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Valeant, GSK Gain Potiga Approval

Valeant Pharmaceuticals International and GlaxoSmithKline have received FDA approval for Potiga (ezogabine) Tablets, a potassium channel opener, as adjunctive treatment of partial-onset seizures in patients aged 18 years and older.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Valeant Pharmaceuticals International and GlaxoSmithKline have received FDA approval for Potiga (ezogabine) Tablets, a potassium channel opener, as adjunctive treatment of partial-onset seizures in patients aged 18 years and older.
    
“We are so pleased to reach such an important milestone with the U.S. approval of Potiga by the FDA,” said Susan Hall, Ph.D., head of R&D at Valeant. ”We believe this product will play a needed role in the management of partial onset seizures in appropriate patients who are uncontrolled on their current medications.”

The efficacy of ezogabine as adjunctive therapy in partial onset seizures was established in three 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.

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