Staffers at the FDA have red-flagged their concern about cases of urinary retention tracked in some patients taking Valeant Pharmaceutical's experimental new epilepsy medicine Potiga (ezogabine), which comes before an advisory panel on Wednesday. But the staff review also noted that the drug appears to be effective and most cases of an inability to urinate were reversible.
Valeant is looking for an FDA approval to use the medicine as part of a combinational approach to partial onset seizures not adequately treated by existing remedies. And the agency spelled out its interest in the panel's views on the company's plans to monitor cases of urinary retention after it's approved for use. Valeant is developing the drug with GlaxoSmithKline and stands to gain up to half of the U.S. profits ginned by the therapy.
The FDA's Peripheral and Central Nervous System Drugs Advisory Committee will gather the day after tomorrow to vote on the drug's safety and efficacy profile, offering guidance to the agency as it ponders a final decision on the drug.