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.