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Sunovion to Initiate Recruitment for Aptiom® (eslicarbazepine acetate) Clinical Study with Integrated Digital Health Technology to Aid Seizure Detection

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MARLBOROUGH, Mass.--(BUSINESS WIRE)--

Sunovion Pharmaceuticals Inc. (Sunovion) announced today plans to initiate enrollment for a Phase 4 clinical study (Study 093-701) of Aptiom® (eslicarbazepine acetate). The clinical study will include the use of the Embrace watch by Empatica, an investigational wearable device with unique proprietary technology that will be used to detect and record partial-onset seizures subjectively identified by patients or caregivers. This is the first time that a wearable seizure detection device has been incorporated into the trial design of an anti-epileptic drug (AED) for partial-onset seizures such as APTIOM.

This study is designed to obtain data in real-world clinical settings supporting the use of APTIOM as adjunctive therapy for partial-onset seizures. APTIOM is approved in the U.S. for partial-onset seizures as monotherapy or adjunctive therapy.

"We believe that incorporating digital health technologies into traditional treatment paradigms has the potential to inform and enhance best practices and further empower people living with serious medical conditions and their families," said Antony Loebel, M.D., Executive Vice President and Chief Medical Officer, Sunovion. "We look forward to sharing the results of this study and continue to look for opportunities for Sunovion to leverage advances in digital health."

Study 093-701 is a multicenter, open-label, non-randomized Phase 4 trial of APTIOM with two treatment groups, which will enroll approximately 190 adults with partial-onset seizures. The study will evaluate the outcomes among patients with uncontrolled partial-onset seizures taking APTIOM, as either first add-on therapy to levetiracetam or lamotrigine monotherapy or as later add-on to AEDs for participants who have previously been treated with another add-on therapy.

The first treatment group will receive APTIOM as first add-on therapy following failure of monotherapy with either lamotrigine or levetiracetam. The second treatment group will receive APTIOM as later add-on therapy for patients with treatment-resistant epilepsy requiring additional therapeutic options. The primary endpoint is the proportion of patients completing 24 weeks of treatment. Impact on seizure frequency (both subjective and objective), safety, mood and quality of life measures will also be evaluated during the study.

Information about this study relevant to the recruitment of potential investigators will be available at the Sunovion Scientific Exhibit at the 70th Annual Meeting of the American Epileptic Society (AES) taking place December 2-6 in Houston, Texas.

About Aptiom® (eslicarbazepine acetate)

APTIOM is the latest member of the dibenzazepine carboxamide family of antiepileptic drugs (AEDs), an established class of medicines. APTIOM is the only exclusively once-daily, non-extended release AED FDA-approved for use as monotherapy or adjunctive therapy for partial-onset seizures. The precise mechanism(s) by which eslicarbazepine, the primary active metabolite of APTIOM, exerts anticonvulsant activity is unknown but is thought to involve inhibition of voltage-gated sodium channels. APTIOM can be taken whole or crushed, with or without food. APTIOM is not classified as a controlled substance by the FDA.

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 Canada markets from BIAL. BIAL gained approval for eslicarbazepine acetate from the European Medicines Agency on April 21, 2009 as adjunctive therapy in adult patients with partial-onset seizures with or without secondary generalization. In Europe, the product is marketed under the trade name Zebinix®. APTIOM is approved in Canada for use as adjunctive therapy in the treatment of partial-onset seizures in patients with epilepsy who are not satisfactorily controlled with conventional therapy.

About Epilepsy and Partial-Onset Seizures

Epilepsy is the fourth most common neurological condition, and one in 26 people in the U.S. will develop epilepsy in his or her lifetime.i Epilepsy manifests as unprovoked seizures, which are caused by abnormal firing of impulses from nerve cells in the brain.ii Partial-onset seizures, the most common type of seizure, are characterized by bursts of electrical activity that are initially focused in specific areas of the brain and may become more widespread, with symptoms varying according to the affected areas.iii The unpredictable nature of seizures may have a significant impact on those with epilepsy. Reducing the frequency of seizures may lessen the burden of epilepsy. With approximately one-third of people living with epilepsy still unable to control seizures, there continues to be a need for new therapies.iv Up to 40 percent of people living with epilepsy do not respond to the first or second monotherapy,v and approximately 36 percent fail to achieve adequate control of seizures despite the use of two or more antiepileptic medications.vi

Please see Important Safety Information below.

INDICATION:

Aptiom® (eslicarbazepine acetate) is a prescription medicine used alone or 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.

Suicidal behavior and ideation: Antiepileptic drugs, including APTIOM, may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call your doctor right away if you have any of the following symptoms, especially if they are new, worse or worry you: thoughts about suicide or dying; attempting to commit suicide; new or worse depression, anxiety, or irritability; feeling agitated or restless; panic attacks; trouble sleeping (insomnia); acting aggressive; being angry or violent; acting on dangerous impulses; an extreme increase in activity and talking (mania); or other unusual changes in behavior or mood.

