The European Commission ( EC ) has approved Briviact ( Brivaracetam ) as an adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalization ( spreading to both sides of the brain after the initial seizure ) in adult and adolescent patients from 16 years of age with epilepsy.
Briviact treatment is initiated without titration, meaning patients receive a therapeutic dose of the drug from the first day of treatment.
The EC approval is based on pooled data from three pivotal phase 3 studies ( N01252, N01253 and N01358 ), in which Brivaracetam has demonstrated statistically significant reductions over placebo in partial-onset seizure frequency per 28 days ( 19.5%, 24.4% and 24.0% for Brivaracetam 50, 100 and 200 mg/day respectively, p less than 0.01 ).
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 ), versus 20.3% for placebo ( p less than 0.01 for all arms ).
Brivaracetam was generally well tolerated by patients, and the most commonly reported adverse reactions ( greater than or equal to 5% ) with the drug were somnolence ( 15.2% ), dizziness ( 11.2% ), headache ( 9.6% ) and fatigue ( 8.7% ).
Brivaracetam is a selective high-affinity synaptic vesicle protein 2A ligand available in three formulations ( film-coated tablets, oral solution and solution for injection / infusion ).
Briviact can be initiated without titration, meaning patients receive a therapeutic dose of Brivaracetam from the first day of treatment.
Physicians are also able to adjust dosing up or down depending on patient response and tolerability.
Epilepsy is a chronic neurological disorder affecting around 7 million people in Europe. Despite currently-available treatments, many patients with epilepsy still experience seizures regardless of using at least one AED.
Epilepsy is considered to be a disease of the brain defined by any of the following conditions: (1) at least two unprovoked ( or reflex ) seizures occurring more than 24 hours apart; (2) one unprovoked ( or reflex ) seizure and a probability of further seizures similar to the general recurrence risk ( at least 60% ) after two unprovoked seizures, occurring over the next 10 years; (3) diagnosis of an epilepsy syndrome. ( Xagena )
Source: UCB, 2016