Publicado 14/05/2018 7:00:57CET
UCB has a rich heritage in epilepsy with over 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.
BRIVIACT (brivaracetam) is a new molecular entity that was rationally designed and developed by UCB.
Brivaracetam 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 BRIVIACT exerts its anticonvulsant activity is not known.
In the U.S., BRIVIACT(R) (brivaracetam) CV is indicated for the treatment of partial-onset seizures in patients 4 years of age and older. As the safety of BRIVIACT injection in pediatric patients has not been established, BRIVIACT injection is indicated for the treatment of partial-onset seizures only in adult patients (16 years of age and older).
In the European Union, BRIVIACT is approved as adjunctive therapy in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy. The European Medicines Agency has different regulatory requirements from FDA for approval of monotherapy indications.
Important Safety Information about BRIVIACT(R) in the U.S. 
Warnings and Precautions
-- Suicidal Behavior and Ideation: Anti-epileptic drugs, including BRIVIACT, increase the risk of suicidal behavior and ideation. Monitor patients taking BRIVIACT for the emergence or worsening of depression; unusual changes in mood or behavior; or suicidal thoughts, behavior, or self-harm. Advise patients, their caregivers, and/or families to be alert for these behavioral changes and report them immediately to a healthcare provider.
-- Neurological Adverse Reactions: BRIVIACT causes somnolence, fatigue, dizziness, and disturbance in coordination. Somnolence and fatigue-related adverse reactions were reported in 25% of adult patients taking at least 50 mg per day of BRIVIACT compared to 14% of adult patients taking placebo. Dizziness and disturbance in gait and coordination were reported in 16% of adult patients taking at least 50 mg per day of BRIVIACT compared to 10% of adult patients taking placebo. The risk is greatest early in treatment but can occur at any time. Monitor patients for these signs and symptoms and advise them not to drive or operate machinery until they have gained sufficient experience on BRIVIACT.
-- Psychiatric Adverse Reactions: BRIVIACT causes psychiatric adverse reactions, including non-psychotic and psychotic symptoms. These events were reported in approximately 13% of adult patients taking at least 50 mg per day of BRIVIACT compared to 8% of adult patients taking placebo. A total of 1.7% of adult patients taking BRIVIACT discontinued treatment due to psychiatric reactions compared to 1.3% of patients taking placebo. Psychiatric adverse reactions were also observed in open-label pediatric trials and were generally similar to those observed in adults. Advise patients to report these symptoms immediately to a healthcare provider.
-- Hypersensitivity: BRIVIACT can cause hypersensitivity reactions. Bronchospasm and angioedema have been reported. Discontinue BRIVIACT if a patient develops a hypersensitivity reaction after treatment. BRIVIACT is contraindicated in patients with a prior hypersensitivity reaction to brivaracetam or any of the inactive ingredients.
-- Withdrawal of Anti-epileptic Drugs: As with all anti-epileptic drugs, BRIVIACT should generally be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus.
-- Dose adjustments are recommended for patients with all stages of hepatic impairment.
-- When BRIVIACT is co-administered with rifampin, an increase in the BRIVIACT dose is recommended.
ADVERSE REACTIONS In adult adjunctive therapy placebo-controlled clinical trials, the most common adverse reactions (at least 5% for BRIVIACT and at least 2% more frequently than placebo) were somnolence and sedation, dizziness, fatigue, and nausea and vomiting symptoms. Adverse reactions reported in clinical studies of pediatric patients 4 years to less than 16 years of age were generally similar to those in adult patients.
BRIVIACT is a Schedule V controlled substance.
Please refer to full Prescribing Information at http://www.briviact.com/briviact-PI.pdf
For more information on BRIVIACT(R), contact 844-599-CARE (2273).
BRIVIACT(R) is a registered trademark of the UCB Group of Companies.
About UCB UCB, Brussels, Belgium (http://www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 7500 people in approximately 40 countries, the company generated revenue of EUR 4.2 billion in 2016. UCB is listed on Euronext Brussels . Follow us on Twitter: @UCB_news
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References: 1. Shinnar, S., Pellock, J.M. Update on the epidemiology and prognosis of pediatric epilepsy. J Child Neurol. 2002;17(Suppl 1):S4-17.
2. Zack MM, Kobau R. National and State Estimates of the Numbers of Adults and Children with Active Epilepsy - United States, 2015. MMWR Morb Mortal Wkly Rep 2017;66:821-825. DOI: http://dx.doi.org/10.15585/mmwr.mm6631a1 accessed 02 May 2018.