Sunovion Announces FDA Acceptance for Review of New Drug Application
Resubmission for STEDESA® (eslicarbazepine acetate) as a Once-Daily
Adjunctive Therapy for Partial-onset Seizures in Adults with Epilepsy
MARLBOROUGH, Mass. -- February 27, 2013
Sunovion Pharmaceuticals Inc. (Sunovion) today announced that the U.S. Food
and Drug Administration (FDA) has accepted for review the Company’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. STEDESA^® is the proposed trade
name for eslicarbazepine acetate.
“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 partial-onset 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, placebo-controlled 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
BIAL-Portela & 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
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.
About Partial-onset Seizures
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.^1 It is characterized by abnormal firing of
impulses from nerve cells in the brain.^2 In partial-onset seizures, these
bursts of electrical activity are initially focused in specific areas of the
brain, but may become more widespread, with symptoms varying according to the
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 U.S. and Canadian markets
About Sunovion Pharmaceuticals Inc. (Sunovion)
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. Sunovion’s drug development
program, together with its corporate development and licensing efforts, has
yielded a portfolio of pharmaceutical products including LATUDA^® (lurasidone
HCl) tablets, LUNESTA^® (eszopiclone) tablets, XOPENEX^® (levalbuterol HCI)
inhalation solution, XOPENEX HFA^® (levalbuterol tartrate) inhalation aerosol,
BROVANA^® (arformoterol tartrate) inhalation solution, OMNARIS^® (ciclesonide)
nasal spray, ZETONNA^® (ciclesonide) nasal aerosol and ALVESCO^® (ciclesonide)
Sunovion, an indirect, wholly-owned subsidiary of Dainippon Sumitomo Pharma
Co., Ltd., is headquartered in Marlborough, Mass. More information about
Sunovion Pharmaceuticals Inc. is available at www.sunovion.com.
About Dainippon Sumitomo Pharma Co., Ltd. (DSP)
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. DSP aims to produce innovative pharmaceutical products in
the Psychiatry & Neurology field, which has been designated as one of the two
key therapeutic areas. DSP is based on the merger in 2005 between Dainippon
Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, DSP
has more than 7,000 employees worldwide. Additional information about DSP is
available through its corporate website at www.ds-pharma.com.
LATUDA ^ is a registered trademark of Dainippon Sumitomo Pharma Co., Ltd.
LUNESTA, XOPENEX, XOPENEX HFA, and BROVANA are registered trademarks of
Sunovion Pharmaceuticals Inc. OMNARIS and ALVESCO are registered trademarks of
Takeda GmbH, used under license. STEDESA is a registered trademark of Bial -
Portela & Cª, S.A., used under license.
Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Dainippon Sumitomo
Pharma Co., Ltd. ^© 2013 Sunovion Pharmaceuticals Inc.
For a copy of this release, visit Sunovion’s web site at www.sunovion.com
©2013 Sunovion Pharmaceuticals Inc. All rights reserved
^1 IOM (Institute of Medicine). 2012. Epilepsy across the spectrum: Promoting
health and understanding. Washington, DC: The National Academies Press.
Sunovion Pharmaceuticals Inc.
Patricia Moriarty, 508-787-4279
Senior Director, Corporate Communications
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