UCB today announced that the
antiepileptic drug (AED) Vimpat- (lacosamide) (C-V) demonstrated significantly fewer
partial-onset seizures versus placebo in adults living with epilepsy, according to a Phase
III clinical study published online in Epilepsia.
This study was one of three that supported the approval of Vimpat by the U.S. Food and
Drug Administration (FDA) in 2008 for use as an add-on therapy for the treatment of
partial-onset seizures in people with epilepsy who are 17 years and older. Previous
studies have demonstrated that Vimpat has a novel mechanism of action. It is available
as oral tablets and as an intravenous (IV) infusion to allow for consistent treatment in a
hospital setting. Although Vimpat demonstrated clinical benefits at both doses in this
study (400 and 600 mg/day), as measured by several efficacy endpoints, the maximum
FDA-approved dose is 400 mg/day.
"This and other studies demonstrate Vimpat's established efficacy and tolerability, with
almost 3,000 patient years of exposure. In addition, no clinically significant
pharmacokinetic drug interactions were observed in clinical trials when Vimpat was used in
combination with seven different AEDs as well as several commonly used medications,"
said James Zackheim, PhD, CNS Medical Director at UCB.
Uncontrolled seizures and medication side effects pose challenges to independent living,
learning and employment, and the goal of epilepsy therapy is seizure freedom with
minimal side effects. While treatment with one drug is ideal, fewer than half (47%) of
newly-diagnosed patients become seizure-free with their first AED.
"My clinical and study experience with Vimpat reinforces its role in a new approach to
epilepsy treatment. If a monotherapy is not effective, adding another AED may help some
patients attain treatment success sooner, compared to a monotherapy-to-monotherapy
approach," said study author and lead Vimpat clinical trial investigator Steven Chung, MD,
Director of Clinical Epilepsy Research at Barrow Neurological Institute at St. Joseph's
Medical Center in Phoenix.
Vimpat Demonstrated Significant Efficacy and Greater Rates of Seizure Freedom
Versus Placebo