FDA Advisory Committee Reviewing Zohydro ER New Drug Application
Zogenix to Host Conference Call at 6:30 pm ET Today
SAN DIEGO, Dec. 7, 2012 (GLOBE NEWSWIRE) -- Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain, announced that NASDAQ halted trading of the company's common stock on December 7, 2012. The U.S. Food and Drug Administration's (FDA) Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) is meeting today to review the Company's New Drug Application (NDA) for Zohydro ER (hydrocodone bitartrate extended-release capsules).
Conference Call & Webcast
Zogenix will host a conference call to discuss the outcome of the AADPAC meeting today, Friday, December 7, 2012 at 6:30 p.m. ET (3:30 p.m. PT). To participate, please dial (800) 299-9086 (U.S.) or (617) 786-2903 (International); participant passcode: 21970283. To access the live webcast please visit the Zogenix Investor Relations website at http://ir.zogenix.com.
The conference call will be hosted by Chief Executive Officer Roger L. Hawley and President and Chief Operating Officer Stephen J. Farr, Ph.D.
A replay of the conference call will be available beginning December 7, 2012 at 8:30 p.m. ET (5:30 p.m. PT) until December 14, 2012, by dialing (888) 286-8010 (U.S.) or (617) 801-6888 (International); passcode: 27116437. A replay of the webcast will also be accessible on the Investor Relations website for one month, through January 10, 2013.
About Anesthetic and Analgesic Drug Products Advisory Committee
The AADPAC reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human anesthetic and analgesic drug products and makes appropriate recommendations to the Commissioner of Food and Drugs. The AADPAC provides FDA with independent expert advice and recommendations, however, the final decision regarding approval is made by FDA.
Zogenix, Inc., with offices in San Diego and Emeryville, California, is a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain. Zogenix's first commercial product, SUMAVEL® DosePro® (sumatriptan injection) Needle-free Delivery System, was launched in January 2010 for the acute treatment of migraine and cluster headache. Zogenix's lead investigational product candidate, ZohydroTM ER (hydrocodone bitartrate) is an oral, novel extended-release formulation of various strengths of hydrocodone without acetaminophen intended for administration every 12 hours for around the clock management of moderate to severe chronic pain. Zogenix's second DosePro investigational product candidate, ReldayTM, is a proprietary, long-acting injectable formulation of risperidone for the treatment of schizophrenia. In May 2012, Zogenix submitted to the FDA a New Drug Application for Zohydro ER and an Investigational New Drug Application for Relday. The FDA assigned a PDUFA target action date of March 1, 2013 for the Zohydro ER NDA.
For additional information, please visit www.zogenix.com.
SUMAVEL ®, DosePro ®, ReldayTM and ZohydroTM ER are trademarks of Zogenix, Inc.
Zack Kubow | The Ruth Group
646.536.7020 | [email protected]
Emily Poe | WCG
212.301.7183 | [email protected]