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 67th Annual Meeting of the American Epilepsy Society (AES) taking place in Washington, D.C., December 6-10, 2013.
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 frequency assessment.
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 8%), respectively.
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.i 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.ii,iii 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.iv Reducing the frequency of seizures can greatly lessen the burden of epilepsy.iv With approximately one -third of people living with epilepsy still unable to control seizures, there continues to be a need for new therapies.v
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 it is currently marketed in Europe under the trade name Zebinix®.
Please see Important Safety Information below.
Sunovion SupportTM, 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 reactions.
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 weakness.
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 balance.
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 or vomiting.
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) inhalation aerosol.
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.
©2013 Sunovion Pharmaceuticals Inc. All rights reserved.
i National Institutes of Health. “NINDS Epilepsy Information Page” Accessed 5 September 2013. <http://www.ninds.nih.gov/disorders/epilepsy/epilepsy.htm>
ii Epilepsy Foundation. “Partial Seizures.” Accessed 5 September 2013. <“http://www.epilepsyfoundation.org/aboutepilepsy/seizures/partialseizures/index.cfm>
iii Dartmouth Medical School. “Disorders of the Central Nervous System: A Primer (Chapter 22: Epilepsy).” Accessed 5 September 2013. <http://www.dartmouth.edu/~dons/part_3/chapter_22.html>
iv IOM (Institute of Medicine). 2012. Epilepsy across the spectrum: Promoting health and understanding. Washington, DC: The National Academies Press.
v Brodie MJ, Barry SJE, Bamagous GA, Norrie JD, Kwan P. Patterns of treatment response in newly diagnosed epilepsy. Neurology. 2012;78:1548-1554.