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May 29, 2007

Valeant Taps Parexel to Assist with Epilepsy Drug Regulatory Applications

  • 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.



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Scientifically Studying Ecstasy

MDMA (commonly known as the empathogen “ecstasy”) is classified as a Schedule 1 drug, which is reserved for compounds with no accepted medical use and a high abuse potential. Two researchers from Stanford, however, call for a rigorous scientific exploration of MDMA's effects to identify precisely how the drug works, the data from which could be used to develop therapeutic compounds.

Do you agree that ecstasy should be studied for its potential therapeutic benefits?

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