ATLANTA, Dec. 4, 2012 /PRNewswire/ --
Data presented at the 66th Annual Meeting of the American Epilepsy Society
UCB today announced research evaluating safety and efficacy of VIMPAT (lacosamide) C-V in adults with partial-onset seizures (POS) and in other special populations. An additional study offered preliminary insight into the antiepileptic drug's (AED) safety as adjunctive therapy for patients with primary generalized tonic-clonic seizures (PGTCS). These and other VIMPAT data were presented at the 66th Annual Meeting of the American Epilepsy Society (AES) in San Diego, Calif., November 30 - December 4.
"As researchers, our commitment to ongoing clinical investigation of medicines is driven by patient needs," said Dr. William Rosenfeld, M.D., Director, The Comprehensive Epilepsy Care Center for Children and Adults, St. Louis, Mo. "By better understanding the short-term and long-term profile of VIMPAT in a variety of patient populations and settings, we can identify appropriate treatment options for patients with epilepsy and where further research is warranted."
VIMPAT is indicated as adjunctive therapy for the treatment of partial-onset seizures in adults with epilepsy (ages> 17 years in the U.S., ages> 16 years in the EU). VIMPAT is not approved for the treatment of PGTCS. The most common adverse reactions reported in pivotal trials and occurring in 10 percent or more of VIMPAT-treated patients, and greater than placebo, were dizziness, headache, nausea, and diplopia. Additional important safety information for VIMPAT is available below.
Summary of Lacosamide Data Presented at AES:
Abstract: 1.227 Long-Term Treatment of Partial-Onset Seizures in Adults Exposed Only to Approved Lacosamide Doses: Pooled Analysis of Three Open-label Extension Studies2
This sub-group analysis of pooled data from three long-term open-label extension trials studied the long-term tolerability and efficacy of adjunctive lacosamide for up to eight years. Of the 1054 patients who completed a phase II or III trial and entered the open label trials, 363 patients were treated within the approved dose range (<400 mg/day).
Among those patients, the safety profile of lacosamide was consistent with the findings observed in the controlled clinical trials. The most commonly reported treatment-emergent adverse events (>10%) were dizziness (21.5%), headache (14%), and nasopharyngitis (10.7%). Lacosamide exposure was associated with a reduction in seizure frequency during the study period. Further studies are warranted.
Abstract: 3.250 Early Efficacy with Adjunctive Lacosamide Treatment in Patients with Uncontrolled Partial Seizures: Analysis of Mean Percentage of Seizure-Free Days Per Week1