Home Latest Drug News News Blog Epilepsy Drug Faces Approval Delay

On December 2, 2010, the Food and Drug Administration (FDA) decided not to approve epilepsy drug, Ezogabine, even though an advisory committee unanimously voted for its approval in August 2010, after July 2010 phase III trials concluded with positive results. In one of the trials, patients on a 1,200-mg daily dose of Ezogabine experienced a median 35.2% decrease in 28-day partial seizure frequency, compared with a 29.3% decrease on the 900-mg dose, a 23.4% decrease on the 600-mg dose, and a 13.1% decrease on placebo.

With the proposed trade name Potiga, Ezogabine is an anti-convulsant manufactured by GlaxoSmithKline and Valeant Pharmaceuticals for the treatment of partial epilepsies. The FDA’s response letter to the two pharmaceutical companies cited "nonclinical reasons" as the reason for disapproval. According to the FDA, "nonclinical reasons" can refer to the lack of accuracy in marketing and/or to inaccurate language. The two companies say that they hope to have their response submitted to the FDA by early 2011.

 
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