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The NDA for Zogenix's fenfluramine therapy is supported by data from 2 phase 3 trials in Dravet syndrome, as well as an interim analysis from the company’s ongoing open-label extension study, which includes 232 patients treated for up to 21 months.

At the end of the 6-month, placebo-controlled treatment period, treatment with lemborexant at 5 mg or 10 mg resulted in statistically significant improvements compared to placebo in patient-reported sleep onset latency, subjective sleep efficiency, and subjective wake after sleep onset.