First Approval For Novo Nordisk's Tiagabine

Novo Nordisk's new antiepileptic drug Gabitril (tiagabine) has been approved in France, its first market. The product is indicated for add-on treatment in patients over the age of 12 with partial seizures, with or without secondary generalization. Further European approvals are expected before the end of the year.

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 GABA from the synapse, making it available to produce its effect for longer, and thereby restrict the uncontrolled discharge of neurons associated with abnormal depolarization characteristic of epilepsy. The molecule contains a sugar fragment within its structure which enhances its uptake into the CNS. Tiagabine is the first of these GABA reuptake inhibitors to be approved for marketing, according to Novo Nordisk.

Novo and its collaborators have conducted five add-on, placebo-controlled trials and six non-comparative, open-label studies at centers in Europe, the USA and Australia. These studies included 2,261 patients with epilepsy that was poorly controlled with their existing medication. This is a relatively common scenario in epilepsy, with many patients needing to try multiple compounds, alone and in combination, before they find a regimen which controls their symptoms. Some patients remain refractory to all drugs, which is why there is a real need for new drugs acting via novel mechanisms.