评估报告（EPAR）：Ontozry，cenobamate，授权日期：2021年3月26日，修订版：12，状态：已获授权

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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. Application under evaluation European Commission decision 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. EMEA-002563-PIP02-19-M03 – paediatric investigation plan Ontozry – direct healthcare professional communication (DHPC) 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: English (EN) (117.31 KB – PDF) English (EN) (1.25 MB – PDF) English (EN) (748.03 KB – PDF) summary of product characteristics (annex I);

manufacturing authorisation holder responsible for batch release (annex IIA); conditions of the marketing authorisation (annex IIB);

package leaflet (annex IIIB). English (EN) (56.34 KB – PDF) 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. Angelini Pharma S. p. AViale Amelia 70,00181Rome – Italy Ontozry: EPAR – Medicine overview Ontozry: EPAR – Risk-management-plan Ontozry: EPAR – Product information Ontozry: EPAR – All authorised presentations 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.