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The Food and Drug Administration has declined to approve ezogabine, an investigational epilepsy medication intended as an adjunctive therapy for adults with partial-onset seizures.
The agency’s Center for Drug Evaluation and Research issued a Complete Response Letter to GlaxoSmithKline and Valeant Pharmaceuticals International Inc., citing "nonclinical reasons" for the denial of approval, according to a statement released by GlaxoSmithKline. The two companies say they are evaluating the letter and plan to address the issues cited in the letter, aiming to respond to the FDA in 2011.
In August, an FDA advisory panel agreed that ezogabine had been shown to be effective but recommended that patients treated with the drug be closely monitored for the development of urinary retention. The agency’s Peripheral and Central Nervous System Drugs Advisory Committee agreed by an 11 to 0 vote, with 2 abstentions, that the drug’s risk of urinary retention could be addressed by monitoring patients and educating clinicians about how to properly evaluate patients for changes in urinary symptoms.
None of the panel members thought that the urologic or other safety issues associated with ezogabine should keep the drug from being approved as an epilepsy medication. The panel was not asked to vote specifically on whether to recommend approval. If ezogabine is eventually approved, Valeant plans to market it as Potiga.
The Food and Drug Administration has declined to approve ezogabine, an investigational epilepsy medication intended as an adjunctive therapy for adults with partial-onset seizures.
The agency’s Center for Drug Evaluation and Research issued a Complete Response Letter to GlaxoSmithKline and Valeant Pharmaceuticals International Inc., citing "nonclinical reasons" for the denial of approval, according to a statement released by GlaxoSmithKline. The two companies say they are evaluating the letter and plan to address the issues cited in the letter, aiming to respond to the FDA in 2011.
In August, an FDA advisory panel agreed that ezogabine had been shown to be effective but recommended that patients treated with the drug be closely monitored for the development of urinary retention. The agency’s Peripheral and Central Nervous System Drugs Advisory Committee agreed by an 11 to 0 vote, with 2 abstentions, that the drug’s risk of urinary retention could be addressed by monitoring patients and educating clinicians about how to properly evaluate patients for changes in urinary symptoms.
None of the panel members thought that the urologic or other safety issues associated with ezogabine should keep the drug from being approved as an epilepsy medication. The panel was not asked to vote specifically on whether to recommend approval. If ezogabine is eventually approved, Valeant plans to market it as Potiga.
The Food and Drug Administration has declined to approve ezogabine, an investigational epilepsy medication intended as an adjunctive therapy for adults with partial-onset seizures.
The agency’s Center for Drug Evaluation and Research issued a Complete Response Letter to GlaxoSmithKline and Valeant Pharmaceuticals International Inc., citing "nonclinical reasons" for the denial of approval, according to a statement released by GlaxoSmithKline. The two companies say they are evaluating the letter and plan to address the issues cited in the letter, aiming to respond to the FDA in 2011.
In August, an FDA advisory panel agreed that ezogabine had been shown to be effective but recommended that patients treated with the drug be closely monitored for the development of urinary retention. The agency’s Peripheral and Central Nervous System Drugs Advisory Committee agreed by an 11 to 0 vote, with 2 abstentions, that the drug’s risk of urinary retention could be addressed by monitoring patients and educating clinicians about how to properly evaluate patients for changes in urinary symptoms.
None of the panel members thought that the urologic or other safety issues associated with ezogabine should keep the drug from being approved as an epilepsy medication. The panel was not asked to vote specifically on whether to recommend approval. If ezogabine is eventually approved, Valeant plans to market it as Potiga.