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A CONFIDENT START FOR THEIR
LONG-TERM JOURNEY

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

BRIVIACT offers a confident start from Day 1 with no titration period1

PERCENT REDUCTION (BRIVIACT ADJUNCTIVE THERAPY OVER PLACEBO) IN PARTIAL-ONSET SEIZURE FREQUENCY ADJUSTED TO 28 DAYS DURING THE TREATMENT PERIOD IN ADULTS1PERCENT REDUCTION (BRIVIACT ADJUNCTIVE THERAPY OVER PLACEBO) IN PARTIAL-ONSET SEIZURE FREQUENCY ADJUSTED TO 28 DAYS DURING THE TREATMENT PERIOD IN ADULTS1

PIVOTAL TRIAL PROGRAM DESIGN1

  • Effectiveness was established over a 12-week treatment period in three fixed-dose, randomized, double-blind, placebo-controlled, multicenter studies, which included 1550 adult patients
  • Enrolled adult patients had partial-onset seizures that were not adequately controlled by 1 to 2 concomitant AEDs
  • Adult patients taking concomitant levetiracetam were excluded from Study 3

AEDs=antiepileptic drugs.

Efficacy and tolerability were further demonstrated across all doses

≥50% RESPONDER RATE IN THE POOLED PHASE 3 TRIALS2≥50% RESPONDER RATE IN THE POOLED PHASE 3 TRIALS2
  • Pooled analysis of three pivotal trials2
  • ≥50% responder rate based on percent reduction in focal seizure frequency from baseline to the end of treatment period (12 weeks) was a primary or secondary end point in all 3 trials3-5
  • 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.

Sustained responder rates were evaluated from Day 1

TIME TO ONSET OF SUSTAINED ≥50% RESPONDER STATUS IN A POST HOC ANALYSIS OF THE POOLED PHASE 3 TRIALS6TIME TO ONSET OF SUSTAINED ≥50% RESPONDER STATUS IN A POST HOC ANALYSIS OF THE POOLED PHASE 3 TRIALS6

STUDY DESIGN6

  • Patients were classified as sustained ≥50% responders on a particular day if they completed the entire treatment period through day 84 and were a ≥50% responder both on that day and for every successive day through day 84
  • By definition, patients discontinuing during the treatment period could not achieve sustained responder status
  • Data presented excludes patients taking concomitant levetiracetam
  • On day 1, 15.5% (BRIVIACT 50 mg/day), 18.1% (BRIVIACT 100 mg/day), and 19.4% (BRIVIACT 200 mg/day) of patients achieved sustained ≥50% responder status, vs. 6.7% for placebo

TEAEs REPORTED IN ≥5.0% OF PATIENTS TAKING BRIVIACT DURING THE FIRST WEEK WERE6

  • Somnolence (11.2% with BRIVIACT vs. 4.8% with placebo)
  • Dizziness (8.0% with BRIVIACT vs. 2.4% with placebo)
  • Fatigue (5.7% with BRIVIACT vs. 1.1% with placebo)

This was consistent with the most common adverse events across the whole study period. 
TEAEs=treatment-emergent adverse events.

Time course of efficacy, discontinuation, and adverse events

MONTH 1 VIEW OF BRIVIACT RESPONDERS2

KAPLAN-MEIER ESTIMATES OF TIME TO ≥50% RESPONDER RATE IN A POST-HOC ANALYSIS OF THE POOLED PHASE 3 TRIALS KAPLAN-MEIER ESTIMATES OF TIME TO ≥50% RESPONDER RATE IN A POST-HOC ANALYSIS OF THE POOLED PHASE 3 TRIALS

STUDY DESIGN2

  • Post hoc analysis of pooled data from the pivotal trials
  • Kaplan-Meier estimates of time to 50% response was assessed weekly over the 12-week evaluation period
    • The efficacy analysis excluded patients taking concomitant levetiracetam
  • Incidences of TEAEs and discontinuation were assessed weekly over a 12-week evaluation period7
    • The safety analysis included all patients who took at least one dose of study drug or placebo

INCIDENCE OF PATIENT DISCONTINUATIONS DECREASED AT WEEK 22

Incidence of teaes leading to permanent discontinuation throughout the 12-week evaluation period (post hoc analysis)Incidence of teaes leading to permanent discontinuation throughout the 12-week evaluation period (post hoc analysis)

INCIDENCE OF TEAEs DECREASED AT WEEK 27

Incidence of drug-related teaes throughout the 12-week evaluation period (post hoc analysis)Incidence of drug-related teaes throughout the 12-week evaluation period (post hoc analysis)

TEAEs=treatment-emergent adverse events.

