An advisory panel of 13 federal health experts, appointed by FDA, has voted in favour of the effectiveness of the epilepsy drug Potiga (generic name ezogabine), developed jointly by GlaxoSmithKline and Valeant Pharmaceuticals.
The panel members based their decision on the clinical trial presented by the North American Company Valeant and told that the drug can be an effective treatment for the patients suffering with epilepsy, a disease that causes frequent seizures.
The Company held their trials on 1,241 patients. Those who were given a 1,200-mg daily dose for 28 days showed a median 35.2% reduction in seizure frequency, while the results showed a 29.3% decrease on taking the 900-mg dose, and the 600-mg dose decreases the frequency of seizures by 23.4%. Those who were put on placebo had seizure reduction by 13.1%.
The drug was examined against urinary problems in human trials, which were found during the trials on animals. Of those who took ezogabine, 1% got affected with urinary retention, while 2% got affected with urinary faltering. Only in four patients, the severe consequences of the drug were found.
Along with the presentation of the plan, the Company also attached the risk management plan for avoiding the side-effects of the drug.
Though, the panel has approved the effectiveness of the drug, but it is still concerned about the monitoring of the problems like urinary retention that it poses.
The panel is likely to decide the fate of commercialization of the drug on August 30.