Retigabine, a new treatment for adult epilepsy patients with partial-onset seizures, has been accepted for review by US FDA.
US Food and Drug Administration has accepted for review the New Drug Application (NDA) seeking marketing approval for the investigational drug retigabine, a neuronal potassium channel opener for the adjunctive treatment for adult epilepsy patients with partial-onset seizures, Valeant Pharmaceuticals International announced.
In August, scientists from Valeant and its collaborative partner, GlaxoSmithKline (GSK), met with US FDA to discuss the technical aspects of the planned New Drug Application (NDA) submission.
Valeant and GSK submitted an NDA to US FDA and a Marketing Authorisation Application (MAA) to the EMEA in October 2009.
The European Medicines Agency (EMEA) confirmed on November 17, 2009 that the MAA was successfully validated thus enabling the MAA review to commence.
Valeant has also been exploring three retigabine modified release (MR) technologies will 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.
Retigabine, a first-in-class neuronal potassium channel opener, is currently in late-stage development as an adjunctive treatment for patients with partial-onset seizures. In Phase III epilepsy trials, retigabine was shown to be efficacious with a demonstrated reduction in monthly seizure rates.
In Phase III epilepsy trials, retigabine reduced seizure rates compared to patients taking placebo.
The most common adverse reactions (incidence greater than or equal to 5% and twice placebo) across all completed trials to date are dizziness, fatigue, confusional state, vertigo, tremor, coordination abnormal, diplopia (double vision), disturbance in attention, asthenia (weakness), and visual blurring.
Retigabine is also being investigated for the treatment of pain associated with postherpetic neuralgia (PHN), a painful and common complication of shingles.
In August, Valeant Pharmaceuticals International announced preliminary results from its Phase IIa proof-of-concept clinical trial of retigabine for the treatment of PHN.
As an investigational drug, retigabine has not been found by the Food and Drug Administration or any other regulatory agency to be safe or effective in the treatment of any disease or illness. It may not be commercialized in the United States unless and until US FDA has approved a NDA. Similar restrictions apply in other countries, Valeant said.
Valeant has a worldwide License and Collaboration Agreement with GlaxoSmithKline to develop and commercialize retigabine.
Valeant will collaborate with GSK on the development and marketing of retigabine in the United States, Australia, New Zealand, Canada and Puerto Rico (Collaboration Territory) and GSK has an exclusive license to develop and commercialize retigabine in countries outside of the Collaboration Territory and certain backup compounds to retigabine worldwide.
Valeant Pharmaceuticals International is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of neurology and dermatology.