Pivotal trial results Population Data

A strong
treatment
foundation
with BRIVIACT1

Not an actual patient.

Pivotal trial results

BRIVIACT efficacy extrapolated for pediatric patients

Effectiveness determined through extrapolation from adult efficacy data to children 1 month and older1

Percent reduction (BRIVIACT adjunctive therapy over placebo) in focal
seizure frequency adjusted to 28 days during the treatment period1

BRIVIACT® + current therapy, percentage reduction in focal seizure frequency graph BRIVIACT® + current therapy, percentage reduction in focal seizure frequency graph

*

Statistically significant based on testing procedure with alpha=0.05.1

Study Design1
  • Effectiveness was established in 3 fixed-dose, randomized, double-blind, placebo-controlled, multicenter studies with a 12-week treatment period, and comprised 1,550 adult patients
  • Enrolled adult patients had focal seizures that were not adequately controlled by 1 to 2 concomitant ASMs
  • Patients taking concomitant levetiracetam were excluded from Study 3

ASM=antiseizure medication.

Population data

BRIVIACT efficacy was studied in a challenging pediatric population2

The majority of these patients (58%) had taken at least 2 prior ASMs and were all on concomitant ASMs2

Pediatric trial results2

Pediatric trial results
Pediatric trial results
Pediatric trial results

*Patients without seizures in baseline were excluded. Number of seizure days
standardized to a 28-day duration.2

†With or without secondary generalization and no primary generalized seizures at baseline.2

Study Design2
  • Phase 2a, open-label, single-arm, fixed 3-step dose-escalation trial
  • Short-term safety and tolerability, pharmacokinetics, preliminary efficacy of BRIVIACT oral solution. Efficacy analyses were exploratory
  • Pediatric patients 1 month to <16 years of age
  • 1-week baseline period, 3-week evaluation period
  • In the treatment period, BRIVIACT oral solution dosage was divided into 2 daily doses and increased each week to approximately 0.8, 1.6, and 3.2 mg/kg/day for patients aged ≥8 years, and 1.0, 2.0, and 4.0 mg/kg/day for patients aged <8 years
  • 99 patients were enrolled in the trial. 52 patients with focal seizures were included in the safety analysis, and 50 were included in the efficacy analysis. Only those patients experiencing seizures in the 1-week baseline period (n=37) were included in the seizure reduction and responder rate analyses. All 50 patients with focal seizures were included in the seizure freedom analysis

Explore the safety and tolerability of BRIVIACT

See the Safety Data

References: 1. BRIVIACT® (brivaracetam): prescribing information. Smyrna, GA: UCB, Inc. 2. Liu E, Dilley D, McDonough B, Stockis A, Daniels T. Safety and tolerability of adjunctive brivaracetam in pediatric patients <16 years with epilepsy: an open-label trial. Paediatr Drugs. 2019;21(4):291-301. doi:10.1007/s40272-019-00332-y

Indication

BRIVIACT® (brivaracetam) CV is indicated for the treatment of partial-onset seizures in patients 1 month of age and older.

Important Safety Information

WARNINGS AND PRECAUTIONS

  • Suicidal Behavior and Ideation: Antiepileptic drugs, including BRIVIACT, increase the risk of suicidal behavior and ideation. Monitor patients taking BRIVIACT for the emergence or worsening of depression; unusual changes in mood or behavior; or suicidal thoughts, behavior, or self-harm. Advise patients, their caregivers, and/or families to be alert for these behavioral changes and report them immediately to a healthcare provider.
  • Neurological Adverse Reactions: BRIVIACT causes somnolence, fatigue, dizziness, and disturbance in coordination. Somnolence and fatigue-related adverse reactions were reported in 25% of adult patients taking at least 50 mg per day of BRIVIACT compared to 14% of adult patients taking placebo. Dizziness and disturbance in gait and coordination were reported in 16% of adult patients taking at least 50 mg per day of BRIVIACT compared to 10% of adult patients taking placebo. The risk is greatest early in treatment but can occur at any time. Monitor patients for these signs and symptoms and advise them not to drive or operate machinery until they have gained sufficient experience on BRIVIACT.
  • Psychiatric Adverse Reactions: BRIVIACT causes psychiatric adverse reactions, including non-psychotic and psychotic symptoms. These events were reported in approximately 13% of adult patients taking at least 50 mg per day of BRIVIACT compared to 8% of adult patients taking placebo. A total of 1.7% of adult patients taking BRIVIACT discontinued treatment due to psychiatric reactions compared to 1.3% of patients taking placebo. Psychiatric adverse reactions were also observed in open-label pediatric trials and were generally similar to those observed in adults. Advise patients to report these symptoms immediately to a healthcare provider.
  • Hypersensitivity: BRIVIACT can cause hypersensitivity reactions. Bronchospasm and angioedema have been reported. Discontinue BRIVIACT if a patient develops a hypersensitivity reaction after treatment. BRIVIACT is contraindicated in patients with a prior hypersensitivity reaction to brivaracetam or any of the inactive ingredients.
  • Withdrawal of Antiepileptic Drugs: As with all antiepileptic drugs, BRIVIACT should generally be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus.

DOSING CONSIDERATIONS

  • Dose adjustments are recommended for patients with all stages of hepatic impairment.
  • When BRIVIACT is co-administered with rifampin, an increase in the BRIVIACT dose is recommended.

ADVERSE REACTIONS

In adult adjunctive therapy placebo-controlled clinical trials, the most common adverse reactions (at least 5% for BRIVIACT and at least 2% more frequently than placebo) were somnolence and sedation, dizziness, fatigue, and nausea and vomiting symptoms. Adverse reactions reported in clinical studies of pediatric patients were generally similar to those in adult patients. Adverse reactions with BRIVIACT injection in adult and pediatric patients were generally similar to those observed with BRIVIACT tablets. Other adverse events that occurred in adult patients who received BRIVIACT injection included dysgeusia, euphoric mood, feeling drunk, and infusion site pain.

BRIVIACT is a Schedule V controlled substance.

Please see full Prescribing Information.