Policy & Regulation
Zogenix reports positive Phase 3 results in Dravet syndrome study
12 July 2018 -

Zogenix Inc (NASDAQ: ZGNX) has recorded positive top-line results in the second confirmatory Phase 3 trial of its investigational drug, ZX008 (low-dose fenfluramine hydrochloride), in children and young adults with Dravet syndrome, the company revealed on Thursday.

Dravet syndrome is a rare form of childhood epilepsy which is associated with frequent, severe convulsive seizures.

Zogenix's latest study met the primary endpoint and all key secondary endpoints, demonstrating that ZX008, at a dose of 0.5 mg/kg/day (maximum 20 mg/day), is superior to placebo when added to a stiripentol regimen.

According to the company, patients taking ZX008 achieved a 54.7% greater reduction in mean monthly convulsive seizures compared to placebo.

ZX008 also demonstrated statistically significant improvement versus placebo in both key secondary measures, including patients with clinically meaningful reductions (>50%) in seizure frequency and longest seizure-free interval.

The drug was generally well-tolerated in the study, with adverse events consistent with those observed previously and the known safety profile of fenfluramine.

ZX008 is designated as an orphan drug in both the US and Europe, and has received Breakthrough Therapy designation in the US for the treatment of Dravet syndrome.

Zogenix plans to submit applications for regulatory approval in the US and Europe in the fourth quarter of 2018.

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