~ Trileptal® in tablets and suspension represent the first new product in the treatment of epilepsy in five years ~
Dorval, Quebec (June 11, 2002) -- Novartis Pharmaceuticals Canada and Oryx Pharmaceuticals Inc. announced today that Trileptal® (oxcarbazepine) in tablets and suspension is now available for sale in Canada. Trileptal® is the only second generation antiepileptic drug (AED) indicated for the treatment of partial seizures in adults at three key stages of therapy: at the initiation of monotherapy, for the conversion from existing AED's to monotherapy in adults, and as adjunctive therapy in adults and children (six years of age and over). Novartis and Oryx have entered into an agreement whereby Oryx will be responsible for the marketing and promotion of Trileptal® in Canada.
"Canadian neurologists will welcome the addition of Trileptal® as a necessary new treatment option to control the debilitating symptoms of epilepsy and improve the quality of life for people with seizures," says Dr. Frederick Andermann, Professor of Neurology at McGill University and epileptologist at the Montreal Neurological Hospital and Institute.
Epilepsy is a physical condition characterized by sudden, brief changes in how the brain works. It is a symptom of a neurological disorder - a disorder that affects the brain and shows itself in the form of seizures. Partial or local seizures, which begin in a localized area of the brain, account for approximately 50-70 per cent of seizure disorders, making them the most common kind of seizure.
"To control their seizures, many patients require treatment with more than one AED, which can cause side effects," said Dr. Beat Sümegi, Vice President, Medical Affairs, Novartis Pharmaceuticals Canada. "Treatment with a new potent medication like Trileptal® can help patients achieve excellent control with good tolerability."
About 300,000 Canadians (approximately 1 per cent of the country's population) have epilepsy. They include people who require anticonvulsant drugs for seizure control. The cause of epilepsy in 75 per cent of children and 50 per cent of adults with the condition is unknown. In the remainder, the following causes are most often identified: brain tumour or stroke, head trauma, injury, infection or systemic illness of the mother, brain injury to infant during delivery and aftermath of infection.
Proven Efficacy
Ten controlled clinical trials have established that Trileptal® is safe and efficacious in the treatment of partial seizures across a wide range of ages (children to adults), patient types (recent onset to treatment-resistant epilepsy), and place in therapy (monotherapy and adjunctive therapy).
Established Safety and Tolerability
Trileptal® has demonstrated a good safety and tolerability profile with generally fewer drug-drug interactions than other first-line monotherapy AED's. Furthermore, Trileptal® has been marketed in more than 50 countries since 1990, and post-launch patient surveillance data has reinforced the safety and tolerability of this important AED.
Canadian Experience
In addition to the Canadian clinical trial experience, hundreds of Canadian patients enrolled in a Novartis Special Access Program have already benefited from the significant advantages associated with Trileptal®. In many of these situations, patients were enrolled in this Trileptal® access program because other medications had failed.
Social Impact
Although many famous people including Julius Caesar, Ludwig Van Beethoven, Charles Dickens and Richard Burton have suffered from epilepsy in their lives, there remains a strong stigma surrounding the condition and a prejudice with which society continues to treat people with the condition. This has resulted in many patients who are reluctant to admit they have the condition or to seek treatment. As a result, the prevalence of epilepsy may be higher than reported in current data. There are more than twice as many people with epilepsy in Canada as the number of people with cerebral palsy (55,000), muscular distrophy (28,000), multiple sclerosis (39,000), and cystic fibrosis (3,400) combined.
About Novartis Canada
Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field, is committed to the discovery, development and marketing of innovative products to improve the well being of all Canadians. Novartis Pharmaceuticals Canada conducts hundreds of clinical trials across the country seeking new treatments for cardiovascular disease, diabetes, cancer, organ transplantation and glaucoma. In 2001, the Company invested $34 million in research and development. Novartis Pharmaceuticals Canada Inc. employs approximately 650 people in Canada and its headquarters are located in Dorval, Quebec. In addition to Novartis Pharmaceuticals Canada Inc., the Novartis Group in Canada consists of Novartis Animal Health Canada Inc., Novartis Consumer Health Canada Inc., (including Novartis Nutrition Corporation and Gerber [Canada] Inc.) and CIBA Vision Canada Inc.
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