FDA Approves Eslicarbazepine as Add-On Therapy in Epilepsy

Susan Jeffrey

November 08, 2013

The US Food and Drug Administration (FDA) has approved eslicarbazepine acetate (Aptiom, Sunovion Pharmaceuticals) as adjunctive therapy for partial-onset seizures associated with epilepsy in adults, the agency announced today.

Partial seizures are the most common type of seizure in people with epilepsy, the statement notes.

"Some patients with epilepsy do not achieve satisfactory seizure control from existing treatments," said Eric Bastings, MD, acting director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research in the release. "It is important we continue to make new treatment options available to patients."

Randomized clinical studies in patients with partial epilepsy showed the drug is effective in reducing the frequency of seizures vs placebo, the statement said. The approval was based on 3 large phase 3 trials (Bia 2093-301, BIA 2093-302, and BIA 2093-304) including more than 1400 patients. The trials, jointly carried out with BIAL-Portela, the company that did the initial research and development of the drug, showed statistically significant reductions in standardized seizure frequency vs placebo. Significantly more treated patients had a seizure frequency reduction of 50% or more from baseline (41% vs 22%).

The most common adverse effects reported by those treated with the drug during the trials included dizziness, drowsiness, nausea, headache, double-vision, vomiting, fatigue, and loss of coordination, the FDA statement notes. "These and other side effects and recommendations for monitoring are described in the drug label."

Like other antiepileptic drugs, eslicarbazepine may cause suicidal thoughts or actions, and patients should contact their healthcare professional immediately if they have "thoughts about suicide or dying, new or worsened anxiety or depression, or other unusual changes in behavior or mood."

The drug is approved with a medication guide providing patients with information to help avoid serious adverse events, and will be distributed with each prescription refill.

A release from Sunovion notes that the FDA determined that eslicarbazepine will not be classified as a controlled substance. "Sunovion expects Aptiom to be available in US pharmacies in the second quarter (April - June) of 2014," the company said.

Sunovion has also been investigating the use of eslicarbazepine as monotherapy. Topline results of 2 phase 3 monotherapy trials of eslicarbazepine were just reported by the company and reported by Medscape Medical News at that time. In both trials the drug met the primary endpoints.

In February 2009, Eisai Europe Limited, a European subsidiary of Eisai Co., Ltd., entered into a license and copromotion agreement with BIAL, which gave the rights to Eisai to sell eslicarbazepine acetate under the trade name Zebinix in Europe, the Sunovion release notes. 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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