Pivotal trial results SGTC seizure freedom

Established
efficacy
in focal
seizures1

Veronica is an actual patient
 living with focal seizures.

Pivotal trial results

The established efficacy of BRIVIACT provides a strong treatment foundation

Efficacy and safety were
established in adult trials
without a titration period1

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

Across all 3 trials, low discontinuation rates
due to adverse events were observed1:

  • Placebo: 4%
  • BRIVIACT 50 mg/day: 5%
  • BRIVIACT 100 mg/day: 8%
  • BRIVIACT 200 mg/day: 7%
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.

SGTC seizure freedom

From a baseline of ~3 SGTC seizures per 28 days,

More than 1 in 3 patients achieved zero SGTC seizures in both the short and long term2,3

Short-term (12-week) SGTC seizure freedom rate from a pooled
post hoc analysis2

Short-term (12-week) Sgtc seizure freedom rate from a pooled post-hoc analysis graph Short-term (12-week) Sgtc seizure freedom rate from a pooled post-hoc analysis graph

Long term (5 years)

More than 1 in 3 patients overall (35%) experienced
zero SGTC seizures for at least one year during the
long-term follow-up post hoc analysis3

Approximately half of patients achieved seizure freedom for a year or more when BRIVIACT was used earlier in the treatment regimen4

Patients with ≥1 year SGTC seizure freedom at any time during the long-term
(5-year) follow-up post hoc analysis4

Patients with ≥1 year Sgtc seizure freedom at any time during the long-term (5-Year) follow-up post-hoc analysis graph Patients with ≥1 year Sgtc seizure freedom at any time during the long-term (5-Year) follow-up post-hoc analysis graph

Patients received adjunctive BRIVIACT in either the pivotal trials or the long-term follow-up3

More patients achieved zero SGTC seizures
when BRIVIACT was started earlier4

Study Design2,3
  • 12 weeks: Post hoc analysis of patients with SGTC seizures among their baseline seizures from pooled data of three Phase 3 pivotal trials2
  • 5 years: Post hoc analysis conducted to evaluate the efficacy and tolerability of long-term BRIVIACT treatment in patients ≥16 years of age, who reported SGTC seizures during the 8-week baseline of three Phase 3 pivotal trials and received adjunctive BRIVIACT in either the pivotal trials or the long-term follow-up3
  • Efficacy (concomitant levetiracetam excluded) and tolerability (concomitant levetiracetam included) were assessed from the first day of BRIVIACT in patients who initiated BRIVIACT at 50-200 mg/day3

BRIVIACT was studied in a difficult-to-treat patient population, including refractory patients who had taken 5 or more ASMs (34%)3

SGTC=secondarily generalized tonic-clonic.

Explore the safety and tolerability of BRIVIACT

See the Safety Data

References: 1. BRIVIACT® (brivaracetam) prescribing information. Smyrna, GA: UCB, Inc. 2. Moseley BD, Sperling MR, Asadi-Pooya AA, et al. Efficacy, safety, and tolerability of adjunctive brivaracetam for secondarily generalized tonic-clonic seizures: pooled results from three phase III studies. Epilepsy Res. 2016;127:179-185. doi:10.1016/j.eplepsyres.2016.09.003 3. Moseley BD, Dimova S, Elmoufti S, Laloyaux C, Asadi-Pooya AA. Long-term efficacy and tolerability of adjunctive brivaracetam in adults with focal to bilateral tonic-clonic (secondary generalized) seizures: post hoc pooled analysis. Epilepsy Res. 2021;176:106694. doi:10.1016/j.eplepsyres.2021.106694 4. Moseley BD, Dimova S, Elmoufti S, Laloyaux C, Asadi-Pooya AA. Long-term efficacy and tolerability of adjunctive brivaracetam in adults with focal to bilateral tonic-clonic (secondary-generalized) seizures: post hoc pooled analysis. Epilepsy Res. Journal Pre-proof, 2021.

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.