FDA Asks Addl. Information On Zogenix' Proposed ZX008 Phase 3 Program

(RTTNews) - Zogenix, Inc. (ZGNX) announced the recent receipt of a request from the FDA for additional information related to its proposed Phase 3 program for ZX008 prior to the regulator declaring Investigational New Drug Application effective.

Zogenix said it has responded with the requested information required to initiate the clinical program. ZX008 previously received orphan drug designation from the FDA, and is expected to enter Phase 3 clinical studies during the fourth quarter of 2015 for the treatment of Dravet syndrome, a rare and debilitating form of epilepsy that begins in infancy.

Zogenix noted that FDA's specific information requests are related to normative ranges for echocardiograms being conducted during the course of the pediatric Phase 3 program, and an amended Phase 3 study protocol to reflect a required follow-up echocardiogram 3 to 6 months after patients discontinue treatment with ZX008.