Sunovion Submits NDA to Expand Aptiom Indication to Pediatric Patients

Tuesday, March 14, 2017 | Epilepsy & Seizure Disorders


Sunovion Pharmaceuticals has submitted a supplemental new drug application (sNDA) to the 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. The submission is based on data from three clinical trials 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, according to Sunovion.

An 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 company is also planning a Phase 3 clinical study in children younger than four years of age.

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