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| |  Lamictal Approved In Canada For Rare Childhood Epilepsy TORONTO, ON -- June 10, 1999 -- Health Canada has approved Glaxo Wellcome Inc.’s Lamictal(R) (lamotrigine), a new treatment for a rare and severe type of childhood epilepsy, that will provide greater control over seizures. Lamictal was approved for use in combination with other therapies for the treatment of Lennox-Gastaut syndrome (LGS) is a major therapeutic advance as it has been shown to provide patients with greater control of the wide range of LGS-related seizures. LGS is treated with a combination of anticonvulsants due to the multiplicity of seizures. Having this new indication with a broader spectrum of action may enable physicians to reduce the number of medications needed by some of their patients. Lennox-Gastaut syndrome is considered to be the most severe of the childhood epilepsy syndromes. It causes major disabilities and is notoriously resistant to treatment. In fact, two-thirds of patients are not satisfactorily controlled by conventional therapies. LGS usually develops in children between two and eight years of age and is characterized by frequent multiple types of seizures (anywhere from nine to 70 per day), some of which cause falls and subsequent injuries; delayed or impaired mental functioning and intellectual disability; and behavioural disturbances. "Treating Lennox-Gastaut syndrome is very challenging because there are so many different types of seizures and each child has different seizure patterns," said Dr. Sharon Whiting, a neurologist at the Children's Hospital of Eastern Ontario and the Ottawa General Hospital. "Because LGS is difficult to treat, the approval of Lamictal is important. Lamictal has been proven to significantly reduce a wider variety of seizures than medications in the past and works well in combination with other antiepileptic medications.'' Lamictal is chemically unrelated to other antiepileptic drugs (AEDs). Its mechanism of action is unknown. However, in vitro pharmacological studies suggest that its active ingredient, lamotrigine, stabilizes the membranes of neurons (brain cells) preventing the release of the excitatory amino acids, aspartate and glutamate, which are known to contribute to the excessive electrical activity in certain nerve cells that cause epileptic seizures. Lamictal has been available in Canada since 1994 as add-on therapy for the management of adult patients with epilepsy who are not satisfactorily controlled by conventional therapies and is now approved as monotherapy following polytherapy in adults, as well as add-on therapy in children and adults with LGS. In a recent double blind, placebo-controlled study involving 169 patients in 43 study sites that was published in the New England Journal of Medicine, add-on Lamictal significantly reduced the frequency of all major types of seizures in LGS patients by 32 percent versus nine percent for placebo-treated patients. Drop attacks (child suddenly loses consciousness and collapses) were significantly reduced by the addition of Lamictal (34 percent) compared to placebo (nine percent), as were tonic-clonic seizures (36 percent reduction for Lamictal versus 10 percent increase for placebo). No significant difference was seen in the occurrence of atypical absence seizures. LGS affects every aspect of a child's life and is emotionally stressful for the entire family,” Dr. Whiting said. “According to the mother of one of my patients, she was afraid to leave her son alone, since she never knew when the next seizure would occur. All she could do was to make her home as safe as possible to protect him if he fell. The use of Lamictal to treat his condition has helped to control his seizures to the point where he can now play with other children and go to school on a more regular basis.” In clinical trials, Lamictal has been shown to be well-tolerated but like all AEDs there are some side effects. According to the New England Journal of Medicine study, the most frequent adverse events reported were sore throat (14 percent) versus placebo (10 percent) and infections (13 percent) versus placebo (eight percent). Rash was reported by seven patients treated with Lamictal (nine percent) versus six patients on placebo (seven percent). Rashes in two patients treated with Lamictal were serious but resolved without complications. Lamictal should be discontinued at the first signs of a rash and the child should see a physician immediately for evaluation. Recommended dosing guidelines should be followed as more rapid initial titration has been associated with an increased risk of serious rash. Other than for the treatment of LGS, the use of Lamictal in children under 16 years of age is not recommended. A new, chewable, dispersible form of Lamictal is available in 5 mg tablets. The new tablets can be chewed, swallowed whole or dissolved in liquid for ease of administration in children. The 5 mg chewable, dispersible tablet will facilitate initiation of therapy in children. Related Links: Lamictal, Glaxo Wellcome Inc.
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