Sunovion Submits sNDA to FDA for Use of APTIOM® for the Treatment of Partial-Onset Seizures in Child

Sunovion Pharmaceuticals has submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) to expand the indication for its antiepileptic drug (AED) APTIOM® (eslicarbazepine acetate) to include use as monotherapy or adjunctive therapy for the treatment of partial-onset seizures (POS) in children four years of age and older.

APTIOM is the only exclusively once-daily, immediate release antiepileptic drug (AED) that is FDA-approved for use as monotherapy or adjunctive therapy for POS in adults. The treatment can be taken whole or crushed, with or without food, and can be administered with flexible dosing based on patient response and tolerability.

"Sunovion is committed to the continued development of APTIOM to bring this treatment option to as many people as possible who experience partial-onset seizures," said Antony Loebel, M.D., Executive Vice President and Chief Medical Officer at Sunovion, Head of Global Clinical Development for Sumitomo Dainippon Pharma Group. "There is a significant need for new therapeutic options for children and adolescents with partial-onset seizures. Approximately one-third of people living with epilepsy are unable to control their seizures through available treatments, including the approximately 60 percent of people with epilepsy who have partial-onset seizures."

Sunovion is seeking an expansion of APTIOM’s indication for adjunctive therapy and monotherapy in adults to include children four years of age and older based on FDA guidance regarding the use of extrapolation of data to support an application. The safety and efficacy of APTIOM as monotherapy and adjunctive therapy for the treatment of POS in adults was established in five multicenter, randomized, controlled clinical trials. All trials met the pre-specified primary endpoints agreed upon with the FDA. In the sNDA submission, Sunovion will also include data from three clinical trials conducted by our partner BIAL-Portela & C.a, S.A. (BIAL), which support the safety and tolerability of APTIOM for the treatment of POS in pediatric patients, along with pharmacokinetic analyses from adult and pediatric data, which support the proposed dosing regimen in the pediatric population.

Sunovion’s ongoing development program for APTIOM includes a Phase 4 study in adults with POS that is designed to evaluate APTIOM in real-world clinical settings supporting the use of APTIOM as adjunctive therapy for POS. The study includes an exploratory endpoint to evaluate the use of the Embrace watch by Empatica, an investigational wearable device with unique proprietary technology, to detect and record POS subjectively identified by patients or caregivers. This is the first time that a wearable seizure detection device has been incorporated into the trial design of an AED for POS such as APTIOM. Additionally, Sunovion is planning a Phase 3 clinical study in children younger than four years of age.