NDA and MAA for Retigabine are due to be filed in mid-2008.
Valeant Pharmaceuticals appointed Parexel to develop, coordinate, and prepare the NDA and the European MAA for its investigational compound retigabine. This candidate is a neuronal potassium-channel opener that is being studied in Phase III trials as an adjunctive treatment for partial-onset seizures in patients with epilepsy.
“Parexel’s regulatory expertise is anticipated to play a critical role in our development of retigabine,” says Wesley P. Wheeler, Valeant’s president North America and R&D. “Parexel’s global presence and long experience with NDA and MAA filings will be invaluable in the regulatory filing process for retigabine.”
Valeant anticipates filing the NDA and MAA for retigabine in mid-2008.