- Data from three Phase 3 studies showed BRIVLERA™ significantly reduced the frequency of partial-onset seizures over placebo1
TORONTO, May 26, 2016 /CNW/ - UCB Canada Inc. today announced that BRIVLERA™ is now available across Canada as adjunctive therapy in the management of partial-onset seizures in adult patients (≥18 years of age) with epilepsy who are not satisfactorily controlled with conventional therapy.
Approved by Health Canada on March 9th 2016, BRIVLERA™ is the culmination of more than eight years of clinical trials involving more than 2,400 adult patients with partial-onset seizures.
"Canadian epilepsy patients will benefit from BRIVLERA™, a new anti-seizure medication that works differently from those currently available in Canada. It showed significant treatment response with good tolerance in pivotal trials taken in combination with other seizure medications," said Dr. Neelan Pillay, Adult Epileptologist, Clinical Professor at the Cumming School of Medicine, University of Calgary, Foothills Medical Centre, Calgary, Alberta.
"We are pleased to introduce BRIVLERA™ as a new therapeutic option that may make a difference in the lives of people living with epilepsy in Canada," said Ian Tu, Head, Neurology Patient Value Unit, UCB Canada. "The development of this new innovation builds upon our longstanding heritage in developing meaningful treatment solutions for people living with epilepsy."
The approved indication is based on data from three pivotal Phase 3 studies in which BRIVLERA™ demonstrated efficacy over placebo in reducing partial-onset seizure frequency during the treatment period.1
The most frequently reported adverse events (>10%) with BRIVLERA™ treatment were: somnolence (14.3%) and dizziness (11.0%). Somnolence and fatigue were reported at a higher incidence with increasing dose. The most common adverse events requiring clinical intervention (dose adjustment/interruption or requiring additional therapy) were cough (1.5%), nausea (1.0%), and fatigue (0.8%). The discontinuation rate due to adverse events was 6.0%, 7.4%, and 6.8% for patients randomized to receive BRIVLERA™ at the recommended doses of 50 mg, 100 mg, and 200 mg/day, respectively, and 3.5% in patients randomized to receive placebo. The adverse reactions most commonly leading to discontinuation were dizziness (0.8%), depression (0.5%), and fatigue (0.5%).1
About PrBRIVLERA™ (brivaracetam)
BRIVLERA™ is a new molecular entity that was rationally designed and developed by UCB. BRIVLERA™ displays a high and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain, which may contribute to the anticonvulsant effect. However, the precise mechanism of action by which BRIVLERA™ exerts its anticonvulsant activity is not known. BRIVLERA™ will be available in three formulations (film-coated tablets, oral solution, and intravenous).1,2
BRIVLERA™ is a trademark of the UCB Group of Companies.
Epilepsy is a chronic neurological disorder affecting approximately 65 million people worldwide, including about 1 in 100 people in Canada. While epilepsy has the highest rate of new cases in seniors and young children, it can affect people of any age, race and sex. Next to migraine headaches, epilepsy is the most common neurological disorder.
There are many different types of epilepsy but the main characteristic of the condition is recurrent seizures. Seizures are classified by the pattern of onset—partial seizures start in one part of the brain and generalized seizures are characterized by widespread involvement of the whole brain.
About UCB in Epilepsy
UCB has a rich heritage in epilepsy with more than 20 years of experience in the research and development of anti-epileptic drugs. As a company with a long-term commitment to epilepsy research, our goal is to address unmet medical needs. Our scientists are proud to contribute to advances in the understanding of epilepsy and its treatment. We partner and create super-networks with world-leading scientists and clinicians in academic institutions, pharmaceutical companies and other organizations who share our goals. At UCB, we are inspired by patients and driven by science in our commitment to support patients with epilepsy.
About UCB Canada Inc.
Inspired by patients and driven by science, UCB Canada Inc. is a biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe auto-immune and central nervous system diseases. For more information, please consult www.ucb.com/worldwide/canada.
1. BRIVLERA™ Product Monograph, March 9, 2016.
2. Klein, P et al. brivaracetam for the treatment of epilepsy. Expert Opin Pharmacother, 2016.
3. Epilepsy Ontario: http://epilepsyontario.org/about-epilepsy/what-is-epilepsy/, April 14, 2016.
4. Canadian Epilepsy Alliance: http://epilepsymatters.com/information-resources/epilepsy-faq/explaining-epilepsy/#whatisepilepsy, April 14, 2016.
SOURCE UCB Canada Inc.
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