Vimpat(R) (lacosamide) C-V, a New Antiepileptic Drug (AED), To Be Available in U.S. ... ( ATLANTA May 26 /- Vimpat (R) (lacosa...)

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

Date:5/26/2009

ATLANTA, May 26 /PRNewswire/ -- 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.

(Photo: http://www.newscom.com/cgi-bin/prnh/20090526/NY22555 )

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% wi
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Vimpat(R) (lacosamide) C-V, a New Antiepileptic Drug (AED), To Be Available in U.S. ...( ATLANTA May 26 /- Vimpat (R) (lacosa...)