Results showed that brivaracetam reduced partial-onset seizure frequency and improved responder rates, both with statistical significance. The most commonly reported adverse events were somnolence, dizziness, fatigue and headache.(3 )
"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," said
"The positive data from the most recent Phase 3 study demonstrated robust and clinically relevant seizure reduction in predominantly treatment resistant patients, and tolerability was consistent with previous brivaracetam trials,("4-6) said Professor Dr.
Based on the results of the brivaracetam Phase 3 program, UCB plans to submit a New Drug Application to the
This Phase 3 study was a randomized, double-blind, placebo-controlled, multicentre, parallel-group study to evaluate the efficacy and safety of adjunctive brivaracetam (100 and 200 mg/day) compared to placebo, over a 12-week treatment period, in 768 randomized focal epilepsy patients (aged 16 to 80 years) with partial-onset seizures, not fully controlled despite treatment with one or two concomitant AEDs.(2,7) 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 standardized to a 28-day duration. The primary endpoint for the
About brivaracetam and the Phase 3 clinical development program
Discovered and developed by UCB, brivaracetam is a highly selective synaptic vesicle protein 2A ligand.(8,9 )
Keywords for this news article include: UCB, Epilepsy, Seizures, Brain Diseases, Central Nervous System Diseases.
Our reports deliver fact-based news of research and discoveries from around the world. Copyright 2014, NewsRx LLC
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