BioCentury
ARTICLE | Clinical News

FDA grants breakthrough therapy designation to Zogenix's ZX008

February 9, 2018 4:18 PM UTC

Zogenix Inc. (NASDAQ:ZGNX) said FDA granted breakthrough therapy designation to ZX008 to treat seizures associated with Dravet syndrome. The designation is based on data from the Phase III Study 1 to treat Dravet syndrome showing that ZX008 met its primary endpoint of reducing mean monthly convulsive seizure frequency. Top-line data from the second Phase III trial -- Study 1504 -- of ZX008 to treat Dravet syndrome are expected next quarter, with regulatory submissions in the U.S. and EU to follow thereafter (see BioCentury, Oct. 6, 2017).

ZX008 is an oral solution of low-dose fenfluramine, a derivative of amphetamine that promotes the release of serotonin (5-HT) from neuronal storage vesicles and inhibits its reuptake...

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