Valeant Pharmaceuticals has provided update on the regulatory applications to the FDA and the European Medicines Agency (EMEA) for the investigational drug retigabine, a neuronal potassium channel opener for the adjunctive treatment for adult epilepsy patients with partial-onset seizures.
The company said that Scientists from Valeant and its collaborative partner, GlaxoSmithKline (GSK), met with the FDA in August to discuss the technical aspects of the planned New Drug Application (NDA) submission.
The file is now being finalised based on the outcome of this discussion, as well as a final review of data and documents. Valeant and GSK expect to submit an NDA to the FDA on or before October 23, 2009 and to submit a Marketing Authorisation Application (MAA) to the EMEA on October 30, 2009.
Valeant also announced that three retigabine modified release (MR) technologies would be assessed in a phase I clinical study commencing in September. The purpose of the study is to evaluate these candidate formulations to identify a lead MR compound that will be advanced in further research intended to support a product with either a once or twice-daily dosing regimen.
Michael Pearson, chairman and chief executive officer of Valeant, said: “We are pleased with the outcome of the meeting with FDA and the progress we have made. We are confident in our dossier and we are diligently working to finalize the regulatory submissions which are based on positive results from two large phase III trials.
“In addition, we are excited to have reached a key milestone in the MR development program. With three potential MR technologies under evaluation, we will soon be in a position to determine which MR formulation we intend to pursue as a once or twice-a-day option for patients continuing to suffer from epilepsy seizures.”