Promising Efficacy And Safety Results For Tiagabine

3 September 1995

New data coming from Phase III studies of tiagabine show that the drug reduced partial seizures in 30%-40% of enrolled refractory epileptic patients by 50% or more, and that only 15.3% of patients treated with the product experienced serious adverse side effects. Tiagabine is being jointly developed by Novo Nordisk, which holds its patent, and Abbott Laboratories.

Tiagabine is believed to exert its effect by prolonging the action of gamma-amino butytric acid (GABA), the primary inhibitory neurotransmitter of the central nervous system, by inhibiting the re-uptake of the compound from the synapse to make it available to produce its effect for longer, and as such restrict the uncontrolled discharge of neurons associated with abnormal depolarization characteristic of epilepsy.

The findings, reported at the recent International Epilepsy Conference held in Sydney, Australia, represent the results of five add-on placebo-controlled trials and six non-comparative, open-label, long-term, multicenter trials (ongoing), carried out in Europe, the USA, and Australia. These enrolled 2,600 patients (refractory epileptics who mostly had experienced at least six partial-onset seizures in the preceding eight weeks while on one to three standard antiepileptic drugs) and tested for efficacy and safety.

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