FDA approval was based on safety and efficacy data from three pivotal trials with approximately 1,300 patients. The study demonstrated, patients taking Vimpat had their seizures reduced to half or more and experienced reductions in median seizure frequency compared to those in the placebo group. Vimpat demonstrated efficacy and safety when combined with a broad range of existing AEDs.
Vimpat is available in 50mg, 100mg, 150mg, and 200 mg strengths and as an IV infusion.