Allergic reactions: APTIOM may cause serious skin rash or other serious allergic reactions that may affect organs or other parts of your body like the liver or blood cells. You may or may not have a rash with these types of reactions. Call your doctor right away if you experience any of the following symptoms: swelling of the face, eyes, lips, or tongue; trouble swallowing or breathing; hives; fever, swollen glands, or sore throat that do not go away or come and go; painful sores in the mouth or around your eyes; yellowing of the skin or eyes; unusual bruising or bleeding; severe fatigue or weakness; severe muscle pain; or frequent infections or infections that do not go away.

Low salt (sodium) levels in the blood: 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. Some medicines can also cause low sodium in your blood. Be sure to tell your health care provider about all the other medicines that you are taking.

Nervous system problems: APTIOM may cause problems that can affect your nervous system, including dizziness, sleepiness, vision problems, trouble concentrating, 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.

Liver 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, nausea or vomiting, loss of appetite, stomach pain, or dark urine.

Most common adverse reactions: 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.

Drug interactions: Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking APTIOM with certain other medicines may cause side effects or affect how well they work. Do not start or stop other medicines without talking to your health care provider. Especially tell your health care provider if you take oxcarbazepine, carbamazepine, phenobarbital, phenytoin, primidone, clobazam, omeprazole, simvastatin, rosuvastatin, or birth control medicine.

Discontinuation: Do not stop taking APTIOM without first talking to your health care provider. Stopping APTIOM suddenly can cause serious problems.

Pregnancy and lactation: APTIOM may cause your birth control medicine to be less effective. Talk to your health care provider about the best birth control method to use. APTIOM may harm your unborn baby. APTIOM passes into breast milk. Tell your health care provider if you are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. You and your health care provider will decide if you should take APTIOM. If you become pregnant while taking APTIOM, talk to your health care provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy. You can enroll in this registry by calling 1-888-233-2334.

Get medical help right away if you have any of the symptoms listed above.

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.

For more information, please see the APTIOM Medication Guide and Full Prescribing Information.

About Sunovion Pharmaceuticals Inc. (Sunovion)

Sunovion is a global biopharmaceutical company focused on the innovative application of science and medicine to help people with serious medical conditions. Sunovion's vision is to lead the way to a healthier world. The company's spirit of innovation is driven by the conviction that scientific excellence paired with meaningful advocacy and relevant education can improve lives. With patients at the center of everything it does, Sunovion has charted new paths to life-transforming treatments that reflect ongoing investments in research and development and an unwavering commitment to support people with psychiatric, neurological, and respiratory conditions. Sunovion's track record of discovery, development and commercialization of important therapies has included Brovana® (arformoterol tartrate), Latuda® (lurasidone HCI), and most recently Aptiom® (eslicarbazepine acetate).

Headquartered in Marlborough, Mass. Sunovion is an indirect, wholly owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. Sunovion Pharmaceuticals Europe Ltd., based in London, England, Sunovion Pharmaceuticals Canada Inc., based in Mississauga, Ontario, and Sunovion CNS Development Canada ULC, based in Toronto, Ontario, are wholly-owned direct subsidiaries of Sunovion Pharmaceuticals Inc. Additional information can be found on the company's web sites: www.sunovion.com, www.sunovion.eu and www.sunovion.ca. Connect with Sunovion on Twitter, LinkedIn, Facebook and YouTube.

BROVANA is a registered trademark of Sunovion Pharmaceuticals Inc.

LATUDA is a registered trademark of Sumitomo Dainippon Pharma Co., Ltd.

APTIOM is under license from BIAL.

© 2016 Sunovion Pharmaceuticals Inc.

For a copy of this release, visit Sunovion's web site at www.sunovion.com

References

i Institute of Medicine (IOM). 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 July 2015. <http://www.ninds.nih.gov/disorders/epilepsy/epilepsy.htm>

iii Epilepsy Foundation. "Complex Partial Seizures." Accessed July 2015. <http://www.epilepsy.com/learn/types-seizures/complex-partial-seizures>.

iv Brodie MJ, Barry SJE, Bamagous GA, Norrie JD, Kwan P. Patterns of treatment response in newly diagnosed epilepsy. Neurology. 2012;78:1548-1554.

v Kwan P, Brodie MJ. "Early Identification of Refractory Epilepsy." New England Journal of Medicine (2000): 342(5):314-9. http://www.ncbi.nlm.nih.gov/pubmed/10660394.

vi Epilepsy Foundation. "If First Medicine Doesn't Work" http://www.epilepsy.com/learn/treating-seizures-and-epilepsy/treatment-101-basics/if-first-medicine-doesn't work. Accessed November 2016.

Sunovion Pharmaceuticals Inc.
Kristina Coppola, 508-787-4368
Senior Manager, Corporate Communications
kristina.coppola@sunovion.com

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