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UCB Announces New Data To Increase Understanding Of Short- And Long-Term Clinical Profile Of Antiepileptic Drug VIMPAT® (lacosamide)

ATLANTA, Dec. 4, 2012 /PRNewswire/ --

Data presented at the 66 th Annual Meeting of the American Epilepsy Society

  • Post hoc, population-based analysis of pivotal trials explored the efficacy of VIMPAT ® relative to placebo starting from the first week of exposure 1
  • Pooled analysis of open-label extension studies assessed the tolerability and efficacy of VIMPAT ® for a period of up to eight years among patients exposed only to approved doses 2
  • Pooled analysis of open-label extension studies evaluated the safety and efficacy of VIMPAT ® among elderly patients 3
  • Exploratory Phase II study evaluated the safety of lacosamide as adjunctive therapy for patients with primary generalized tonic-clonic seizures (PGTCS). 4 VIMPAT ® is not approved for the treatment of PGTCS.

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 66 th 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 Studies 2

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 Week 1

This post hoc analysis of pooled data from three randomized, double-blind, placebo-controlled Phase II/III trials studied lacosamide's efficacy starting from the first week of exposure (100 mg/day).  Data from 935 patients with long-standing epilepsy (mean time since diagnosis of >20 years) with a median baseline seizure frequency per 28 days of 11.5 seizures were included in the analysis. All patients in the exposure group received 100 mg/day of lacosamide during the first week, followed by weekly titration of 100 mg increments to three levels of exposure: 200 mg/day, 400 mg/day and 600mg/day. The maximum approved daily dose for lacosamide in the European Union and the U.S. is 400 mg/day.

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