Aptiom Aims for Pediatric Indication for Partial Onset Seizures
If accepted, the supplemental NDA will allow physicians to prescribe Aptiom to patients aged ≥4 years.
Sunovion announced the submission of a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) for the use of Aptiom (eslicarbazepine acetate) as monotherapy or adjunctive therapy for the treatment of partial-onset seizures (POS) in children aged ≥4 years.
Aptiom, a dibenzazepine carboxamide antiepileptic, is currently approved for use as monotherapy or adjunctive therapy for POS in adults. It is thought to exert anticonvulsant activity through inhibition of voltage-gated sodium channels.
The company is seeking expansion of the indication based on the FDA guidance regarding the use of extrapolated data to support an application. The safety and efficacy of Aptiom as monotherapy and adjunctive therapy for the treatment of POS in adults was demonstrated in 5 multicenter, randomized, controlled clinical trials. All of the studies met the pre-specified primary endpoints as agreed on by the FDA.
The sNDA submission includes data from 3 clinical trials conducted by BIAL, supporting the safety and tolerability of of Aptiom for the treatment of POS in pediatric patients. In addition, it includes pharmacokinetic analyses from adult and pediatric data, supporting the proposed dosing regimen in pediatric patients.
Aptiom is available as 200mg, 400mg, 600mg, and 800mg strength tablets.