BRIVIACT® is a new molecular entity that was approved by the U.S. Food and Drug Administration (FDA) on February 18, 2016, providing an important new treatment option for those living with epilepsy. On May 12, 2016, the Drug Enforcement Administration (DEA) listed BRIVIACT® as a Schedule V controlled substance.
Gradual dose escalation is not required when initiating treatment with BRIVIACT®. The recommended starting dosage is 50 mg twice daily (100 mg per day). Based on individual patient tolerability and therapeutic response, the dosage may be adjusted down to 25 mg twice daily (50 mg per day) or up to 100 mg twice daily (200 mg per day).
“What It is important to note that with BRIVIACT® is that titration is not required to achieve a therapeutic dose. Patients can start their very first BRIVIACT® treatment with a therapeutic dose. This makes it a useful addition to the current antiepileptic medication armamentarium,” said Dr. Pavel Klein, MD, Director, Mid-Atlantic Epilepsy and Sleep Center, Bethesda, Maryland.
BRIVIACT® is associated with important warnings and precautions including suicidal behavior and ideation, somnolence, fatigue, dizziness, disturbance in gait and coordination, psychiatric adverse reactions including non-psychotic and psychotic symptoms, and hypersensitivity reactions (bronchospasm and angioedema). BRIVIACT®is contraindicated in patients with a prior hypersensitivity reaction to brivaracetam or any of the inactive ingredients. The most common adverse reactions (at least 5% for BRIVIACT®and at least 2% more frequently than placebo) are somnolence and sedation, dizziness, fatigue, and nausea and vomiting symptoms.1
Patients with epilepsy are living with significant unmet needs. Approximately 30% of people with epilepsy remain uncontrolled on existing therapies and still experience seizures, which can lead to devastating physical and emotional consequences.2,3 Epilepsy can develop in anyone at any age, and approximately one in 26 people will develop epilepsy in their lifetime.4
“At UCB, we are constantly inspired to improve patients’ lives, which is why we are excited that BRIVIACT® is now available in U.S. pharmacies. This is an important addition to our existing epilepsy portfolio," said Jeff Wren, Head of Neurology and Executive Vice President at UCB. “We remain steadfast in our commitment to addressing unmet needs for people with epilepsy, and will continue our efforts to bring this important treatment to even more patients worldwide.”
In January 2016, the European Commission granted the marketing authorization for BRIVIACT® as an adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalization in adult and adolescent patients from 16 years of age with epilepsy. In the EU, BRIVIACT® is already available to patients in the UK, Germany, and Denmark. In Canada, brivaracetam is approved as the trade name BRIVLERA®. UCB has submitted additional regulatory applications for brivaracetam in other countries including Australia, Brazil, Russia, Switzerland and Turkey.