Zogenix announced that its investigational Lennox Gastaut Syndrome (LGS) treatment, ZX008 (low-dose fenfluramine) liquid solution, has been granted Orphan Drug designation by the Food and Drug Administration (FDA).
In April, the FDA approved the Investigational New Drug (IND) Application for ZX008, allowing for the initiation of a Phase 3 study of ZX008 in patients with LGS. The drug is currently being assessed in a separate Phase 3 trial in patients with the rare pediatric epilepticcondition, Dravet syndrome, for which it has gained Fast Track status.
The Company is awaiting top-line results of the current trial before initiating the LGS study. “We expect that the first patients will enroll in the planned LGS study in the fourth quarter of 2017,” said Stephen J. Farr, PhD, President and CEO of Zogenix. Top-line date from the Dravet syndrome trial is expected to emerge in the third quarter of 2017.
Orphan Drug Designation is intended to expedite the process by offering assistance with study designs and development, and also provides 7 years market exclusivity following approval.
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