Sunovion Pharmaceuticals Inc. Announces FDA Approval of Aptiom ® (eslicarbazepine acetate) as Once - Daily Adjunctive Treatment of Partial - Onset Seizures

November 8, 2013

Marlborough, MA- Sunovion Pharmaceuticals Inc.(Sunovion) today announced that the U.S. Food and Drug Administration (FDA) approved Aptiom® (eslicarbazepine acetate),an antiepileptic drug (AED),for use as adjunctive treatment of 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 (U.S.) Partial-onset seizures are the most prevalent seizure type, accounting for 60%of new epilepsy diagnoses.

“Patients with partial-onset epilepsy often require adjunctive treatment to achieve better seizure control,” said Dr. Joseph Sirven, M.D., Chair of Neurology at Mayo Clinic in Arizona and Chair of the Epilepsy Foundation's Professional Advisory Board. “APTIOM is an important new treatment option with a well-established safety profile for healthcare providers and people living with epilepsy.”

The FDA has determined that APTIOM will not be classified as a controlled substance. Sunovion expects APTIOM to be available in U.S. pharmacies in the second quarter (April–June) of 2014.

The approval of APTIOM is based on three large Phase 3 randomized, double-blind, placebo-controlled, safety and efficacy trials (Studies BIA 2093-301, BIA-2093-302 and BIA-2093-304), which included more than 1,400 people living with partial-onset seizures inadequately controlled by one to three concomitant AEDs (including carbamazepine, lamotrigine, valproic acid and levetiracetam). In these global studies, which were jointly performed with BIAL-Portela & C S.A. (BIAL),treatment with APTIOM demonstrated statistically significant reductions in standardized seizure frequency versus placebo, and significantly more APTIOM treated patients experienced seizure frequency reduction of 50% or more from baseline (41% compared to 22% for placebo-treated patients).

The most common side effects in patients taking APTIOM include dizziness, somnolence, nausea, headache, diplopia, vomiting, fatigue, vertigo, ataxia, blurred vision and tremor. The rate of discontinuation as a result of any adverse event was 14% for the 800 mg dose, 25% for the 1,200 mg dose and 7% in subjects randomized to placebo.

"APTIOM will offer people with partial-onset seizures sustained seizure reduction in a once-daily, immediate-release formulation," said Antony Loebel, M.D., Executive Vice President and Chief Medical Officer at Sunovion. "The approval today significantly expands the treatment options Sunovion offers to patients with complex neurological disorders, and it marks the second FDA approval action this year for the Company’s central nervous system products."

 

About Partial-Onset Seizures

Epilepsy is characterized by abnormal firing of impulses from nerve cells in the brain. 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. 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. Reducing the frequency of seizures can greatly lessen the burden of epilepsy. With approximately 30%of people living with epilepsy still unable to control seizures, there continues to be a need for new therapies.

 

About APTIOM

APTIOM, a voltage-gated sodium channel inhibitor, is a prescription medicine approved for use as adjunctive treatment of partial-onset seizures. Treatment with APTIOM should be initiated at 400 mg once daily. After one week, dosage may be increased to the recommended maintenance dosage of 800 mg once daily. Some patients may benefit from the maximum recommended maintenance dosage of 1,200 mg once daily, although this dosage is associated with an increase in adverse reactions. The maximum dose of 1,200 mg daily should onlybe initiated after the patient has tolerated 800 mg daily for at least a week. For some patients, treatment may be initiated at 800 mg once daily if the need for additional seizure reduction outweighs an increased risk of adverse reactions during initiation.

The initial research and development of eslicarbazepine acetate was performed by BIAL, a privately held Portuguese research-based pharmaceutical company. Subsequently, Sunovion acquired the rightsunder an exclusive license to further develop and commercialize eslicarbazepine acetatein the U.S. andCanadian markets from BIAL. In February 2009, Eisai Europe Limited, a European subsidiary of Eisai Co., Ltd. (Eisai),entered into a license and co-promotion agreement with BIAL, which gave the rights to Eisai to sell eslicarbazepine acetate under the trade name Zebinix® in Europe. 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.

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