Valeant Pharmaceuticals Completes Enrollment of Second Pivotal Phase 3 Trial for Epilepsy Drug Retigabine
December 7, 2007
Medical Letter on the CDC & FDA via NewsEdge Corporation :
2007 DEC 16 - (NewsRx.com)
-- Valeant Pharmaceuticals International (NYSE:VRX) announced that it has achieved full enrollment in RESTORE2, its second pivotal Phase 3 study of retigabine in the treatment of epilepsy. Retigabine is a first-in-class neuronal potassium channel opener demonstrated to be effective in a recently published Phase 2b epilepsy study. The RESTORE1 and RESTORE2 trials (Retigabine Efficacy and Safety Trials for Partial Onset Epilepsy) 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 600 and 900 milligrams per day whereas RESTORE1 is investigating retigabine at 1,200 milligrams per day (see also Epilepsy).
"More than 50 million people worldwide have epilepsy and the global market for AEDs is more than $13 billion and growing," said Timothy C. Tyson, Valeant's president and chief executive officer. "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. We are pleased to be leading the way in the research and development of potassium channel openers for the treatment of important neurological disorders such as epilepsy and neuropathic pain."
Five hundred and thirty-nine patients have enrolled in RESTORE2, which is being conducted in 69 sites across Europe, Israel, Australia, South Africa and the United States. The RESTORE1 trial is being conducted in 49 sites across the United States, Argentina, Mexico, Brazil and Canada. To date, more than 85 percent of eligible patients involved in RESTORE trials have chosen to enter into ongoing open-label extension studies.
"Despite the availability of many new antiepileptic drugs during the last decade, more than 30 percent of people with epilepsy still suffer regular seizures," said RESTORE2 principal investigator Martin Brodie, M.D., University of Glasgow, Scotland. "With the European retigabine adjunctive trial program completely enrolled, the day is nearer when this exciting new medicine with its wholly novel mechanism of action may reach the marketplace."
Currently, there are no AEDs on the market which function by opening the neuronal potassium channel. Adding to Valeant's growing expertise with this novel therapeutic class of AEDs, the company recently announced the selection of several pre-Investigational New Drug (IND) candidates for its next-generation potassium channel opener program. Valeant expects to file an Investigational New Drug for the lead candidate, VRX698, in mid-2008.
Following the anticipated completion of the RESTORE trials in the second quarter 2008, Valeant plans to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application in Europe for retigabine with an anticipated launch in 2009.
