VIMPAT (lacosamide) - New Epilepsy Treatment - Given Scottish Medicines Consortium Approval

Main Category: Epilepsy
Also Included In: Regulatory Affairs / Drug Approvals;  Neurology / Neuroscience
Article Date: 10 Feb 2009 - 5:00 PDT

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UCB's new treatment for epilepsy, has today been accepted for use in Scotland by the Scottish Medicines Consortium (SMC) for adults with partial onset seizures, as an add-on to patients' current therapy. All NHS health boards in Scotland will now consider the SMC's advice and ensure that this new treatment is made available where there is a clinical need. The SMC advise use in patients with refractory epilepsy.

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 patients with a 50% reduction in seizure frequency was 23%, 34%, and 40% for placebo, Vimpat 200 mg/day and 400 mg/day, respectively. In addition, results from an open-label extension study demonstrate long-term retention; of the 370 patients enrolled, 77% were still taking Vimpat after one year.

Between, 20,000 â€" 40,000 adults in Scotland have epilepsy. In the UK, it is estimated that around a third of people with epilepsy still experience seizures despite treatment with these medications. Epilepsy can have a huge impact on the work, social and personal lives of those with the illness, as well as their family and friends. Commenting on the SMC approval, Dr. John Paul Leach, Southern General Hospital, Glasgow said, "This acceptance by the SMC means that specialists have another therapeutic choice to offer those patients in Scotland not achieving adequate seizure control."

References

1. VIMPAT® Summary of Product Characteristics
2. Scottish Intercollegiate Guidelines Network, Royal College Physicians. Diagnosis and Management of Epilepsy in Adults. April 2003
3. Scottish Intercollegiate Guidelines Network, Royal College Physicians. Diagnosis and Management of Epilepsies in Children and Young People.March 2005
4. 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 â€" 4 Dec 2007
5. Shorvan, S. Handbook of Epilepsy Treatment. Second Edition. Blackwell Publishing 2005

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.com

Forward looking statement

This press release contains forward-looking statements based on current plans, estimates and beliefs of management. Such statements are subject to risks and uncertainties that may cause actual results to be materially different from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, effects of future judicial decisions, changes in regulation, exchange rate fluctuations and hiring and retention of its employees.

UCB, Brussels

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