EAST HANOVER, N.J., Nov. 28 /PRNewswire/ -- Novartis Pharmaceuticals Corporation announced today that the U.S. Food and Drug Administration (FDA) has approved Trileptal(R) (oxcarbazepine) tablets and oral suspension as adjunctive therapy (use in combination with other antiepileptic drugs) in the treatment of partial seizures in children as young as two-years old with epilepsy.
“The approval of Trileptal as adjunctive therapy in children as young as two represents an advance in the treatment of pediatric epilepsy,” said Tracy Glauser, MD, professor of pediatrics and neurology, director of the Comprehensive Epilepsy Program, Cincinnati Children’s Hospital Medical Center and Trileptal clinical trial investigator. “Trileptal has a proven track record of effective seizure control with favorable safety and tolerability and now those benefits can be extended to children as young as two years of age.”
The new Trileptal indication is based on data from a multicenter, rater-blind, randomized study. The study evaluated 128 pediatric patients who were still experiencing partial seizures while taking up to two concomitant AEDs. Patients received either high-dose (60 mg/kg/day) or low-dose (10 mg/kg/day) Trileptal oral suspension. High-dose Trileptal adjunctive therapy was significantly more effective in controlling partial seizures in young children than treatment with low-dose Trileptal, and both doses were generally well tolerated. Study results will be published in an upcoming issue of the medical journal Neurology.
“Treating epilepsy in children has different issues from treating adults -- the differences primarily relate to the growth and development process, which can affect or be affected by epilepsy treatment,” said Angus Wilfong, MD, professor of neurology and pediatrics, Baylor College of Medicine, Texas Children’s Hospital. “The selection of AEDs for children with epilepsy should therefore be based on clinical studies specifically designed to evaluate efficacy, safety, tolerability and pharmacokinetics in young patients.”
Approximately 300,000 children aged 14 and younger have epilepsy and approximately 25% of children with epilepsy do not have adequate seizure control.
Trileptal is already indicated for use as monotherapy or adjunctive therapy in the treatment of partial seizures in adults and children four years of age and older with epilepsy. Trileptal was the first AED in 25 years to be approved for use as monotherapy in children and has been available in the United States since February 2000.
Safety and Tolerability
The addition of Trileptal to existing AED therapy was generally well tolerated among young pediatric patients. Most adverse events (AEs) were rated as mild in severity and few patients (3.9%) discontinued prematurely due to AEs. The frequency of AEs suspected to be related to Trileptal was higher in the high-dose group compared with the low-dose group, and the most frequent of these AEs were somnolence, ataxia, and vomiting. The most commonly observed (greater than or equal to 5%) adverse experience seen in association with Trileptal in these patients were similar to those seen in older children and adults except for infections and infestations which were more frequently seen in these younger children.
Important Safety Information
As monotherapy or adjunctive therapy in adults previously treated with AEDs, the most common (greater than or equal 5%) 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. Adverse events with Trileptal experienced by children were similar to those of adults, except for infections and infestations which were more frequently seen in children < 4 years.
Clinically significant hyponatremia (sodium < 125mEq/L) has been observed in 2.5% of Trileptal-treated patients in controlled clinical trials. Measurement of serum sodium levels should be considered for patients at risk for hyponatremia (Please see WARNINGS section of complete prescribing information.)
Of patients who have had hypersensitivity to carbamazepine, 25% to 30% will experience a reaction to oxcarbazepine. Caution should be exercised when prescribing Trileptal for patients with a history of hypersensitivity to carbamazepine. (Please see WARNINGS section of complete prescribing information.)
Serious dermatological reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with Trileptal use. Should a patient develop a skin reaction while using Trileptal, consideration should be given to discontinuing its use. (Please see WARNINGS section of complete prescribing information.)
About Novartis
Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including central nervous system disorders, organ transplantation, cardiovascular diseases, dermatological diseases, respiratory disorders, cancer and arthritis. The company’s mission is to improve people’s lives by pioneering novel healthcare solutions.
Novartis has been a leader in the neuroscience area for more than 50 years, having pioneered early breakthrough treatments for Alzheimer’s disease, Parkinson’s disease, Attention Deficit Hyperactivity Disorder, epilepsy, schizophrenia and migraine, many of which continue to be regarded as “gold standards” to this day. Novartis Neuroscience continues to be at the forefront of research and development of new compounds, is committed to addressing unmet medical needs and to supporting patients and families affected by these disorders.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG. Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2004, the Group’s businesses achieved sales of USD 28.2 billion and a net income of USD 5.8 billion. The Group invested approximately USD 4.2 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 81,400 people and operate in over 140 countries around the world. For further information, please consult http://www.novartis.com.
Contacts: Laurie Ostroff-Landau Novartis Pharmaceuticals Corporation +1 862 778 0319 (direct) +1 973 493 7971 (mobile) laurie.ostrofflandau@novartis.com
Gina Moran Novartis Pharmaceuticals Corporation +1 862 778 5567 (direct) +1 973 476 3643 (mobile) gina.moran@novartis.com
Emily Baier Feinstein Kean Healthcare +1 617 761 6708 (direct) +1 617-921-4980 (mobile) emily.baier@fkhealth.com
SOURCE Novartis Pharmaceuticals Corporation
Web site: http://www.novartis.com/
