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news.Valeant Pharmaceuticals International is to initiate enrollment for a large scale phase III trial of its epilepsy drug, retigabine. The drug employs a new mechanism of action, which is a potentially major advancement in the treatment of partial onset seizures.
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The phase III clinical trials for retigabine will consist of two global studies, the first in the United States, Mexico and South America with up to 45 sites, and the second in other major markets around the world with up to 60 sites. Combined enrollment in both studies is expected to be approximately 800 patients.
“Retigabine is a pipeline candidate with significant potential in the $8.7 billion epilepsy market,” Valeant’s president and chief executive officer, Timothy Tyson said. “Retigabine represents an entirely new mechanism of action for the treatment of partial onset seizures.”
Results of the two studies are anticipated to be available in the second half of 2007. Retigabine is expected to be in the market in 2008 assuming successful completion of the phase III trials and approval from the FDA.