Lacosamide

Neurology· 183 cited findings· 1 source document

What the regulatory reviews say

Lacosamide is an antiepileptic drug approved for the treatment of partial-onset seizures (monotherapy and adjunctive therapy) and primary generalized tonic-clonic seizures (adjunctive therapy). In the EU, it is approved for partial-onset seizures from 2 years of age and for primary generalized tonic-clonic seizures from 4 years of age. In the US, it is approved for partial-onset seizures from 1 month of age. Lacosamide is marketed in 58 countries worldwide.

Efficacy data indicate a mean (SD) reduction in seizure burden of 6.64 mins/h in the lacosamide group, compared to 2.45 mins/h in an active comparator group. The adult oral dose is 200 mg bid. The drug has a bioavailability of 0.850 fraction and a clearance of 1.63 L/h at 70kg.

Regarding safety, 15.4% of participants experienced severe treatment-emergent adverse events. The incidence rate of developmental and neurodevelopmental delay outcomes in the lacosamide cohort was 2.2 outcomes per 1000 patient days (95% CI: 1.2 to 3.7), compared to 2.0 outcomes per 1000 patient days (95% CI: 1.6 to 2.5) in the other AEDs cohort. The weighted hazard ratio for developmental or neurodevelopmental delay (lacosamide vs other AEDs) was 1.12 (95% CI: 0.55 to 2.24), with a p-value of 0.76. There were 140 postmarketing exposure cases identified for lacosamide in neonates.

Key figures — cited to the source page

Mean (SD) reduction in seizure burden (lacosamide group)	6.64	UCB SA — Lacosamide UCB EMA EPAR variation assessment report, p.7
Mean (SD) reduction in seizure burden (Active Comparator group)	2.45	UCB SA — Lacosamide UCB EMA EPAR variation assessment report, p.7
Percentage of participants experiencing severe TEAEs	15.4	UCB SA — Lacosamide UCB EMA EPAR variation assessment report, p.7
Incidence rate of developmental and neurodevelopmental delay outcomes (lacosamide cohort)	2.2	UCB SA — Lacosamide UCB EMA EPAR variation assessment report, p.6
Incidence rate of developmental and neurodevelopmental delay outcomes (other AEDs cohort)	2.0	UCB SA — Lacosamide UCB EMA EPAR variation assessment report, p.6
Weighted HR for developmental or neurodevelopmental delay (lacosamide vs other AEDs)	1.12	UCB SA — Lacosamide UCB EMA EPAR variation assessment report, p.6
Lacosamide EU approval for partial-onset seizures (monotherapy and adjunctive)	2 years	UCB SA — Lacosamide UCB EMA EPAR variation assessment report, p.5
Lacosamide US approval for partial-onset seizures	1 month	UCB SA — Lacosamide UCB EMA EPAR variation assessment report, p.5

Source documents

UCB SA — Lacosamide UCB EMA EPAR variation assessment report (EMEA/H/C/005243, 2019) (2019)

Explore the full evidence

All 183 cited findings for Lacosamide — searchable, comparable and answerable in plain language — are in the Neurology research library →

Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.