(+) Zogenix completes Zohydro pre-NDA meetings with FDA (Globenewswire) - Dec 20, 2011 - 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; Zohydro NDA submission is on track and expected in Q2 2012
Anticipated NDA submission • Pre-NDA discussions • Pain
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Zohydro NDA submission on track
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.
Stephen Farr, PhD, president and chief operating officer of Zogenix, said, "The completion of our pre-NDA meetings with the FDA brings us one more important step closer to potentially gaining approval for Zohydro. We appreciate the informative interactions, timeliness, and clarity provided by the FDA, as well as the full support of Alkermes, our CMC partner, in the pre-NDA meeting process."
Zohydro is being evaluated for the management of moderate to severe chronic pain in patients requiring continuous around-the-clock opioid therapy for an extended period of time. If approved, Zohydro could be the first extended-release hydrocodone therapy available without acetaminophen, which is associated with an increased risk of liver toxicity when used in high doses over time.
Hydrocodone pain products represent the largest prescription drug category in the United States, with over 128 million prescriptions filled in 2010. The Company believes Zohydro's ability to provide consistent 12-hour pain relief, without exposure to acetaminophen, will position the product well in this large market.
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