Zogenix (NASDAQ:ZGNX) reports that the last subject has been randomized in its Phase 3 clinical trial, Study 1, assessing lead product candidate, Fast Track-tagged ZX008, for the treatment of Dravet syndrome. The estimated completion date is September 1.
The company is also conducting another Phase 3, Study 1504, where participants are receiving standard-of-care treatment of stiripentol, valproate and clobazam as baseline. According to ClinicalTrials.gov, the estimated study completion date is August.
ZX008 is a low-dose fenfluramine. It was the "Fen" component of the anti-obesity medication Fen-phen that was withdrawn from the U.S. market in 1997 due to its association with heart valve disease. It has Orphan Drug status in the U.S. for Lennox-Gastaut syndrome and Fast Track status for Dravet syndrome.