Zogenix, Inc. Completes Zohydro(TM) Pre-NDA Meetings With FDA

SAN DIEGO, Dec. 20, 2011 (GLOBE NEWSWIRE) -- Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain, today announced that it has concluded its pre-New Drug Application (NDA) meetings with the U.S. Food & Drug Administration (FDA) related to its lead investigational product candidate, Zohydro™ (hydrocodone bitartrate extended-release capsules). The purpose of the meetings was to discuss the non-clinical, clinical and Chemistry, Manufacturing and Controls (CMC) development of Zohydro, and to agree on the submission requirements for the NDA submission under 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. After a detailed review of the submission timeline, Zogenix plans to submit the NDA for Zohydro early in the second quarter of 2012.