Supernus announced that the Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Oxtellar XR (oxcarbazepine) to include monotherapy use for the treatment of partial-onset seizures patients aged ≥6 years.
Oxtellar XR, an antiepileptic, was previously approved as adjunctive therapy to treat partial seizures in adults and in children aged 6–17 years. The exact mechanism of action by which oxcarbazepine exerts its antiseizure effect is unknown but it is thought to involve blocking of voltage-sensitive sodium channels, resulting in stabilization of hyperexcited neural membranes, inhibition of repetitive neuronal firing, and diminution of propagation of synaptic impulses.
Oxtellar XR has been evaluated as adjunctive therapy for partial-onset seizures in adults; its use in pediatric patients was based on adequate and well-controlled studies in adults, along with clinical trials of immediate-release oxcarbazepine in pediatric patients, and on pharmacokinetic evaluations of the use of Oxtellar XR in pediatric patients.
The Company plans to launch Oxtellar XR in the first quarter of 2019 as a new monotherapy option for partial-onset seizures. It is available as 150mg, 300mg, and 600mg extended-release tablets in 100-count bottles.
For more information call (866) 398-0833 or visit Oxtellarxr.com.