Vimpat(R) (lacosamide) C-V, A New Antiepileptic Drug (AED), To Be Available In U.S. Pharmacies

Main Category: Epilepsy
Also Included In: Regulatory Affairs / Drug Approvals;  Pharmacy / Pharmacist;  Clinical Trials / Drug Trials
Article Date: 27 May 2009 - 2:00 PDT

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Vimpat(R) (lacosamide) C-V, a new antiepileptic drug (AED), will be available in U.S. pharmacies by the first week of June 2009. Vimpat was approved by the U.S. FDA in the fall of 2008 for the use as an add-on therapy for the treatment of partial-onset seizures in people 17 years and older with epilepsy.

Vimpat approval is based on safety and efficacy data from three pivotal trials with approximately 1,300 patients. In the studies, many patients taking Vimpat had their seizures reduced by half or more and experienced reductions in median seizure frequency at rates that were significantly greater than those in the placebo group. Across the pivotal trials, 2.7% of the patients taking 200 mg/day and 3.3% of patients taking 400 mg/day of Vimpat were seizure free throughout the 12-week maintenance phase, vs. 0.9% of placebo patients.

Vimpat demonstrated efficacy and safety when combined with a broad range of existing AEDs.

Vimpat is available in 50, 100, 150, and 200 mg strengths, and as an IV infusion. Formulations can be used interchangeably at equivalent dosing. Vimpat should be taken twice daily; the daily dose should not exceed 400 mg.

In clinical trials, treatment-related adverse events were mostly characterized as "mild" or "moderate" in severity and included dizziness, headache, diplopia, and nausea.

Epilepsy is a chronic neurological disorder affecting approximately three million people in the U.S.

-- Epilepsy can affect anyone at any time; it is a common neurological condition that can be life long

-- Less than half (47%) will attain seizure control with the first AED

-- More than 30% will continue to experience seizures despite trying two or more AEDs

-- 200,000 new cases are diagnosed each year, a number that is expected to grow at a faster rate as the population ages

Important safety information about Vimpat in the U.S.

Vimpat tablets are indicated as adjunctive therapy in the treatment of partial-onset seizures in patients with epilepsy who are 17 years and older. Vimpat injection is indicated as short-term replacement when oral administration is not feasible in these patients. 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. Multiorgan hypersensitivity reactions have been reported with antiepileptic drugs. If this reaction is suspected, treatment with Vimpat should be discontinued.

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.

The most common adverse reactions occurring in greater than or equal to 10 percent of Vimpat-treated patients, and greater than placebo, were dizziness, headache, nausea, and diplopia.

Vimpat(R) is a registered trademark under license from Harris FRC Corporation.

About UCB

UCB, Brussels, Belgium is a biopharmaceutical company dedicated to the research, development and commercialization of innovative medicines with a focus on the fields of central nervous system and immunology disorders. Employing more than 10,000 people in over 40 countries, UCB achieved revenue of 3.6 billion Euro in 2008. UCB is listed on Euronext Brussels (symbol: UCB).

Forward looking statement

This press release contains forward-looking statements based on current plans, estimates and beliefs of management. Such statements are subject to risks and uncertainties that may cause actual results to be materially different from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, effects of future judicial decisions, changes in regulation, exchange rate fluctuations and hiring and retention of its employees.

Source: UCB