Valeant to submit epilepsy treatment to FDA for review
ALISO VIEJO, Calif. A specialty pharmaceutical company announced an update on its new drug application for an epilepsy treatment.
Valeant Pharmaceuticals International and its collaborative partner, GlaxoSmithKline, said that its investigational drug retigabine, will be submitted to the Food and Drug Administration for review Oct. 23.
Valeant met with the FDA in August to discuss the technical aspects for the new drug application.
Retigabine is an adjunctive treatment for treating adult epilepsy patients with partial-onset seizures.
Valeant also announced that three retigabine modified release technologies will be assessed in a Phase 1 clinical study commencing this month. 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.
"We are pleased with the outcome of the meeting with FDA and the progress we have made," stated J. Michael Pearson, Valeant chairman and CEO. "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 3 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."