Belgium-based biopharmaceutical firm UCB has reported positive topline results from the latest Phase III trial of brivaracetam, as adjunctive treatment in adult focal epilepsy patients with partial-onset seizures.
The trial was designed to assess the efficacy and safety of brivaracetam 100mg/day and 200mg/day, without titration compared with placebo in these patients over a 12-week treatment period.
A total of 768 randomised focal epilepsy patients aged between 16 and 80 years with partial-onset seizures, not fully controlled despite treatment with one or two concomitant AEDs, were enrolled in the double-blind, placebo-controlled, multi-centre, parallel-group trial.
The Phase III trial results showed that brivaracetam reduced partial-onset seizure frequency and improved responder rates, both with statistical significance.
UCB CEO-elect Jean-Christophe Tellier said: "Today's positive results with brivaracetam represent a significant milestone in our strategy to deliver new treatment options for people with severe diseases.
"As the newest product to emerge from our late-stage pipeline, brivaracetam is leading the way for UCB's new era of patient-centric solutions.
"We are proud to provide AED options for the epilepsy community today, and remain committed to addressing the unmet needs of adult patients who continue to experience uncontrolled seizures."
The primary endpoint for the European regulatory authorities is the 50% responder rate for partial-onset seizure frequency compared with placebo, over the treatment period standardised to a 28-day duration. The company said that the primary endpoint is similar for the US Food and Drug Administration (FDA).
UCB chief medical officer and executive vice-president Iris Loew Friedrich said: "The positive data from the most recent Phase III study demonstrated robust and clinically relevant seizure reduction in predominantly treatment resistant patients, and tolerability was consistent with previous brivaracetam trials.
"This study was the largest Phase III study conducted in epilepsy patients with partial-onset seizures. Overall, the brivaracetam development programme has involved over 3,000 people and offers over eight years of clinical experience with some patients.
"We look forward to discussing the data with the regulatory authorities and the scientific community."
Based on the results of the brivaracetam Phase III programme, the company intends to submit a new drug application (NDA) to the US Food & Drug Administration (FDA) and a Marketing Authorization Application to the European Medicines Agency (EMA) in early 2015.
The most commonly reported adverse events observed were somnolence, dizziness, fatigue and headache.