SAN DIEGO, Feb. 26, 2013 (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 been informed by the U.S. Food and Drug Administration (FDA) that Zogenix is unlikely to receive an action letter for its New Drug Application (NDA) for Zohydro TM ER (hydrocodone bitartrate extended-release capsules) by the Prescription Drug User Fee Act (PDUFA) goal date of March 1, 2013. Under the performance goals set by the FDA under PDUFA, the agency can miss the prescribed goal date for approximately ten percent of the NDAs that are submitted each year and still meet the performance goals for review of priority and standard applications.
The FDA has not provided Zogenix with information as to the reason for the possible delay, but has indicated that the delay would likely be brief and may last only several weeks. Zogenix has not been informed of any deficiencies in the application during the review process to date.
"We are confident in the Zohydro ER program and our NDA submission and are committed to working with the FDA while it completes its review," said Stephen Farr, Ph.D., president and chief operating officer of Zogenix. "We believe there is an important medical need for an extended-release hydrocodone medicine without acetaminophen and that Zohydro ER can fill this need based on its safety and efficacy profile. We also understand the public health concerns regarding the misuse and abuse of all opioids and intend to be a proactive leader by implementing our proposed efforts to assure safe and appropriate use."If approved, Zohydro ER will be classified as a Drug Enforcement Agency (DEA) Schedule II drug, making it subject to stricter prescribing and dispensing rules, compared to the hydrocodone-acetaminophen combination products, which are classified as Schedule III drugs. The Schedule II designation recognizes the potential for abuse and dependence, and is an important measure in the effort to promote appropriate use and minimize the potential of abuse or diversion of hydrocodone products. Zohydro ER will also have a Risk Evaluation and Mitigation Strategy (REMS) consistent with the recently introduced FDA-approved REMS for Extended Release (ER) and Long Acting (LA) Opioids.