UCB announced that the Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Vimpat (lacosamide) as monotherapy in the treatment of partial-onset seizures in patients with epilepsy aged ≥17 years. Vimpat, a Schedule IV sodium channel inactivator, is already approved as adjunct therapy in partial-onset seizures.
The new approval was based on a Phase 3 multicenter, randomized, historical-control conversion to lacosamide monotherapy study in adults with partial-onset seizures. The study’s primary endpoint was met, showing that the exit percentage (estimated percentage of patients meeting pre-defined exit criteria for those converting to lacosamide 400mg daily) was significantly lower than the historical control exit percentage. Lacosamide 300mg daily also met the pre-specified efficacy criteria.
Vimpat is available in 50mg, 100mg,150mg, and 200mg strength tablets in 60-count bottles; as a 200mg/20mL single-use vial for intravenous (IV) use in 10-count cartons; and as a 10mg/mL oral solution in 200mL and 465mL bottles.
For more information call (844) 599-2273 or visit Vimpat.com.