Drug giant GlaxoSmithKline has launched its new epilepsy medicine Trobalt in the UK, which is designed to help patients with epilepsy get better control of their seizures.
The move follows the green light from the European Commission in March, which approved the use of Trobalt (retigabine) as an add-on therapy for partial onset seizures with or without secondary generalisation in adult patients with epilepsy.
European approval came on the back of results from two pivotal Phase III studies (RESTORE 1 and 2), which showed that the drug significantly improved seizure control, with a greater number of patients achieving a reduction in the number of seizures by 50% or more, compared with placebo.
Around one-third of patients with epilepsy continue to experience seizures despite treatment, which equates to around 60,000 in the UK, underscoring the need for new effective treatment options to help better manage the condition, and it is hoped that Trobalt will help to address some of this unmet need.
According to Professor Martin J Brodie, director of the Epilepsy Unit at the Western Infirmary, Glasgow, uncontrolled epilepsy is associated with "substantial limitations to quality of life, an increased risk of sudden death and significant costs to the affected individual, to society and to the healthcare system," and he considers Trobalt to be "a positive addition to the therapeutic armamentarium for the many adult patients with inadequately-controlled focal onset seizures”.
First in class, safety issues
Trobalt is the first and currently only anti-epileptic drug to target potassium channels involved in inhibitory mechanisms in the brain, which are thought to have a role in seizure control.
However, on a safety note, because of observations in clinical trials regulators have recommended that the drug is used with caution in patients at risk of urinary retention.
And because of potential interference with the heart's electrical activity, ECGs must be carried out in patients taking any medication that may interfere with this, in those who may have congestive heart failure, ventricular hypertrophy, hypokalaemia or hypomagnesaemia, and in those aged 65 years and above.