FDA Reviews Vimpat as Monotherapy in Partial-Onset Seizures
UCB announced that the FDA has accepted for filing a supplemental New Drug Application (sNDA) for Vimpat (lacosamide) C-V as monotherapy in the treatment of partial-onset seizures in patients with epilepsy ≥17 years of age.
The sNDA filing was supported by investigational data from a Phase 3, international, historical-controlled, multicenter, double-blind, randomized lacosamide conversion to monotherapy study in adults with partial-onset seizures.
Data showed that the study met its primary endpoint demonstrating that the predicted exit rate for patients converting to lacosamide 400mg/day (0.300: 95% CI [0.246, 0.355]) was significantly lower than the historical control exit rate, used as a comparator (0.653). In the study, a lacosamide 300mg/day arm was added to blind the treatment group and to ensure a study design consistent with the historical control studies
Vimpat is already approved as adjunctive therapy for the treatment of partial-onset seizures in patients with epilepsy ≥17 years of age. Vimpat is available as tablets, IV injection, and oral solution.For more information call (800) 477-7877 or visit Vimpat.com.