Ontozry

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.