The FDA has approved Potiga (ezogabine tablets; Valeant and GlaxoSmithKline) as adjunct treatment for partial-onset seizures in adults. This approval was based on data from three controlled clinical studies involving 1,239 patients. The primary endpoint was the percent change in seizure frequency from baseline in the double-blind treatment phase. The FDA has determined that a Risk Evaluation and Mitigation Strategy (REMS) will be necessary for Potiga, with the goal of informing healthcare professionals of the risk of urinary retention and the symptoms of acute urinary retention. The FDA has recommended that Potiga be scheduled as a controlled substance under the Controlled Substances Act. Final classification is still under review by the Federal Drug Enforcement Administration and Potiga will not be available until this process is complete.
Potiga is a potassium channel opener approved for adjunctive treatment of partial onset seizures in patients ≥18 years.
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