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FDA Approves New Indication for Seizure Therapy Eslicarbazepine (Aptiom)

Drug approved as monotherapy for partial-onset seizures

The FDA has given the nod to a supplemental new drug application for eslicarbazepine acetate (Aptiom, Sunovion Pharmaceuticals) as monotherapy for the treatment of partial-onset seizures. The new indication allows eslicarbazepine to be used as monotherapy in people who initiate treatment for the first time or convert from other antiepileptic drugs (AEDs) to eslicarbazepine.

Approved in 2013 as adjunctive therapy for partial-onset seizures, eslicarbazepine is the only once-daily non–extended-release AED that can be used alone or in combination with other AEDs in the treatment of partial-onset seizures.

The approval of eslicarbazepine as monotherapy for partial-onset seizures was supported by data from two identically designed phase III, dose-blinded, historical-controlled, randomized clinical trials. Both studies evaluated the safety and efficacy of eslicarbazepine (1,600 mg/day or 1,200 mg/day) as monotherapy for partial-onset seizures in patients 16 years of age or older whose seizures were not well-controlled with other AEDs.

The primary endpoint for both trials was the percentage of patients who withdrew from the studies because of predefined criteria identifying worsening seizure control compared with historical controls from previous, similarly designed trials of epilepsy patients converting to AED monotherapy. The results showed that conversion to eslicarbazepine monotherapy was associated with exit rates superior to those of historical controls in patients with partial-onset seizures who were not well-controlled by one or two current AEDs.

Eslicarbazepine administered once daily was generally well-tolerated in both dose strengths. The most common treatment-related adverse events in the two clinical trials included headache, dizziness, fatigue, somnolence, and nausea.

Eslicarbazepine is the latest member of the dibenzazepine carboxamide family of AEDs. The precise mechanism by which eslicarbazepine exerts its anticonvulsant activity is unknown, but it is thought to involve inhibition of voltage-gated sodium channels. Eslicarbazepine is not classified as a controlled substance by the FDA.

Epilepsy is the fourth most common neurological condition, and one in 26 people in the U.S. will develop the disorder in their lifetimes. Epilepsy manifests as unprovoked seizures, which are caused by abnormal firing of impulses from nerve cells in the brain. Partial-onset seizures, one type of seizure and the most common, 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.

Reducing the frequency of seizures can greatly lessen the burden of epilepsy. With approximately one-third of people with epilepsy still unable to control their seizures, there continues to be a need for new therapies. Up to 40% of people living with epilepsy do not respond to the first or second monotherapy, and approximately 36% do not have adequate control of their seizures despite the use of two or more antiepileptic medications.

Source: Sunovion Pharmaceuticals; August 28, 2015.


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