GlaxoSmithKline in Research Triangle Park, North Carolina and Valeant Pharmaceuticals International in Aliso Viejo, California announced that a U.S. Food and Drug Administration (FDA) advisory committee voted that clinical studies offered substantial evidence of the effectiveness of the companies’ drug ezogabine as an added treatment for adults with partial-onset seizures.
The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee reviewed effectiveness data from three studies of ezogabine and an integrated safety data base including all patients who had at least one dose of ezogabine. Overall, ezogabine, as an adjunctive therapy at a daily dose of 600, 900 or 1200 mg, reduced the median number of partial-onset seizures in adults with epilepsy not adequately controlled on one to three accompanying anti-epileptic drugs compared to a standard therapy placebo.
The FDA also asked the advisory committee to comment on risks associated with urinary retention. After a review of the safety data, including urinary retention, infection and kidney stones, a majority of committee members voted that urinary retention could be mitigated by patient monitoring and discussed how this could be addressed. The committee also voted that monitoring should not be instituted for infection and kidney stones.
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