Sunovion Reports Eslicarbazepine Acetate Meets Primary Endpoint in Two Phase
3 Monotherapy Studies for Partial-onset Seizures in Adults with Epilepsy
MARLBOROUGH, Mass. -- September 17, 2013
Sunovion Pharmaceuticals Inc. (Sunovion) today announced that two completed
Phase 3 trials of eslicarbazepine acetate (ESL) as a monotherapy treatment
(Studies 093-045 and 093-046) met their primary endpoint. ESL was
well-tolerated and demonstrated seizure control rates superior to historical
controls in adult patients with partial-onset seizures with or without
secondary generalization who were not well-controlled by current antiepileptic
drugs (AEDs). ESL is an investigational AED currently under review by the U.S.
Food and Drug Administration (FDA) for use as a once-daily adjunctive therapy
in the treatment of partial-onset seizures in patients 18 years and older with
epilepsy. The efficacy and safety of ESL as an adjunctive or monotherapy
treatment for partial-onset seizures in adults living with epilepsy has not
yet been established.
“We are pleased to achieve this important milestone in monotherapy, which
builds upon our existing data in adjunctive therapy for patients suffering
from partial-onset seizures,” said Fred Grossman, D.O., FAPA, Senior Vice
President, Clinical Development and Medical Affairs at Sunovion. “Pending the
outcome of FDA review of the current New Drug Application (NDA) resubmission
for eslicarbazepine acetate as an adjunctive treatment, Sunovion plans to
submit these data as part of a supplemental NDA in support of a monotherapy
Detailed results from Studies 093-045 and 093-046 will be presented at
upcoming scientific meetings.
The objective of the studies was to evaluate the efficacy and safety of ESL as
a monotherapy for treating partial-onset seizures in adults who were not
well-controlled by current AEDs. Studies 093-045 and 093-046 were two Phase 3,
double-blind, historical-controlled, multicenter randomized trials with
identical study designs, which evaluated ESL monotherapy for treating
partial-onset seizures in adult patients living with epilepsy. Study 093-045
included 193 patients from 67 study centers across North America. Study
093-046, a global study, included 172 patients across 41 study centers in five
The primary endpoint for both studies was the proportion of patients meeting
pre-defined exit criteria (signifying worsening seizure control) 16 weeks
post-titration in comparison to historical controls. In both studies, adult
patients who were not well-controlled (≥ four partial-onset seizures in the
eight weeks prior to screening and no four week seizure-free period) with one
to two AEDs were gradually converted to monotherapy treatment with ESL and
randomized 1:2 to receive ESL 1,200mg QD (n=65 in Study 093-045; n=58 in Study
093-046) or ESL 1,600mg QD (n=128 in Study 093-045; n=114 in Study 093-046).
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.^i It is characterized by abnormal firing of
impulses from nerve cells in the brain.^ii 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
affected areas.^iii, iv
ESL is an investigational voltage-gated sodium and T-type calcium channel
blocker that has been evaluated in three Phase 3 clinical trials involving
more than 1,400 patients with partial-onset seizures worldwide. The initial
research and development of ESL was performed by BIAL-Portela & C^a, S.A., a
privately held Portuguese research based pharmaceutical company. Subsequently,
Sunovion Pharmaceuticals Inc., acquired the rights to further develop and
commercialize ESL in the U.S. and Canadian markets from BIAL. In February
2009, Eisai Europe Limited, a European subsidiary of Eisai Co., Ltd., entered
into a license and co-promotion agreement with BIAL, which gave the rights to
the former to sell ESL 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
and is currently marketed in Europe under the agreement.
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)
Dainippon Sumitomo Pharma Co., Ltd. (DSP) is a 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.
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.
^i IOM (Institute of Medicine). 2012. Epilepsy across the spectrum: Promoting
health and understanding. Washington, DC: The National Academies Press.
^ii National Institutes of Health. “NINDS Epilepsy Information Page” Accessed
5 September 2013. <http://www.ninds.nih.gov/disorders/epilepsy/epilepsy.htm>
^iii Epilepsy Foundation. “Partial Seizures.” Accessed 5 September 2013.
^iv Dartmouth Medical School. “Disorders of the Central Nervous System: A
Primer (Chapter 22: Epilepsy).” Accessed 5 September 2013.
Sunovion Pharmaceuticals Inc.
Patricia Moriarty, 508-787-4279
Senior Director, Corporate Communications
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