Valeant Pharmaceuticals International, an Aliso Viejo-based drug maker, said Monday that it plans to submit U.S. and European regulatory applications for an epilepsy drug candidate.
Valeant said it was going to submit applications for retigabine with the Food and Drug Administration and the European Medicines Agency by late October.
The drug maker said it and its retigabine development partner, British drug maker GlaxoSmithKline, met with the FDA in August to talk about technical aspects of the regulatory filing.
Valeant’s “pleased” with the regulatory meeting’s outcome and progress and is working to finalize its application submission, said Chief Executive J. Michael Pearson.
Valeant also said it would start a clinical trial to look at a form of retigabine that would be taken once or twice daily by patients.
Valeant got retigabine in 2005 through a $280 million buy of San Diego-based Xcel Pharmaceuticals Inc. It signed its development deal with Glaxo in 2008.
Some analysts believe much of Valeant’s fortunes rest on how retigabine does.
Since joining Valeant in 2008, Chief Executive Pearson has restructured the company through cutting jobs and selling off non-core businesses.
