You are here

Oxtellar XR (Extended-Release Oxcarbazepine) Approved for Epilepsy

Drug indicated as adjunctive therapy for partial seizures (Oct. 22)

The FDA has approved the antiepileptic drug Oxtellar XR (Supernus Pharmaceuticals), an extended-release formulation of oxcarbazepine (formerly known as SPN-804), as adjunctive therapy in the treatment of partial seizures in adults and in children 6 to 17 years of age.

The recommended daily dose for adults is 1,200 mg to 2,400 mg. For children, the recommended daily dose is 900 mg to 1,800 mg, depending on weight. The product will be available in 150-mg, 300-mg, and 600-mg extended-release tablets.

The FDA granted the manufacturer a waiver for the pediatric study requirement for ages birth to 1 month and a deferral for submission of post-marketing assessments for children 1 month to 6 years of age. The post-marketing pharmacokinetic assessments are due in 2016, followed by clinical assessments in 2021.

Oxcarbazepine works by decreasing abnormal electrical activity in the brain.

Source: Supernus Pharmaceuticals, October 22, 2012.

Recent Headlines

Declining lung cancer mortality helped fuel the progress
Kinase inhibitor targets tumors with a PDGFRA exon 18 mutation
Delayed surgery reduces benefits; premature surgery raises risks
Mortality nearly doubled when patients stopped using their drugs
Acasti reports disappointing results for a second Omega-3-based drug
Fast-acting insulin aspart may simplify mealtime dosing
Simple change in dosage and route may improve a century-old vaccine
Neurodevelopmental deficits detected in Colombian toddlers
Improvement in overall survival fails to reach statistical significance