ATLANTA, Dec. 8 /PRNewswire/ -- UCB today announced new findings from analyses of pooled Vimpat(R) (lacosamide) clinical trial data, demonstrating that the new antiepileptic drug (AED) starts working during the first week of treatment and across doses in a challenging patient population, when administered as adjunctive therapy. The analyses also showed that Vimpat(R) provides consistent seizure reduction versus placebo, when added to concomitant AEDs, and that it is generally well-tolerated. These data were presented at the 62nd annual meeting of the American Epilepsy Society in Seattle.
"These data show that Vimpat(R) may help fill a considerable treatment gap as an add-on therapy for people living with epilepsy whose partial onset seizures are not controlled," said Steve Chung, director of clinical epilepsy research at Barrow Neurological Institute in Phoenix and a lead investigator for the Vimpat(R) clinical trial program. "In general, patients who participated in these trials had lived with epilepsy for an average of over 20 years and had not found seizure control despite trying multiple AEDs. Yet, Vimpat(R) provided significant seizure reduction, compared to placebo, when added to their existing treatment regimen."
The U.S. Food and Drug Administration (FDA) approved Vimpat(R) in October 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. Vimpat(R) has a novel mechanism of action that is different from all currently available AEDs. The drug will be available in U.S. pharmacies in the first quarter of 2009.
Trials Conducted in Challenging Patient Population
All four analyses evaluated pooled data from one phase II and two phase III multi-center, fixed dose, randomized, double-blind, placebo-controlled clinical trials, evaluating Vimpat(R) as adjunctive therapy. The studies and treatment arms included:
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