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| |  FDA Approves Oral Suspension of Trileptal (Oxcarbazepine) For Epilepsy EAST HANOVER, NJ -- May 31, 2001 -- Novartis Pharmaceuticals Corporation announced today that the U.S. Food and Drug Administration (FDA) has granted marketing clearance for an oral suspension formulation of Trileptal® (oxcarbazepine), which has been available since February 2000 in tablet form. Novartis developed the liquid formulation of the drug for people with epilepsy who have difficulty taking tablets. "Many people, particularly children, the elderly, and patients who are mentally impaired have difficulty swallowing medication in tablet form," said Joseph D'Souza, Ph.D., Trileptal International Clinical Leader, Novartis Pharmaceuticals Corporation. "The Trileptal oral suspension provides the same effective seizure control as Trileptal tablets, but in an easy-to-swallow liquid formulation." Trileptal belongs to the class of drugs known as anticonvulsants or antiepileptic drugs (AEDs). The medication is indicated for use as monotherapy or adjunctive therapy (use in combination with other AEDs) in the treatment of partial seizures in adults with epilepsy and as adjunctive therapy in the treatment of partial seizures in children aged four to 16. Partial seizures, which are seizures that begin in a localized area of the brain, account for up to 70 percent of seizure disorders, making them the most common kind of seizure. The oral suspension has a lemon flavoring and can be mixed in a small glass of water just prior to administration or swallowed directly from the oral syringe provided with each bottle. The medication can be taken with or without food. The effectiveness of Trileptal as adjunctive and monotherapy for partial seizures in adults, and as adjunctive therapy in children aged four to 16, was established in six multicenter, randomized, double-blind, controlled trials. Four well-controlled multicenter trials demonstrated efficacy as monotherapy (compared to placebo or low doses of Trileptal) in those patients not achieving desired results on their first AED and in newly diagnosed patients. Use of Trileptal as adjunctive therapy was evaluated in two multicenter, randomized, double-blind, placebo-controlled trials. Trileptal use resulted in fewer seizures when added to a prior drug regimen of one to three AEDs. Seizure disorders affect approximately 2.3 million American children and adults, with approximately 181,000 new cases occurring annually, and have an annual U.S. price tag of approximately $12.5 billion in direct and indirect costs. Trileptal has demonstrated a good safety and tolerability profile with few drug-drug interactions. Drug-drug interactions are of significant concern for all people on prescription and over-the-counter medications and especially for elderly patients who are usually taking a number of different drugs for concomitant conditions. Adverse events that are common concerns of patients with epilepsy, such as, coarsening of the facial features, gingival hyperplasia (swelling of the gums), hirsutism (abnormal hair growth), weight gain, or hair loss were generally not seen with Trileptal. As monotherapy or adjunctive therapy in adults previously treated with other AEDs, the most common (greater than or equal to 5 percent) adverse events occurring substantially more frequently than in placebo patients were dizziness, somnolence, diplopia, fatigue, nausea, vomiting, ataxia, abnormal vision, abdominal pain, tremor, dyspepsia, and abnormal gait -- these were typically mild to moderate in severity. A less commonly seen adverse event (2.5 percent in controlled clinical trials) was hyponatremia (serum odium levels below 125 mmol/L). Measurement of serum sodium levels should be considered for patients at risk for hyponatremia. Trileptal should not be used in patients with a known hypersensitivity to oxcarbazepine or to any of its components. Of patients who have had hypersensitivity to carbamazepine, 25 to 30 percent will experience a reaction to oxcarbazepine.
SOURCE: Novartis Pharmaceuticals Corporation Related Link: Novartis Pharmaceuticals Corporation.
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