U.S. FDA approves Sunovion Pharmaceuticals' seizure drug

Fri Nov 8, 2013 4:35pm EST

Nov 8 (Reuters) - U.S. health regulators on Friday approved a new drug made by Sunovion Pharmaceuticals, a U.S.-based unit of Japanese drugmaker Dainippon Sumitomo Pharma Co, as an add-on medicine to reduce seizures associated with epilepsy.

The drug, to be sold under the brand name Aptiom and known chemically as eslicarbazepine, significantly reduced the frequency of epileptic seizures compared with a placebo in clinical trials.

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

Like other antiepileptic drugs, Aptiom may cause suicidal thoughts or actions in a very small number of people, the Food and Drug Administration cautioned in its approval announcement.

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