FDA approves Brivaracetam to treat partial onset seizures


A congener of Levetiracetam, Brivaracetam binds more avidly to SV2A (Synaptic Vesicular 2A) protein.

The drug can cause:

(*) Drowsiness: Caution while driving

(*) Suicidal Behaviour

The FDA has given approval based on the data from three clinical trials of 1,550 patients with partial-onset seizures not adequately controlled with 1 to 2 concomitant antiepileptic drugs (AEDs). The efficacy and safety of brivaracetam were studied.

In studies 1 and 2, the primary endpoint was the % reduction in 7-day partial-onset seizure frequency vs. placebo while study 3 evaluated the 28-day partial-onset seizure frequency vs. placebo.

  • In study 1, the Briviact 50 mg and 100 mg treatment groups demonstrated a 9.5% and 17% reduction in the primary endpoint, respectively.
  • In study 2, the Briviact 50 mg treatment group demonstrated a 16.9% statistically significant reduction in the primary endpoint.
  • In study 3, the Briviact 100 mg and 200 mg treatment groups demonstrated a 25.2% and 25.7% statistically significant reduction in the primary endpoint, respectively.

Get the highlights of the prescribing information here.

Drugs<>Therapeutics<>Big Pharma
NateshPrabhu Assistant Professor of Pharmacology Dhanalakshmi Medical College and Hospital, Siruvachur
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One Response to FDA approves Brivaracetam to treat partial onset seizures

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