Trileptal

The Food and Drug Administration has granted marketing clearance for Novartis Pharmaceuticals' Trileptal (oxcarbazepine) tablets. Trileptal is an antiepileptic drug (AED) indicated for the treatment of partial seizures as monotherapy in adults or adjunctive therapy in adults and children four years and older. The company said Trileptal has demonstrated a good safety profile and tolerability in 34 trials involving more than 2,600 subjects, with fewer drug-drug interactions than other first-line monotherapy AEDs. In total, the FDA-reviewed safety database included more than 6,900 patients.

In controlled monotherapy trials of newly diagnosed patients, 57 percent to 61 percent of those on Trileptal were seizure-free during 48 weeks of study, and in a 10-day trial of epilepsy surgery candidates who were previously unresponsive to other AEDs, 25 percent of patients given Trileptal remained seizure-free compared to 2 percent of placebo patients. Use of Trileptal as adjunctive therapy was also evaluated in two multicenter, randomized trials; Trileptal use resulted in fewer seizures when added to a prior drug regimen of one or more other AEDs.

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