Sunovion Pharmaceuticals Inc. Presents Phase 3 Pooled Analysis of Once-Daily
Aptiom® (eslicarbazepine acetate) as Adjunctive Treatment for Partial-Onset
MARLBOROUGH, Mass. -- December 9, 2013
Sunovion Pharmaceuticals Inc. today announced results from a pooled analysis
of three Phase 3, randomized, placebo-controlled trials (Studies 301, 302 and
304) evaluating the safety and efficacy of once-daily Aptiom^®
(eslicarbazepine acetate) as adjunctive treatment of partial-onset seizures.
Key findings from the pooled Phase 3 studies showed that APTIOM demonstrated
statistically significant improvements in standardized seizure frequency for
800 mg and 1,200 mg once-daily dosages versus placebo and higher responder
rates (50% and 75% reductions) with APTIOM treatment versus placebo at the
same dosages. These results were presented at the 67^th Annual Meeting of the
American Epilepsy Society (AES) taking place in Washington, D.C., December
APTIOM was approved on November 8, 2013, by the U.S. Food and Drug
Administration (FDA) as adjunctive treatment of partial-onset seizures.
“The strong clinical evidence presented supports the use of APTIOM as an
adjunctive treatment option for people with partial-onset seizures whose
seizures are not adequately controlled with their current antiepileptic drug
treatment,” said Fred Grossman, D.O., FAPA, Senior Vice President, Clinical
Development and Medical Affairs at Sunovion. “There is a need for new
therapies since approximately one-third of people with epilepsy continue to
experience poor seizure control.”
The primary efficacy endpoint for all three Phase 3 APTIOM studies was
standardized seizure frequency per four weeks during the maintenance phase.
Secondary efficacy endpoints included relative change in seizure frequency
from baseline and responder rates (percentage of patients with ≥50% or ≥75%
seizure reduction). Safety endpoints included incidence of treatment-emergent
adverse events (TEAEs), TEAEs leading to discontinuation, serious adverse
events (SAEs) and deaths.
About the Phase 3 Studies (301, 302 and 304):
Studies 301, 302 and 304 are three Phase 3 randomized, double-blind,
placebo-controlled, safety and efficacy trials of similar study design, which
included more than 1,400 patients living with partial-onset seizures
inadequately controlled by one to three concomitant antiepileptic drugs (AEDs)
(including carbamazepine, lamotrigine, valproic acid and levetiracetam) in 35
countries, including the United States. All three trials included an 8-week
baseline period, a 2-week double-blind titration phase and a 12-week
double-blind, fixed-dose management phase. At the start of the double-blind
phase, patients were randomized and titrated to the randomized dose. Patients
were randomized equally to receive placebo or APTIOM once-daily at 400 mg
(Studies 301 and 302 only), 800 mg or 1,200 mg (all three studies). A
statistically significant effect was observed with APTIOM treatment at doses
of 800 mg once-daily in Studies 301 and 302, but not in Study 304, and at
doses of 1,200 mg once-daily in all three studies. The analyses of the pooled
data for these Phase 3 studies were based on the modified intent-to-treat
(mITT) population defined as all randomized patients who had taken at least
one dose of the study medication and had at least one post-baseline seizure
Key Findings from the Pooled Phase 3 Studies (301, 302 and 304)
*The 50% and 75% responder rates (a secondary endpoint) were 32% and 14%
for 800 mg and 41% and 16% for 1,200 mg doses compared to placebo (21% and
*The most frequent TEAEs, seen in ≥5% of patients in either APTIOM group
(800 mg or 1,200 mg) included dizziness, sleepiness (somnolence),
headache, nausea, double vision (diplopia), vomiting, fatigue, lack of
coordination (ataxia), blurred vision and vertigo.
About Partial-Onset Seizures
Epilepsy is characterized by abnormal firing of impulses from nerve cells in
the brain.^1 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.^2,3 The
unpredictable nature of seizures can have a significant impact on those with
epilepsy, affecting a number of areas of daily living, including education,
employment, driving and recreation.^4 Reducing the frequency of seizures can
greatly lessen the burden of epilepsy.^4 With approximately one -third of
people living with epilepsy still unable to control seizures, there continues
to be a need for new therapies.^5
APTIOM, a voltage-gated sodium channel inhibitor, is a prescription medicine
approved for use as adjunctive treatment of partial-onset seizures.
