Sepracor Inc announced that its Canadian subsidiary, Sepracor Pharmaceuticals, Inc, has submitted an application to the Therapeutic Products Directorate (TPD) 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.

"The Stedesa submission represents SPI'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," said Douglas Reynolds, president of Sepracor Pharma, Inc. "If approved by Health Canada, Stedesa has the near-term potential to be an important new treatment option for patients suffering with epilepsy."

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.

"This NDS is our first submission in Canada since our strategic acquisition of Oryx Pharmaceuticals in June of last year, and we are very pleased to take this important step in what we hope to be the first of several submissions to Health Canada in the coming years," said Adrian Adams, president and chief executive officer of Sepracor. "This advancement follows our recent New Drug Application submission for Stedesa in the United States and is a manifestation of the value of the successful corporate development and licensing initiatives that Sepracor has executed to date."

Under Health Canada's Food and Drugs Act and Regulations, the TPD 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 NDA for Stedesa to the US Food and Drug Administration (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.

BIAL-Portela & Ca, SA (BIAL), a privately held Portuguese pharmaceutical company, was responsible for the research and development of eslicarbazepine acetate. Sepracor acquired the rights to commercialize eslicarbazepine acetate for the US and Canadian markets from BIAL in late 2007.

Stedesa has been studied in three phase-III, multi-center, randomized, placebo-controlled trials, which involved more than 1,000 patients from 23 countries.

Sepracor is a research-based pharmaceutical company dedicated to treating and preventing human disease by discovering, developing and commercializing innovative pharmaceutical products that are directed toward serving large and growing markets and unmet medical needs.