European Medicines Agency recommends authorisation of Vimpat syrup for patients who cannot swallow tablets

News 16/12/2011

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of a 10-mg/ml syrup of the anti-epilepsy medicine Vimpat to replace the 15-mg/ml syrup recalled earlier in the year.

Once approved by the European Commission, the 10-mg/ml syrup will provide a new treatment option that can be taken by mouth by patients who have difficulty swallowing tablets.

The recall of the 15-mg/ml syrup from the European Union market began in September 2011 after the marketing-authorisation holder, UCB Pharma SA, found uneven distribution of the active substance, lacosamide, in some bottles, putting patients at risk of inaccurate dosing. This was caused by the active substance forming a precipitate during storage.

In assessing the application, the CHMP concluded that there is no risk of the active substance precipitating in the 10-mg/ml syrup, as long as it is not refrigerated.

Vimpat has been authorised in the European Union since August 2008 for the treatment of partial-onset seizures (epileptic fits starting from one specific part of the brain) as an add-on to other anti-epileptic medicines in patients with epilepsy aged 16 years and older.

Since the recall of the 15-mg/ml syrup, the Agency has been advising doctors to switch patients to Vimpat tablets or alternative treatments, or to apply to use the 10-mg/ml syrup approved in the United States of America on a named-patient basis.

In September 2011, the CHMP recommended the removal of the formulation from Vimpat's marketing authorisation. This was endorsed by a European Commission decision on 24 November 2011.

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