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US FDA accepts Sunovion's resubmitted NDA for Stedesa for review

Marlborough, MassachusettsFriday, March 1, 2013, 14:00 Hrs  [IST]

The US Food and Drug Administration (FDA) has accepted for review Sunovion Pharmaceuticals Inc.’s New Drug Application (NDA) resubmission for Stedesa (eslicarbazepine acetate) for use as a once-daily adjunctive therapy in the treatment of partial-onset seizures in patients 18 years and older with epilepsy.

“We are pleased to achieve this regulatory milestone for Stedesa, which, if approved, may offer adult patients living with epilepsy an effective, once-daily, adjunctive treatment option for managing partialonset seizures,” said Fred Grossman, D.O., FAPA, senior vice president, clinical development and medical affairs at Sunovion. “Adequate seizure control of this most common form of epilepsy remains an unmet medical need for a significant number of patients and Sunovion is committed to providing a treatment option to help address this need.”

The NDA for Stedesa is supported by data from three phase III randomized, double-blind, placebocontrolled 12-week maintenance trials of similar study design, which included more than 1,300 patients with partial-onset seizures in 35 countries, including the United States. Treatment with Stedesa demonstrated statistically significant reductions in standardized seizure frequency when used as adjunctive therapy. The most commonly reported adverse events in the clinical trials were dizziness, somnolence, headache, nausea, diplopia, vomiting, fatigue, ataxia, vision blurred, and vertigo.

The original NDA was submitted to the FDA in March 2009. This resubmission was prepared by Sunovion following receipt of the FDA’s April 2010 Complete Response Letter and subsequent correspondence requesting additional information. Eslicarbazepine acetate is currently marketed in Europe by BIALPortela & Cª, S.A and by BIAL´s licensee, Eisai Europe Limited, a UK subsidiary of Eisai Co., Ltd. under the trade name Zebinix. Zebinix was approved by the European Commission on April 21, 2009 as adjunctive therapy in adult patients with partial-onset seizures with or without secondary generalization.

Sunovion and BIAL are also conducting clinical trials to evaluate eslicarbazepine acetate as monotherapy in the treatment of partial-onset seizures in adult patients with epilepsy.

Epilepsy is one of the most common neurological disorders and, according to the Centers for Disease Control and Prevention, affects nearly 2.2 million people in the United States. It is characterized by abnormal firing of impulses from nerve cells in the brain.

Stedesa (eslicarbazepine acetate) is an investigational voltage-gated sodium and T-type calcium  channel blocker that has been evaluated in three Phase III clinical trials involving more than 1,300 patients with partial-onset epilepsy worldwide.  BIAL-Portela & Cª, S.A., a privately held Portuguese research based pharmaceutical company, was responsible for the initial research and development of eslicarbazepine acetate. In late 2007, Sunovion Pharmaceuticals Inc., formerly known as Sepracor Inc., acquired the rights to further develop and commercialize eslicarbazepine acetate in the US and Canadian markets from BIAL.

Sunovion is a leading pharmaceutical company dedicated to discovering, developing and commercializing therapeutic products that advance the science of medicine in the psychiatry & neurology and respiratory disease areas and improve the lives of patients and their families.

DSP is a multi-billion dollar, top-ten listed pharmaceutical company in Japan with a diverse portfolio of pharmaceutical, animal health and food and specialty products.

 
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