Sunovion's eslicarbazepine successful in Ph III epilepsy studies

Sunovion Pharmaceuticals, a US subsidiary of Japan’s Dainippon Sumitomo Pharma (TYO: 4506), says that two completed Phase III trials of eslicarbazepine acetate (ESL) as a monotherapy treatment (Studies 093-045 and 093-046) met their primary endpoint.

ESL was well-tolerated and demonstrated seizure control rates superior to historical controls in adult patients with partial-onset seizures with or without secondary generalization who were not well-controlled by current antiepileptic drugs (AEDs). ESL is an investigational AED currently under review by the US Food and Drug Administration for use as a once-daily adjunctive therapy in the treatment of partial-onset seizures in patients 18 years and older with epilepsy. The efficacy and safety of ESL as an adjunctive or monotherapy treatment for partial-onset seizures in adults living with epilepsy has not yet been established.

Detailed results from Studies 093-045 and 093-046 will be presented at upcoming scientific meetings. The drug, originated by Portugal’s largest drugmaker Bial, is also being developed by Japan’s Eisai under the trade name Exalief.