FOR PARTIAL-ONSET SEIZURES USE VIMPAT® AS
ADJUNCTIVE THERAPY OR MONOTHERAPY FOR CHILDREN
(4 YEARS OF AGE AND OLDER).
The pediatric indication for VIMPAT is based on the principle of extrapolation of efficacy data from adults and is supported by safety and pharmacokinetics data collected in children.
The efficacy of VIMPAT in pediatric patients 4 years of age and older with partial-onset seizures was confirmed in a placebo-controlled pediatric trial.
VIMPAT® is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.
VIMPAT is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older.
IMPORTANT SAFETY INFORMATION
VIMPAT is associated with important warnings and precautions including suicidal behavior and ideation, dizziness and ataxia, cardiac rhythm and conduction abnormalities, syncope, and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multi-organ hypersensitivity.
In the adult adjunctive placebo-controlled trials for partial-onset seizures, the most common adverse reactions (≥10% and greater than placebo) were dizziness, headache, nausea, and diplopia. In the adult monotherapy clinical trial, adverse reactions were generally similar to those observed and attributed to drug in adjunctive placebo-controlled trials, with the exception of insomnia (observed at a higher rate of ≥2%). Pediatric adverse reactions were similar to those seen in adult patients.
Primary Generalized Tonic-Clonic Seizures
In the adjunctive therapy placebo-controlled trial for primary generalized tonic-clonic seizures, the adverse reactions were generally similar to those that occurred in the partial-onset seizures trials. The adverse reactions most commonly reported were dizziness, somnolence, headache, and nausea.
VIMPAT is a Schedule V controlled substance.
VIMPAT IS APPROVED FOR PARTIAL-ONSET SEIZURE TREATMENT OF PEDIATRIC PATIENTS AGES 4 YEARS AND OLDER BASED ON EXTRAPOLATION OF DATA FROM ADULT STUDIES, INCLUDING:
- Three 12-week, randomized, multicenter, placebo-controlled, double-blind clinical adjunctive therapy trials in adult patients at 200 mg/day and 400 mg/day3-5
- A conversion-to-monotherapy trial in adult patients using a historical control group8
VIMPAT pediatric efficacy also was studied in a placebo-controlled adjunctive trial that demonstrated efficacy in pediatric patients 4 years of age and older with partial-onset seizures with or without secondary generalization.1
ADJUNCTIVE THERAPY IN PEDIATRIC PATIENTS (4 years of age and older)
VIMPAT ESTABLISHED ADULT EFFICACY FOR PARTIAL-ONSET SEIZURES HAS
EXTRAPOLATED FOR PEDIATRIC PATIENTS.2
Adult efficacy was demonstrated in patients with partial-onset seizures and has been extrapolated to children ages 4 and older according to FDA guidelines.
ADULT ADJUNCTIVE EFFICACY
VIMPAT demonstrated significant control of partial-onset seizures in adults with or without secondary generalization.
- The efficacy of VIMPAT as adjunctive therapy was established in three 12-week, randomized, multicenter, placebo-controlled, double-blind clinical trials at 200 mg/day and 400 mg/day
- Significantly more VIMPAT patients demonstrated a 50% or greater reduction in seizures compared with placebo3-5
- In adult adjunctive placebo-controlled trials (200 mg/day and 400 mg/day), the most common adverse reactions (≥10% and greater than placebo) were dizziness, headache, nausea, and diplopia2
MONOTHERAPY IN PEDIATRIC PATIENTS (4 years of age and older)
FOR MONOTHERAPY, VIMPAT MET THE PREDEFINED CRITERIA
EFFICACY IN ADULTS WITH PARTIAL-ONSET SEIZURES.2,8
VIMPAT USE AS MONOTHERAPY IN ADULTS WITH PARTIAL-ONSET SEIZURES WAS EVALUATED IN A HISTORICAL CONTROL TRIAL
VIMPAT was tested in a conversion-to-monotherapy trial using a historical control group derived from a meta-analysis of data from 8 previous AED monotherapy trials of similar design, which utilized a subtherapeutic dose of an AED as a control.
- VIMPAT met the pre-specified criteria for efficacy at doses of 400 mg/day or 300 mg/day
- VIMPAT demonstrated statistical superiority to the historical control
- In the adult monotherapy clinical trial (300 mg/day and 400 mg/day), adverse reactions were generally similar to those observed and attributed to drug in adult adjunctive placebo-controlled trials, with the exception of insomnia (occurred at a higher rate of ≥2%)
VIMPAT PEDIATRIC EFFICACY WAS STUDIED IN A
PLACEBO-CONTROLLED ADJUNCTIVE TRIAL FOR PARTIAL-ONSET SEIZURES.1
Trial evaluated the efficacy and safety of VIMPAT as adjunctive therapy in 343 children with partial-onset seizures not adequately controlled by 1 to 3 concomitant AEDs.
VIMPAT PEDIATRIC EFFICACY WAS CONFIRMED IN PATIENTS WITH PARTIAL-ONSET SEIZURES.1
Pediatric adjunctive efficacy
VIMPAT demonstrated efficacy in pediatric patients with partial-onset seizures with or without secondary generalization.
PLACEBO IN PEDIATRIC, PLACEBO-CONTROLLED ADJUNCTIVE THERAPY TRIAL
Average median VIMPAT total daily dose during maintenance period
| <30 kg: 10.5 mg/kg/day | ≥30 to <50 kg: 7.4 mg/kg/day | ≥50 kg: 6.2 mg/kg/day |
- Significantly more VIMPAT pediatric patients demonstrated a 50% or greater reduction in seizures
compared to patients taking placebo
- FDA approval was based on the adult efficacy data
- In the pediatric placebo-controlled trial, the most common adverse reactions (≥10%) were dizziness and somnolence
- 1.Data on file. UCB, Inc.
- 2.VIMPAT® (lacosamide): US prescribing information. Smyrna (GA): UCB, Inc.
- 3.Ben-Menachem E, Biton V, Jatuzis D, et al. Efficacy and safety of oral lacosamide as adjunctive therapy in adults with partial-onset seizures. Epilepsia. 2007;48(7):1308-1317.
- 4.Chung S, Sperling MR, Biton V, et al; on behalf of the SP754 Study Group. Lacosamide as adjunctive therapy for partial-onset seizures: a randomized controlled trial. Epilepsia. 2010;51(6):958-967.
- 5.Halász P, Kälviäinen R, Mazurkiewicz-Bełdzińska M, et al. Adjunctive lacosamide for partial-onset seizures: efficacy and safety results from a randomized controlled trial. Epilepsia. 2009;50(3):443-453.
- 8.French JA, Wang S, Warnock B, et al. Historical control monotherapy design in the treatment of epilepsy. Epilepsia. 2010;51(10):1936-1943.