Sepracor announces new drug submission to Health Canada for seizure drug

Sepracor has announced that its Canadian subsidiary, Sepracor Pharmaceuticals, has submitted an application to the Therapeutic Products Directorate of Health Canada for eslicarbazepine acetate as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy. The proposed trade name for eslicarbazepine acetate in both the US and Canada is Stedesa.

Stedesa, a new chemical entity, is a novel voltage-gated sodium channel blocker that has been designed to reduce the frequency of partial-onset seizures. Under Health Canada's Food and Drugs Act and Regulations, the Therapeutic Products Directorate has 45 days in which to screen the submission to determine whether it is complete and of suitable quality to be reviewed.

Sepracor submitted its new drug application (NDA) for Stedesa to the FDA in March 2009 for adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy, and the FDA accepted the filing for formal review in June 2009. The Prescription Drug User Fee Act (PDUFA) action date for Stedesa in the US is January 30, 2010. A PDUFA date is the date by which the FDA is expected to review and act on an NDA submission.

Sepracor is seeking approval of Stedesa in the US and Canada for adjunctive therapy with once-daily maintenance doses of 800mg and 1200mg in the treatment of partial-onset seizures in adults with epilepsy.

Douglas Reynolds, president of Sepracor Pharmaceuticals, said: "The Stedesa submission represents Sepracor Pharmaceuticals's continuing commitment to providing Canadians with important new therapies in the treatment of central nervous system disorders, which is a therapeutic area in which we already have commercial experience. If approved by Health Canada, Stedesa has the near-term potential to be an important new treatment option for patients suffering with epilepsy."

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