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Epilepsy Drug Oxtellar XR (Oxcarbazepine) Launched in U.S.

Once-daily tablets indicated for adults and for children aged 6 to 17 years (Feb. 1)

The antiepileptic drug Oxtellar XR (extended-release oxcarbazepine; Supernus Pharmaceuticals) is now available for sale in the U.S., according to a Feb. 1 announcement. The once-daily tablets are indicated for adjunctive therapy in the treatment of partial seizures in adults and in children 6 to 17 years of age. Product promotion begins on Feb. 4.

The recommended dosage of Oxtellar XR is 1,200 mg to 2,400 mg once daily for adults, and 900 mg to 1,800 mg once daily for children 6 to 17 years of age, depending on weight. The product is available in 150-mg, 300-mg, and 600-mg extended-release tablets.

The pharmacologic activity of Oxtellar XR is primarily exerted through the 10-monohydroxy (MHD) metabolite of oxcarbazepine. The precise mechanism by which oxcarbazepine and its MHD metabolite achieve their antiseizure effect is unknown; however, in vitro electrophysiologic studies indicate that they block voltage-sensitive sodium channels, resulting in stabilization of hyperexcited neural membranes, inhibition of repetitive neuronal firing, and diminution of the propagation of synaptic impulses. In addition, increased potassium conductance and modulation of high-voltage activated calcium channels may contribute to the drug’s anticonvulsant effects.

Sources: Supernus Pharmaceuticals; February 1, 2013; and Oxtellar XR PI; October 2012.

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