Valeant completes Phase III enrollment for retigabine

Retigabine is a first-in-class neuronal potassium channel opener demonstrated to be effective in a recently published Phase IIb epilepsy study. The RESTORE1 and RESTORE2 (retigabine efficacy and safety trials for partial onset epilepsy) trials are designed to evaluate the efficacy and safety of retigabine as an adjunctive therapy in patients with refractory partial-onset seizures who are receiving one, two or three concomitant antiepileptic drugs (AEDs). RESTORE2 is investigating retigabine at 600mg and 900mg per day whereas RESTORE1 is investigating retigabine at 1,200mg per day.

A total of 539 patients have enrolled in RESTORE2, which is being conducted in 69 sites across Europe, Israel, Australia, South Africa and the US. The RESTORE1 trial is being conducted in 49 sites across the US, Argentina, Mexico, Brazil and Canada. To date, more than 85% of eligible patients involved in RESTORE trials have chosen to enter into ongoing open-label extension studies.

Timothy Tyson, Valeant’s president and CEO, said: “More than 50 million people worldwide have epilepsy and the global market for AEDs is more than $13 billion and growing. The development of retigabine, which will be the first and only potassium channel opener for the treatment of refractory epilepsy, is our highest R&D priority at Valeant.”