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Interim results of VITOBA™ (VImpaT® added to One Baseline AED) Study Presented at the 64th Annual Meeting of the American Academy of Neurology
Date:4/26/2012

eater than or equal to 10 percent of Vimpat® -treated patients, and greater than placebo, were dizziness, headache, nausea and diplopia.  Additional important safety information for Vimpat® is available at the end of the press release.

In the European Union, Vimpat® (film-coated tablets and solution for infusion) is approved as adjunctive therapy for the treatment of partial-onset seizures with or without secondary generalization in patients with epilepsy, aged 16 years and older.  Vimpat® solution for infusion may be used when oral administration is temporarily not feasible.

The maximum recommended daily dose for Vimpat® in the European Union and the U.S. is 400 mg/day.

Important safety information about Vimpat® in the U.S.

Warnings and Precautions
AEDs increase the risk of suicidal behavior and ideation. Patients taking Vimpat® should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

Patients should be advised that Vimpat® may cause dizziness, ataxia, and syncope. Caution is advised for patients with known cardiac conduction problems, who are taking drugs known to induce PR interval prolongation, or with severe cardiac disease. In patients with seizure disorders, Vimpat® should be gradually withdrawn to minimize the potential of increased seizure frequency. Multi-organ hypersensitivity reactions have been reported with antiepileptic drugs. If this reaction is suspected, treatment with Vimpat® should be discontinued.

Vimpat® oral solution contains aspartame, a source of phenylalanine. A 200 mg dose of Vimpat® oral solution (equivalent to 20 mL) contains 0.32 mg of phenylalanine.

Common Adverse Reactions
The most common adverse reactions occurring in greater than or equal to 10 percent of Vimpat®-t
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