Phase 3 Trial Data for Oxtellar XR To Be Released

Supernus Pharmaceuticals, Inc. has announced the publication of Phase 3 pivotal trial data on Oxtellar XR (oxcarbazepine), which will appear in the March issue of Acta Neurologica Scandinavica.

The Prospective, Randomized Study of Oxcarbazepine extended release in Subjects with Partial Epilepsy Refractory (PROSPER) trial was a multinational, randomized, double-blind, parallel-group, placebo-controlled study that evaluated safety and efficacy of once-daily Oxtellar XR 1200 mg and 2400 mg doses when added to 1–3 concomitant antiepileptic drugs in adults with refractory partial-onset seizures, with or without secondary generalization. It consisted of an 8-week prospective observation phase for establishing baseline frequency of seizures, a double-blind 4-week treatment period titration phase, a 12-week maintenance phase, and a 3-week interval for blinded conversion to open-label treatment or tapering to baseline therapy.

The primary efficacy endpoint of median percent reduction from baseline in monthly (28-day) seizure frequency for the 16-week double-blind treatment period in the intent-to-treat (ITT) population with analyzable seizure data was met, with a significant median percent reduction compared to placebo at 2400 mg (P=0.003). Oxtellar XR was significantly superior to placebo in median percent seizure reduction (placebo: −13.3%; 1200mg: −34.5%, P=0.02; 2400 mg: −52.7%, P=0.006) in the North American study site cluster.

Oxtellar XR indicated for adjunctive therapy in the treatment of partial seizures in children 6–17 years of age and adults. It is the only approved once-daily extended-release formulation of oxcarbazepine for the treatment of epilepsy.

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