VIMPAT (lacosamide), A New Epilepsy Treatment For Adults With Partial Onset Seizures, Launched In The UK

Main Category: Epilepsy
Article Date: 14 Oct 2008 - 6:00 PDT

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Vimpat (lacosamide), a new adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older, has been launched in the UK.

The efficacy of VIMPAT® as adjunctive therapy at recommended doses (200 mg/day, 400 mg/day) was established in 3 multicentre, randomised, placebo-controlled clinical trials with a 12-week maintenance period. Overall the proportion of subjects with a 50% reduction in seizure frequency was 23%, 34%, and 40% for placebo, lacosamide 200 mg/day and lacosamide 400 mg/day, respectively. In addition, results from an open-label extension study demonstrate long-term retention on Vimpat. Of the 370 patients enrolled in the study, 77% were still taking Vimpat after one year.

Over 450,000 people in the UK have epilepsy, but despite current therapy it is estimated that around one third of patients still experience seizures. Commenting on the launch, Professor Ley Sander said, "For the many patients not achieving adequate seizure control, epilepsy can have a serious affect on social, work and personal life. It is excellent news that we now have another therapeutic choice, which has been shown to be effective in a significant proportion of patients."

Adverse events are common with adjunctive anti-epilepsy drugs (AEDs). Lacosamide was generally well tolerated when added to a broad range of AEDs, with no clinically relevant drug-to-drug interactions seen with the most commonly used AEDs.

The most frequently reported adverse reactions with lacosamide treatment were dizziness, headache, nausea and diplopia. They were usually mild to moderate in intensity. Some were dose-related and could be alleviated by reducing the dose. Incidence and severity of CNS and gastrointestinal (GI) adverse reactions usually decreased over time.

Prolongations in PR interval with lacosamide have been observed in clinical studies. Lacosamide should be used with caution in patients with known conduction problems or severe cardiac disease such as a history of myocardial infarction or heart failure. Caution should especially be exerted when treating elderly patients as they may be at an increased risk of cardiac disorders or when lacosamide is used in combination with products known to be associated with PR prolongation.

Vimpat has an innovative mode of action differentiating it from other available AEDs. The precise mechanism by which lacosamide exerts its antiepileptic effect in humans remains to be fully elucidated, but two observations that may be of relevance for the observed therapeutic effects are:

In vitro electrophysiological studies have shown that lacosamide selectively enhances slow inactivation of voltage-gated sodium channels, resulting in stabilization of hyperexcitable neuronal membranes.

Further, lacosamide binds to collapsin response mediator protein 2 (CRMP 2), a phosphoprotein which is mainly expressed in the nervous system and is involved in neuronal differentiation and control of axonal outgrowth.

References

1 - VIMPAT® Summary of Product Characteristics

2 - Rosenfeld W et al Lacosamide: An Interim Evaluation of Long-term Safety and Efficacy as Oral Adjunctive Therapy in Subjects with Partial Onset Seizures. 61st Annual American Epilepsy Meeting 30 Nov - 4 Dec 2007

3 - National Society for Epilepsy. Epilepsy: Information on epileptic seizures.Available at: http://www.epilepsynse.org.uk/PAGES/whatsnew/pr/ep_facts.cfm [Accessed 15 August 2008]

4 - Shorvan, S. Handbook of Epilepsy Treatment. Second Edition. Blackwell Publishing 2005

5 - Ben-Menachem, E. Lacosamide: an investigational drug for adjunctive treatment of partial-onset seizures. Drugs of Today 2007; 43 Available at: www.prous.com/journals

Additional information

-- VIMPAT (lacosamide) is a new antiepileptic drug approved in the UK as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older.

-- The recommended VIMPAT doses are 200 mg/day and 400 mg/day. The maximum recommended dose for VIMPAT is 400 mg/day.

-- The key clinical trials, involving 1308 patients with a history of an average of 23 years of partial-onset seizures, were designed to evaluate the efficacy and safety of lacosamide when administered concomitantly with 1 3 antiepileptic drugs in patients with uncontrolled partial-onset seizures with or without secondary generalisation.

-- Strong enzyme inducers such as rifampicin or St John´s wort (Hypericum perforatum) may moderately reduce the systemic exposure of lacosamide. Therefore, starting or ending treatment with these enzyme inducers should be done with caution

-- Based on the analysis of pooled placebo-controlled clinical trials in 1,308 patients with partial-onset seizures, a total of 61.9% of patients randomized to lacosamide and 35.2% of patients randomized to placebo reported at least 1 adverse reaction.

-- -- Adverse Reactions: the most frequently reported adverse reactions with Vimpat treatment were dizziness, headache, nausea and diplopia (double vision). They were usually mild to moderate in intensity and some were dose-related and could be alleviated by reducing the dose. Incidence and severity of CNS and gastrointestinal (GI) adverse reactions decreased over time.

About UCB

UCB, Brussels, Belgium is a global leader in the biopharmaceutical industry dedicated to the research, development and commercialisation of innovative medicines with focus on the fields of central nervous system and immunology disorders. Employing around 12 000 people in over 40 countries, UCB achieved revenue of 3.6 billion euro in 2007. UCB is listed on Euronext Brussels (symbol: UCB). http://www.ucb-group.com

Forward looking statement
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