Oxcarbazepine in Canada
In June, Novartis Pharmaceuticals Canada and Oryx Pharmaceuticals Inc. announced that oxcarbazepine (Trileptal®) in tablets and suspension is now available for sale in Canada. This represents the first new product in the treatment of epilepsy in 5 years.
Trileptal® is the only second generation antiepileptic drug (AED) indicated for the treatment of partial seizures in adults at 3 key stages of therapy: at the initiation of monotherapy, for the conversion from existing AEDs to monotherapy in adults, and as adjunctive therapy in adults and children (6 years of age and older). Novartis and Oryx have entered into an agreement whereby Oryx will be responsible for the marketing and promotion of Trileptal® in Canada.
Controlled clinical trials have established that oxcarbazepine 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). Oxcarbazepine has demonstrated a good safety and tolerability profile with generally fewer drug-drug interactions than other first-line monotherapy AEDs.
Oxcarbazepine has been marketed in more than 50 countries since 1990, and post-launch patient surveillance data have reinforced its safety and tolerability record. In addition to the Canadian clinical trial experience, hundreds of Canadian patients were enrolled in a Novartis Special Access Program, many because other medications had failed.
Sources
Media Release from Novartis Pharmaceuticals Canada, 11 June 2002
http://www.novartis.ca
http://www.novartis.com
http://www.oryxpharma.com
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