What is the role of brivaracetam (Briviact) in the treatment of epilepsy?

Updated: Jan 28, 2020
  • Author: Juan G Ochoa, MD; Chief Editor: Selim R Benbadis, MD  more...
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Answer

Answer

The precise mechanism of action for brivaracetam (Briviact) is unknown. Brivaracetam displays a high and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain, which may contribute to the anticonvulsant effect. It is indicated as monotherapy or adjunctive therapy for partial-onset seizures in adults and children aged 16 y or older.

Approval was based on results from a randomized, double-blind, placebo-controlled, multicenter study (n=768) that enrolled patients with uncontrolled POS despite ongoing treatment with 1-2 antiepileptic drugs. Percent reduction in POS compared with placebo was 22.8% and 23.2% for brivaracetam 100 mg/day and 200 mg/day respectively (p < 0.001). [92]

In September 2017, FDA approved brivaracetam (Brivact) as monotherapy for partial-onset (focal) seizures in patients aged ≥16 years with epilepsy. The supplemental New Drug Application (sNDA) approval was based on the FDA guidance that allows for extrapolation of the safety and efficacy of drugs approved as adjunctive therapy for treatment of partial-onset seizures. The sNDA submitted to support the monotherapy indication included clinical data involving over 2,400 adults with partial-onset seizures. 

The starting dose is 50 mg PO BID. Based on individual patient tolerability and therapeutic response, adjust dose down to 25 mg BID (50 mg/day) or up to 100 mg BID (200 mg/day). Patient with any degree of hepatic impairment should be initiated at a lower dose (25 mg BID) and should not exceed a daily dose of 75 mg BID (150 mg/day).


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