Potiga (ezogabine) Receives FDA Approval

Valeant Pharmaceuticals International Inc.(Meda’s partner for ezogabine - known as retigabine outside of the U.S.) has received approval from the U.S.FDA for Potiga(ezogabine).

Potiga is approved for adjunctive treatment for adults with partial-onset seizures. It is the first approved potassium channel opener for this indication.

                                                            Retigabine (INN) or ezogabine (USAN)

The efficacy of ezogabine as adjunctive therapy in partial onset seizures was established in 3 controlled clinical studies involving 1,239 adult patients.

The primary endpoint was percent change in seizure frequency from baseline in the double-blind treatment phase.

Outside of the U.S., ezogabine is known as retigabine (brand name Trobalt), and received marketing authorization in the European Union (EU) on March 28th 2011.

Valeant and GSK had been working on the drug jointly and this drug is believed to play a needed role in the management of partial onset seizures in patients who are uncontrolled on their current medications.

Posted in: ezogabine,Potiga,retigabine,valeant