The HSE has accepted Briviact (brivaracetam) for use within Ireland as an add-on treatment for partial onset seizures (POS), with or without secondary generalised seizures in adults with epilepsy (aged 16 years and older).
The new medication provides patients with this particular type of epilepsy, an additional opportunity to better manage their seizures. Briviact use is restricted to patients with refractory epilepsy and treatment should be initiated by physicians who have appropriate experience in the treatment of epilepsy.
Briviact was developed by UCB and is already approved for use in several European countries following the European Medicines Agency (EMA) authorisation in January 2016.
In an international Phase 3 study of 768 patients uncontrolled on their previous medication, at 50mg dose twice daily against placebo, Briviact was shown to give significant seizure freedom compared with the patients' usual medication. The proportion of patients showing a >50% or greater reduction in partial-onset seizure frequency was 34.2% (50 mg/day), 39.5% (100 mg/day) and 37.8% (200 mg/day), compared to 20.3% for placebo. Studies found that the drug was generally well tolerated by patients, and the most commonly reported adverse events (≥5%) with the drug were drowsiness (15.2%), dizziness (11.2%), headache (9.6%) and fatigue (8.7%).
Briviact works by targeting a specific glycoprotein on pre-synaptic vesicles (fluid sacs) in the brain. It is thought that this prevents neurotransmitter release thereby stopping the signals responsible for seizures, but research is continuing to confirm this.
The twice-a-day medicine, available as a tablet, will cost the HSE €4.87 per day for 2 tablets at the recommended dose of 50mg.
Professor Norman Delanty, Director of the Epilepsy Programme at Beaumont Hospital said "It is estimated that over 37000 people in Ireland live with epilepsy, that's 1 in every 115 people. Unfortunately not every patient can achieve seizure freedom and for those whose seizures remain uncontrolled the impact on their quality of life cannot be overestimated. Patients need to be closely monitored when they have complex and uncontrolled epilepsy and an additional treatment that can potentially offer an improvement to their condition can have a great impact on their lives and the lives of their families. As an epilepsy specialist I welcome the arrival of a new drug into this disease area."
Peter Murphy, Chief Executive Officer of Epilepsy Ireland, also commented, "While the majority of people with epilepsy can become seizure free, as many as 10,000 – 15,000 people are still living with uncontrolled seizures. For this group in particular, the condition is a source of significant long-term, often hidden disability. Given the impact that refractory epilepsy can have on all aspects of a person's life, it's extremely important that patients can access the best possible treatments. It is always encouraging to see the approval of effective new epilepsy medications and Briviact will offer a new alternative for many people in Ireland who have so far struggled to achieve seizure freedom."
Partial-onset seizures (POS) specifically affect only part of the brain instead of both sides of the brain at once. Types of POS include Simple partial seizures and Complex partial seizures. Secondary generalised seizures occur when both sides of the brain are affected after the initial event (a partial seizure) has already begun. These seizures generally last 1 to 3 minutes and involve the stiffening of the muscles, loss of consciousness and rapid jerking.