BETHESDA, MD 19 Feb 2016—
FDA and Brussels, Belgium-based UCB today announced the approval of brivaracetam as adjunct therapy for the treatment of partial seizures in patients with epilepsy who are at least 16 years of age.
UCB will market brivaracetam as Briviact in the United States. According to the labeling (PDF) for brivaracetam, the drug will be available as oral tablets and oral solution and in a formulation for i.v. injection.
UCB described brivaracetam as a rationally designed anticonvulsant with high, selective affinity for synaptic vesicle protein 2A in the brain. The drug's precise mechanism of action at reducing seizures is not known.
According to the labeling, the recommended starting dosage of brivaracetam is 50 mg taken twice daily. The dosage may be reduced to 25 mg twice daily or increased to 100 mg twice daily, depending on the patient's response. Gradual dosage adjustments are not necessary, the labeling states.
Treatment may be initiated with the oral or injectable formulations of brivaracetam. The orally administered formulations may be taken with or without food. The injectable version, which was given for no more than four consecutive days in the clinical studies, is intended for use when oral administration is temporarily not feasible.
In placebo-controlled clinical trials involving 1550 patients with epilepsy, brivaracetam, when used with other antiepileptic drugs, reduced the frequency of partial seizures. Information about the studies, designated
and N01358 is available at the federal Clinicaltrials.gov website.
According to UCB, adverse events that affected at least 5% of clinical trial participants treated with at least 50 mg of brivaracetam per day included somnolence and sedation, dizziness, fatigue, and nausea and vomiting. The use of brivaracetam was also associated with psychiatric symptoms.
Bronchospasm and angioedema have also been reported in patients treated with brivaracetam. Brivaracetam is contraindicated in patients with a history of these or other hypersensitivity reactions to the drug.
The labeling for brivaracetam includes an FDA-required Medication Guide describing the drug's status as a controlled substance. The Medication Guide also warns patients that the use of brivaracetam or other antiepileptic drugs may cause suicidal thoughts or actions.
UCB said it anticipates the Drug Enforcement Administration placing brivaracetam in a controlled-substance schedule in the next 90 days.
Brivaracetam tablets will be sold in 10-, 25-, 50-, 75-, and 100-mg strengths in bottles of 60 tablets each. All tablet versions except the 10- and 75-mg formulations will also be sold in 100-tablet unit dose packs.
Brivaracetam oral solution, 10 mg/mL, will be sold in 300-mL bottles. The injectable formulation will be available in cartons of 10 vials, each containing 50 mg of the drug.
All formulations should be stored at controlled room temperature. The oral solution should be discarded if not used within five months after first opening the bottle.