Zogenix (NASDAQ:ZGNX) announces positive results from a third Phase 3 clinical trial, Study 3, evaluating Fintepla (fenfluramine) for the treatment of seizures associated with Dravet syndrome, a rare and severe type of childhood epilepsy. The results were consistent with the results in Studies 1&2.
The trial met the primary endpoint demonstrating a statistically significant 64.8% greater reduction in mean monthly convulsive seizures compared to placebo (p<0.0001).
Study 3 will support a marketing application in Japan, expected to be filed in 2021.
The FDA approved the drug in June for Dravet.
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