Five-year view of BRIVIACT long-term retention rates

Kaplan-Meier estimate of percentage of patients remaining on treatment in a long-term pooled study of Kaplan-Meier estimate of percentage of patients remaining on treatment in a long-term pooled study of

STUDY DESIGN AND RESULTS8

  • The modified safety population was comprised of adult patients with epilepsy who took part in the Phase 2b and Phase 3 trials, were uncontrolled by 1-3 AEDs, and who continued into the open-label, long-term follow-up trial (N=2,051; mean age: 37.2 years). The recommended initial dose was 50 mg/day and a flexible dosing regimen (≤200 mg/day) was permitted
  • Limited exposure was seen at the later time points, with 41 patients (1.7%) continuing treatment for ≥8 years, and 3 patients (0.1%) continuing for ≥8.5 years
  • Over the course of 5 years, the most common TEAEs were headache (20.9%), dizziness (17.5%), and somnolence (15.2%)

AEDs=antiepileptic drugs.
TEAEs=treatment-emergent adverse events.

BRIVIACT offers simple 1:1 dose conversion between formulations1

Dose conversionDose conversionAdult dosingAdult dosing
  • Dose adjustments are recommended for patients with all stages of hepatic impairment1
  • When BRIVIACT is co-administered with rifampin, an increase in the BRIVIACT dose is recommended1

BRIVIACT exhibits a linear and time-independent pharmacokinetic profile1

PharmacokineticPharmacokinetic

Affordability and accessibility matter

UCB is committed to making BRIVIACT accessible and affordable for the majority of eligible patients across the US.§

A Patient Savings Card can help minimize
out-of-pocket costs for eligible patients who may pay
as little as $10 for a 30-day supply of BRIVIACT.§

 Savings card

Direct your patients to BRIVIACT.com/savings to check eligibility and download a Patient Savings Card,
or request one from ucbCARES® at
1-844-599-2273.

§ELIGIBILITY CRITERIA AND TERMS
Savings card is not valid for use by patients who are covered by any federally funded or state-funded healthcare program (including, but not limited to, Medicare [Part D and Medigap] and those who are Medicare-eligible and enrolled in an employer-sponsored health plan for retirees, Medicaid, any state pharmaceutical assistance program, TRICARE, VA, or DoD), or for cash-paying patients. A valid BRIVIACT prescription consistent with the approved FDA labeling is required. Other Eligibility Criteria and Terms apply. Full Eligibility Criteria and Terms are available here or upon request by calling ucbCARES® at 1-844-599-CARE (2273).

Need assistance?

Contact ucbCARES® for additional information about UCB products, patient resources, and financial assistance.

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

References

  1. BRIVIACT® (brivaracetam): package insert. Smyrna, GA: UCB, Inc.
  2. Data on file. UCB, Inc. 
  3. Klein P, Schiemann J, Sperling MR, et al. A randomized, double-blind, placebo-controlled, multicenter, parallel-group study to evaluate the efficacy and safety of adjunctive brivaracetam in adult patients with uncontrolled partial-onset seizures. Epilepsia. 2015;56(12):1890-1898. 
  4. Biton V, Berkovic SF, Abou-Khalil B, et al. Brivaracetam as adjunctive treatment for uncontrolled partial epilepsy in adults: A phase III randomized, double-blind, placebo-controlled trial. Epilepsia. 2014;55(1):57-66. 
  5. Ryvlin P, Werhahn KJ, Blaszczyk B, et al. Adjunctive brivaracetam in adults with uncontrolled focal epilepsy: Results from a double-blind, randomized, placebo-controlled trial. Epilepsia. 2014;55(1):47-56.  
  6. Klein P, Johnson ME, Schiemann J, et al. Time to onset of sustained ≥50% responder status in patients with focal (partial-onset) seizures in three phrase III studies of adjunctive brivaracetam treatment. Epilepsia. 2017;58(2):e21–e25. 
  7. Meador KJ, Laloyaux C, Elmoufti S, et al. Time course of drug-related treatment-emergent adverse side effects of brivaracetam. Epilpesy Behav. 2020;111:doi:10.1016/j.yebeh.2020.107212.Epup 2020 Jun.
  8. Toledo M, Whitesides J, Schiemann J, et al. Safety, tolerability, and seizure control during long-term treatment with adjunctive brivaracetam for partial-onset seizures. Epilepsia. 2016;57(7):1139- 1151.
  9. Stockis A, Hartstra J, Mollet M, et al. Bioavailability and bioequivalence comparison of brivaracetam 10, 50, 75, and 100 mg tablets and 100 mg intravenous bolus. Epilepsia. 2016;57(8):1288-1293.
  10. Nicolas JM, Hannestad J, Holden D, et al. Brivaracetam, a selective high-affinity synaptic vesicle protein 2A (SVA2) ligand with preclinical evidence of high brain permeability and fast onset of action. Epilepsia. 2016;57:201-209.
  11. Klein P, Diaz A, Gasalla T, et al. A review of the pharmacology and clinical efficacy of brivaracetam. Clin Pharmacol. 2018;10:1-22.