Positive Phase III Results Reported for Brivaracetam in Epilepsy Patients
New drug application expected early next year
Positive results have been reported from a phase III trial of brivaracetam (UCB) — a high-affinity synaptic vesicle protein 2A (SV2A) ligand — as adjunctive treatment in adult focal epilepsy patients with partial-onset seizures not fully controlled with one or two concomitant antiepileptic drugs (AEDs).
The study was designed to evaluate the efficacy and safety of brivaracetam 100 or 200 mg/day (without titration) compared with placebo in this population.
The results showed that brivaracetam reduced the frequency of partial-onset seizures and improved responder rates compared with placebo, both with statistical significance. The most commonly reported adverse events were somnolence, dizziness, fatigue, and headache.
Based on the results of the brivaracetam phase III program, a new drug application is expected to be submitted to the FDA in early 2015.
The new phase III trial was a randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of adjunctive brivaracetam (100 and 200 mg/day) compared with placebo over a 12-week treatment period in 768 focal epilepsy patients (aged 16 to 80 years) with partial-onset seizures not fully controlled despite treatment with one or two concomitant AEDs. The trial’s primary endpoint was the percent reduction compared with placebo in the frequency of partial-onset seizures over the treatment period standardized to a 4-week duration.
Epilepsy is a chronic neurological disorder affecting approximately 65 million people worldwide. It 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; and 3) diagnosis of an epilepsy syndrome.
Although epilepsy may be linked to factors such as health conditions, race, and age, it can occur in anyone at any age, and approximately 1 in 26 people will develop the disorder in his or her lifetime.
Partial seizures begin with an electrical discharge in one area of the brain. The causes of partial seizures include head injury, brain infection, stroke, a tumor, and cortical dysplasia. Many times, no known cause is found, but genetic factors may be important in some partial seizures.
Source: UCB; July 23, 2014.