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Patients who Added Vimpat to Their Treatment Plan Experienced Fewer Seizures

In the double-blind, placebo-controlled Phase III study, patients began experiencing a reduction in seizures during the titration period and maintained or improved seizure control throughout the study. Vimpat significantly reduced seizure frequency per 28 days from baseline versus placebo (20.5 percent for placebo, 35.3 percent for Vimpat 200 mg/day [P=0.02], and 36.4 percent for Vimpat 400 mg/day [P=0.03]).

In addition, a higher rate of patients experienced a 50 percent or greater reduction in seizure frequency. Significantly more patients responded to Vimpat 400 mg/day than placebo (40.5 percent had seizures reduced by at least half versus 25.8 percent, respectively [P=0.01]), and numerically more patients responded to Vimpat 200 mg/day than placebo (35.0 percent had seizures reduced by at least half versus 25.8 percent, respectively [P=0.07]).

Vimpat patients who completed the maintenance phase of the study also experienced more complete seizure freedom than those in the placebo group. Among patients taking Vimpat 200 mg/day and 400 mg/day, 3.6 percent and 2.4 percent, respectively, were seizure-free throughout the maintenance phase, compared to 2.1 percent of patients in the placebo group.

In the study, the most commonly reported treatment-emergent adverse events were dizziness (4.9 percent for placebo, 10.4 percent for Vimpat 200 mg/day and 15.7 percent for Vimpat 400 mg/day), headache (7.4 percent, 11.0 percent and 8.2 percent, respectively) and diplopia (1.2 percent, 8.0 percent and 10.1 percent, respectively). Most adverse events were mild to moderate in intensity. These data are consistent with results from other clinical trials of Vimpat.

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