How does lacosamide affect fetal development?

How does lacosamide affect fetal development?

Lacosamide crosses the placenta and reaches the fetus. Animal studies show developmental toxicity at doses producing maternal plasma levels 1–2 times human exposure. These doses spawns malformations and fetal toxicity in rats and rabbits.

What do animal studies show about malformations?

In rats, lacosamide at doses 1–2 times human exposure caused cardiovascular malformations, skeletal variations, and fetal growth restriction. In rabbits, 1–2 times exposure caused fetal death, skeletal malformations, and skeletal variations. At lower doses, keine malformations appeared in either species.

Can people use lacosamide during pregnancy?

Clinical data in humans remain limited. Registries and spontaneous reports suggest a possible signal for cardiac defects and craniofacial anomalies. Registries show higher rates of major malformations when lacosamide alone or combined with other antiepileptics is used. Combined with other drugs, the risk rises further.

When does lacosamide patent expire?

Lacosamide is marketed as Vimpat by UCB. The composition-of-matter patent expired in 2021. Compound patent US 5,654,301 expires March 2025. The company has listed several method-of-use patents that延长 the exclusivity period into the 2030s.

[1] DrugPatentWatch.com