Aptiom as once-daily adjunctive treatment of partial-onset seizures, FDA approved


Sunovion Pharmaceuticals has announced that the FDA ( Food and Drug Administration ) has 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 ( CDC ), affects nearly 2.2 million people in the United States. Partial-onset seizures are the most prevalent seizure type, accounting for 60% of new epilepsy diagnoses.

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 antiepileptic drugs ( including Carbamazepine, Lamotrigine, Valproic acid and Levetiracetam ). In these global studies, 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.

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.

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 only be 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. ( Xagena )

Souce: Sunovion Pharmaceuticals, 2013

XagenaMedicine_2013



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