CPhI Online

Pipeline - Lacosamide Product Profile

18 Sep 2020

Lacosamide 10mg/ml (20ml Vial)Solution for Infusion
Reference Product: Vimpat® / UCB

Description: Lacosamide is a functionalised amino acid which belongs to the group of antiepileptics. In vitro electrophysiological studies have shown that lacosamide selectively enhances slow inactivation of voltage-gated sodium channels, resulting in stabilization of hyperexcitable neuronal membranes. 
Lacosamide is used as monotherapy and adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.
Dossier Status: On-going / EU CTD ready to file: Q2 2021
Stability Studies: Zone II / Zone IVb
Shelf life (Originator): Three (3) years
Batch Sizes: 7.766 vials
Pack Sizes: BT x 1 vial & BT x 5 vials