Phase III data for retigabine – potassium channel opener in development for epilepsy

[News Feeder14]

BioSpace has reported briefly on Phase III data for retigabine, a first-in-class neuronal potassium channel opener which is in development as an adjunct in the treatment of adult epilepsy patients with refractory partial-onset seizures.

The double-blind trial – RESTORE 1 (Retigabine Efficacy and Safety Trials for Partial Onset Epilepsy) – randomised 306 adults who were experiencing refractory partial-onset seizures despite receiving stable doses of up to three anti-epileptics to additional treatment with retigabine (400mg TDS; n=151) or placebo (n=150). Study duration was 32 weeks including 8 weeks baseline phase, 6 weeks titration phase, 12 weeks maintenance phase and 6 weeks transition phase. Only brief details of the study are included in the BioSpace abstract which prevents a full evaluation of the findings; however the following results were reported:

• The median reduction in 28-day total partial seizure frequency was 44.3% in the retigabine group and 17.5% in the placebo group (p<0.0001)

• The median reduction in 28-day total partial seizure frequency during the maintenance phase was 54.5% versus 18.9%, respectively (p<0.0001)

• The responder rate (at least a 50% reduction in 28-day total partial seizure frequency) was 45.0% versus 18.0%, respectively (p<0.0001)

• The responder rate during the maintenance phase was 55.5% versus 22.6%, respectively (p<0.0001)

Results from RESTORE 2, the second pivotal Phase III clinical trial studying lower doses of retigabine, are expected during the second quarter of 2008. The company anticipate filing a Marketing Authorization Application (MAA) to the EMEA before the end of the year.
More...