Business Editors/Health/Medical Writers
EAST HANOVER, N.J.--(BUSINESS WIRE)--Dec. 10, 2002
The antiepileptic drug (AED) Trileptal (R) (oxcarbazepine, Novartis Pharmaceuticals Corporation) maintains efficacy during long-term treatment in patients with partial seizures, according to data from the two-year open-label extension phases of three studies. The results were presented at the 56th annual meeting of the American Epilepsy Society.
"The ability of an anti-epilepsy medication to gain and maintain control of seizures over an extended period of time is an important characteristic," said Tracy Glauser, M.D., director of the Comprehensive Epilepsy Center at the Children's Hospital Medical Center in Cincinnati and author of one of the studies. "These data show Trileptal helped reduce seizure frequency over the long term in various epilepsy patient populations."
The first study, presented on December 9th by Dr. Glauser, was an open-label extension phase of a trial that examined the safety and efficacy of Trileptal as adjunctive therapy in children (aged 3-17) who experienced seizures while taking other AEDs. Two hundred thirty-three children who had been enrolled in a double-blind, placebo-controlled, parallel-group trial entered the study's open-label extension phase. During the two-year extension, 55% of patients experienced a 50% or greater reduction in seizure frequency, 31% of patients experienced a 75% or greater reduction in seizure frequency, and 6% of patients experienced a 100% reduction in seizure frequency. In all, 128 patients completed the two-year open-label extension. The most common adverse events seen in the study were headache (37%), vomiting (36%), somnolence (33%), dizziness (32%), viral infection (27%), fever (24%) and upper respiratory infection (23%).
The second study was presented on December 10th by Daniela Minecan, M.D., clinical assistant professor in the Department of Neurology at the University of Michigan Medical School. Dr. Minecan reported on the two-year open-label extension phase of a study that examined the safety and efficacy of Trileptal as monotherapy in patients (aged 11-66) with partial seizures. In all, 35 of 76 patients completed the additional two years of therapy. Other AEDs were allowed. The maximum allowable dose of Trileptal was 3000 mg/day unless otherwise approved. Overall, 47% of patients experienced a 50% or greater reduction in seizure frequency, 24% experienced a 75% or greater reduction, and 7% experienced a 100% reduction of seizures during this two-year period. Of those on Trileptal as monotherapy, 59% experienced a 50% or greater reduction in seizure frequency, 36% experienced a 75% or greater reduction, and 10% experienced a 100% reduction. Of those receiving Trileptal as adjunctive therapy, 35% experienced a 50% or greater reduction in seizure frequency, 11% experienced a 75% or greater reduction, and 3% experienced a 100% reduction. The most common adverse events were dizziness (46%), headache (32%), fatigue (30%), diplopia (30%), nausea (26%), abnormal vision (21%) and somnolence (21%).
The third study, presented on December 10th by Steven Schachter, M.D., associate professor of neurology at Harvard Medical School, evaluated the two-year open-label extension phase of a trial of Trileptal as monotherapy in partial seizure patients (aged 11-62) who were candidates for surgical treatment of epilepsy. Of the 97 patients who entered the open-label extension phase, 43 completed two years of treatment. The maximum allowable dose was 3000 mg/day unless otherwise approved. During the 10-day double blind treatment phase, 13 of 51 patients treated with Trileptal experienced a 100% reduction in seizures. Five of these patients continued to experience a 100% reduction in seizures during the two-year open-label extension phase. Throughout the two-year period, the most common adverse events were headache (61%), dizziness (58%), diplopia (45%), fatigue (41%), nausea (36%), vomiting (27%), somnolence (24%), viral infection (22%) and abnormal vision (21%).
About Trileptal (R)
Trileptal is indicated for use as monotherapy or adjunctive therapy in the treatment of partial seizures in adults and as adjunctive therapy in the treatment of partial seizures in children as young as four years of age. Trileptal has been extensively studied and has demonstrated efficacy in both newly diagnosed adult patients as well as patients who experience seizures while taking other AEDs.
Trileptal has a favorable safety profile. There is no black box warning and it is not associated with aplastic anemia, agranulocytosis, hepatotoxicity or pancreatitis. In addition, no monitoring of drug level, liver functions or blood counts is required. As monotherapy in adults, Trileptal is well tolerated, with discontinuation rates comparable to placebo.
Trileptal is not generally associated with weight gain or cosmetic side effects. As monotherapy or adjunctive therapy in adults previously treated with AEDs, the most common (greater than 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. As add-on therapy in pediatric patients, adverse events with Trileptal were similar to adults.
Clinically significant hyponatremia (sodium less than 125 mmol/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 of 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 Trileptal. Caution should be exercised when prescribing Trileptal for patients with a history of hypersensitivity to carbamazepine. (Please see Warnings section of complete prescribing information.)
The foregoing press release contains forward-looking statements that can be identified by forward-looking terminology, such as "support" and "maintains efficacy," or similar expressions. Such forward looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results to be materially different from any future results, performance, or achievements expressed or implied by such statements. In particular, management's expectation regarding the commercial success of Trileptal could be affected by amongst other things, uncertainties relating to product development, regulatory actions or delays or government regulation generally, the ability to obtain or maintain patent or other proprietary intellectual property protection and competition in general, as well as factors discussed in the Company's Form 20F filed with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein anticipated, believed, estimated or expected.
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.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG. Novartis AG (NYSE: NVS) is a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal health. In 2001, the Novartis Group's ongoing businesses achieved collective sales of CHF 32.0 billion (USD 19.1 billion) and a net income of CHF 7.0 billion (USD 4.2 billion). The Group invested approximately CHF 4.2 billion (USD 2.5 billion) in R&D. Novartis AG is headquartered in Basel, Switzerland. Novartis Group companies employ about 74,000 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.
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