The initial research and development of eslicarbazepine acetate was performed
by BIAL-Portela & Ca, S.A. (BIAL), a privately held Portuguese research-based
pharmaceutical company. Subsequently, Sunovion acquired the rights under an
exclusive license to further develop and commercialize eslicarbazepine acetate
in the United States and Canadian markets from BIAL. BIAL gained approval for
eslicarbazepine acetate from the European Commission on April 21, 2009 as
adjunctive therapy in adult patients with partial-onset seizures with or
without secondary generalization and the agent is currently marketed under the
tradename Zebinix® in Europe under a license and co-promotion agreement with
Eisai Europe Limited, a European subsidiary of Eisai Co., Ltd.
Please see Important Safety Information below.
Sunovion Support™, the Sunovion patient assistance program, may help eligible
patients receive APTIOM at no charge to the patient when it becomes available.
Following the launch of APTIOM, more information on this program, including
eligibility criteria, may be found at www.SunovionSupport.com.
APTIOM (eslicarbazepine acetate) is a prescription medicine used with other
medicines to treat partial-onset seizures.
Important Safety Information
Do not take APTIOM if you are allergic to eslicarbazepine acetate, any of the
other ingredients in APTIOM or oxcarbazepine.
APTIOM may cause suicidal thoughts or actions, depression or mood problems.
Call your doctor right away if you experience these or any other effects or
APTIOM may cause serious skin rash or other serious allergic reactions, which
may affect organs or other parts of your body like the liver or blood cells.
Some symptoms may include: swelling of the face, eyes, lips or tongue, trouble
swallowing or breathing, yellowing of the skin or eyes or severe fatigue or
APTIOM may cause the level of sodium in your blood to be low. Symptoms may
include nausea, tiredness, lack of energy, irritability, confusion, muscle
weakness or muscle spasms, or more frequent or more severe seizures.
APTIOM may cause problems that can affect your nervous system including
dizziness, sleepiness, vision problems and difficulties with coordination and
APTIOM may slow your thinking or motor skills. Do not drive or operate heavy
machinery until you know how APTIOM affects you.
Do not stop taking APTIOM without first talking to your healthcare provider.
Stopping APTIOM suddenly can cause serious problems.
APTIOM may cause problems that can affect your liver. Symptoms of liver
problems include yellowing of your skin or the whites of your eyes and nausea
The most common side effects in patients taking APTIOM include dizziness,
sleepiness, nausea, headache, double vision, vomiting, feeling tired, problems
with coordination, blurred vision and shakiness.
You are encouraged to report negative side effects of prescription drugs to
the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
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.
Sunovion’s drug development program, together with its corporate development
and licensing efforts, has yielded a portfolio of pharmaceutical products
including Aptiom^® (eslicarbazepine acetate), 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 U.S. 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 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 area and the Oncology area, which have been designated as the focus
therapeutic areas. DSP is based on the merger in 2005 between Dainippon
Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, DSP
has about 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.
For a copy of this release, visit Sunovion’s web site at www.sunovion.com
©2013 Sunovion Pharmaceuticals Inc. All rights reserved.
^1 National Institutes of Health. “NINDS Epilepsy Information Page” Accessed 5
September 2013. <http://www.ninds.nih.gov/disorders/epilepsy/epilepsy.htm>
^2 Epilepsy Foundation. “Partial Seizures.” Accessed 5 September 2013.
^3 Dartmouth Medical School. “Disorders of the Central Nervous System: A
Primer (Chapter 22: Epilepsy).” Accessed 5 September 2013.
^4 IOM (Institute of Medicine). 2012. Epilepsy across the spectrum: Promoting
health and understanding. Washington, DC: The National Academies Press.
^5 Brodie MJ, Barry SJE, Bamagous GA, Norrie JD, Kwan P. Patterns of treatment
response in newly diagnosed epilepsy. Neurology. 2012;78:1548-1554.
Sunovion Pharmaceuticals Inc.
Patricia Moriarty, 508-787-4279
Senior Director, Corporate Communications
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