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| |  Anticonvulsant, Trileptal, Approved By FDA For Patients As Young As Four EAST HANOVER, NJ -- January 17, 2000 -- Novartis Pharmaceuticals Corporation announced that the U.S. Food and Drug Administration (FDA) has granted marketing clearance for Trileptal(R) (oxcarbazepine) tablets. Trileptal belongs to the class of drugs known as anticonvulsant or antiepileptic drugs (AEDs). The medication is indicated for the treatment of partial seizures as monotherapy in adults or adjunctive therapy (use in combination with other AEDs) in adults and children as young as four years of age.
The company also expects marketing introductions in all European Union (EU) member states later this year, following the successful completion of the European Mutual Recognition Procedure (MRP) on November 30, 1999. "Currently, approximately 30-50 percent of people with epilepsy may continue to experience seizures despite treatment with the medications now available, and for those who are able to control their seizures the price is often troubling side effects," said Rajesh Sachdeo, MD, Clinical Professor of Neurology at the University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School and Director, New Jersey Comprehensive Epilepsy Center. "In clinical trials we've seen excellent seizure free rates with Trileptal and the medication is very well tolerated." 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. Treatment with one medication is the goal as it usually means fewer side effects and improved compliance; however, some patients are not able to achieve control with one medication. Therefore, a drug that can be used either alone or with other AEDs provides optimal flexibility for meeting different patient needs. In evaluating Trileptal for marketing clearance, the FDA reviewed results from 34 trials involving more than 2,600 subjects. In total, the safety database reviewed by the FDA included more than 6,900 patients. Four well-controlled multicenter trials were conducted in the U.S. to demonstrate the safety and efficacy of Trileptal as monotherapy. In these trials, Trileptal demonstrated efficacy (compared to placebo or low doses of Trileptal) in those patients poorly controlled on their current therapies and in newly diagnosed patients. 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. In other controlled monotherapy trials of newly diagnosed patients, 57-61 percent of those on Trileptal were seizure free during 48 weeks of study. 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 or more other AEDs: - In adult patients, Trileptal significantly reduced the frequency of seizures as compared to placebo. 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 (healthcare and related) and indirect (income) costs. "The introduction of Trileptal in the United States provides long awaited new hope for people with seizure disorders and their families," said Steven Schachter, MD, Chair of the Epilepsy Foundation Professional Advisory Board. "It can be started at an effective dose thereby increasing the likelihood of attaining control quickly. Moreover, it has few dose-limiting side effects, meaning that physicians can raise the dose as necessary to control seizures in patients who require higher doses of medication." Trileptal has demonstrated a good safety profile and tolerability with fewer drug-drug interactions than other first-line monotherapy AEDs. 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. In clinical trials, there was no significant difference between Trileptal and placebo in side effects that especially concern people with epilepsy, such as, coarsening of the facial features; gingival hyperplasia (swelling of the gums); hirsutism (abnormal hair growth); difficulty concentrating; memory problems; abnormal coordination; weight gain; tremor; hair loss or rash. The side effects associated with Trileptal in monotherapy (greater than or equal to 5 percent) were dizziness, nausea, headache, diarrhea, vomiting, upper respiratory tract infection, constipation, dyspepsia, ataxia and nervousness. A less commonly seen side effect (2.5 percent in controlled clinical trials) was hyponatremia (low serum sodium levels), which was usually asymptomatic and did not usually require dose adjustments. Trileptal should not be used in patients with a known hypersensitivity to oxcarbazepine or to any of its components.
Related Link: Novartis Pharmaceuticals Corporation.
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