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Lacosamide demonstrated significant control of partial-onset seizures with or without secondary generalizations

Efficacy demonstrated in pooled analysis from
3 placebo-controlled adjunctive-therapy pivotal trials1*

Seizure reduction with lacosamide vs placebo

Chart
Study Design: Age (mean): 40 years; Female 51%, Male 49%; Patients had a mean duration of epilepsy of 24 years; 45% of patients had tried 7 or more AEDs in their lifetime; 84% of patients were on 2 or 3 concomitant AEDs when lacosamide or placebo was added; Average median baseline seizure frequency was 11.5 seizures every 28 days.1
* Per 28 days from baseline to maintenance.
† p<0.05.
‡ p<0.001.
AED=anti-epileptic drug.

Lacosamide demonstrated consistent responder rates

Significant efficacy demonstrated in the 400 mg/day dosage group1

≥50% responder rates from baseline with lacosamide vs placebo

Chart
Chart
Study Design: Age (mean): 40 years; Female 51%, Male 49%; Patients had a mean duration of epilepsy of 24 years; 45% of patients had tried 7 or more AEDs in their lifetime; 84% of patients were on 2 or 3 concomitant AEDs when lacosamide or placebo was added; Average median baseline seizure frequency was 11.5 seizures every 28 days.1

AED=anti-epileptic drug.

Lacosamide is proven to be effective as
monotherapy in partial-onset seizures

In a conversion to monotherapy study,* lacosamide
was statistically superior to a historical control group2†

Kaplan-Meier predicted time to exit:
Patients meeting ≥1 exit criterion‡

Chart
* As per FDA monotherapy approval criteria.
† Lacosamide 300 mg/day also met the pre-specified criteria for efficacy.
‡ During the lacosamide maintenance phase. Exit criteria were 1 or more of the following: (1) doubling of average monthly seizure frequency during any 28 consecutive days; (2) doubling of highest consecutive 2-day seizure frequency; (3) occurrence of a single generalized tonic-clonic seizure; (4) clinically significant prolongation or worsening of overall seizure duration, frequency, type, or pattern considered by the investigator to require trial discontinuation; (5) status epilepticus or new-onset serial/cluster seizures.
Study Design: To be included in Study 1, patients were required to be taking stable doses of 1 or 2 marketed antiepileptic drugs. This treatment continued into the 8-week baseline period. To remain in the study, patients were required to have at least 2 partial-onset seizures per 28 days during the 8-week baseline period. The baseline period was followed by a 3-week titration period, during which lacosamide was added to the ongoing antiepileptic regimen. This was followed by a 16‑week maintenance period (ie, a 6-week withdrawal period for background antiepileptic drugs, followed by a 10-week monotherapy period). Patients were randomized 3 to 1 to receive lacosamide 400 mg/day or lacosamide 300 mg/day. Treatment assignments were blinded. Response to treatment was based upon a comparison of the number of patients who met exit criteria during the maintenance phase, compared to historical controls. The historical control consisted of a pooled analysis of the control groups from 8 studies of similar design, which utilized a sub-therapeutic dose of an antiepileptic drug.
* As per FDA monotherapy approval criteria.
† Lacosamide 300 mg/day also met the pre-specified criteria for efficacy.
‡ During the lacosamide maintenance phase. Exit criteria were 1 or more of the following: (1) doubling of average monthly seizure frequency during any 28 consecutive days; (2) doubling of highest consecutive 2-day seizure frequency; (3) occurrence of a single generalized tonic-clonic seizure; (4) clinically significant prolongation or worsening of overall seizure duration, frequency, type, or pattern considered by the investigator to require trial discontinuation; (5) status epilepticus or new-onset serial/cluster seizures.

INDICATION

MOTPOLY XR is indicated for the treatment of partial-onset seizures in adults and in pediatric patients weighing at least 50 kg.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

  • Antiepileptic drugs increase the risk of suicidal behavior and ideation. Monitor patients for the emergence or worsening of depression, suicidal thoughts or behaviors.

INDICATION

MOTPOLY XR is indicated for the treatment of partial-onset seizures in adults and in pediatric patients weighing at least 50 kg.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

  • Antiepileptic drugs increase the risk of suicidal behavior and ideation. Monitor patients for the emergence or worsening of depression, suicidal thoughts or behaviors.
  • MOTPOLY XR may cause dizziness and ataxia in patients. Advise patients not to operate machinery or motor vehicles until they know how MOTPOLY XR affects them.
  • Obtain ECG before beginning MOTPOLY XR, and after titration to steady-state maintenance dose in patients with underlying proarrhythmic conditions or those on concomitant medications that affect cardiac conduction. Closely monitor these patients.
  • MOTPOLY XR may cause syncope in patients.
  • Gradually withdraw MOTPOLY XR to minimize the potential of increased seizure frequency.
  • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/multi-organ hypersensitivity has been reported and can be life-threatening or fatal. If signs or symptoms are present, immediately evaluate the patient. Discontinue MOTPOLY XR if there is no alternative etiology.

MOST COMMON ADVERSE REACTIONS

The most common adverse reactions in adults (≥10% and greater than placebo) are diplopia, headache, dizziness, nausea, and somnolence.

PREGNANCY: Based on animal data, MOTPOLY XR may cause fetal harm.

DRUG INTERACTIONS: Consider dose reduction in patients with renal or hepatic impairment taking strong inhibitors of CYP3A4 and CYP2C9.

Please refer to the full Prescribing Information and Medication Guide for MOTPOLY XR for additional important information.

References:
1. Chung S, Ben-Menachem E, Sperling MR, et al. Examining the clinical utility of lacosamide: pooled analyses of three phase II/III clinical trials. CNS Drugs. 2010;24(12):1041-1054. 2. Wechsler RT, Li G, French J, et al. Conversion to lacosamide monotherapy in the treatment of focal epilepsy: results from a historical-controlled, multicenter, double-blind study. Epilepsia. 2014;55(7):1088-1098.

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