Briviact (brivaracetam)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

UCB

Approval Status:

Approved February 2016

Specific Treatments:

partial onset seizures related to epilepsy

Therapeutic Areas

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General Information

Briviact (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 by which Briviact exerts its anticonvulsant activity is not known. 

Briviact is specifically indicated as adjunctive therapy in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy.

Briviact is supplied in three formulations: tablet, oral solution and injection for intravenous administration. 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).

Clinical Results

FDA Approval

The FDA approval of Briviact was based on pooled data from three pivotal Phase III studies (N01252, N01253 and N01358). The fixed-dose, randomized, double-blind, placebo-controlled, multicenter studies enrolled 1,550 patients with partial-onset seizures that were not adequately controlled with 1 to 2 concomitant antiepileptic drugs. All trials had an 8-week baseline period, during which patients were required to have at least 8 partial-onset seizures. The baseline period was followed by a 12-week treatment period. There was no titration period in these studies. Study 1 compared doses of Briviact 50 mg/day and 100 mg/day with placebo. Study 2 compared a dose of Briviact 50 mg/day with placebo. Study 3 compared doses of Briviact 100 mg/day and 200 mg/day with placebo. Briviact demonstrated statistically significant reductions over placebo in partial-onset seizure frequency per 28 days (19.5%, 24.4% and 24.0% for Briviact 50, 100 and 200 mg/day respectively, p<0.01). The proportion of patients showing a 50% or greater reduction in partial-onset seizure frequency was 34.2% (50 mg/day), 39.5% (100 mg/day) and 37.8% (200 mg/day), vs. 20.3% for placebo (p<0.01 for all arms).

Side Effects

Adverse effects associated with the use of Briviact may include, but are not limited to, the following:

  • somnolence/sedation
  • dizziness
  • fatigue
  • nausea/vomiting

Mechanism of Action

Briviact (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 by which Briviact exerts its anticonvulsant activity is not known. 

Additional Information

For additional information regarding Briviact or partial onset seizures related to epilepsy, please visit http://www.briviact.com/