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Zogenix Receives FDA Approval For Zohydro(TM) ER (hydrocodone Bitartrate) Extended-Release Capsules

SAN DIEGO, Oct. 25, 2013 (GLOBE NEWSWIRE) -- Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company developing and commercializing products for the treatment of central nervous system disorders and pain, today announced that the U.S. Food and Drug Administration (FDA) has approved Zohydro TM ER (hydrocodone bitartrate) extended-release capsules, an opioid agonist, extended-release oral formulation of hydrocodone without acetaminophen, for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Zogenix expects to launch Zohydro ER in approximately four months.

Zohydro ER is the first extended-release formulation hydrocodone therapy without acetaminophen. The use of products containing acetaminophen in high doses over long periods of time has the potential for causing liver injury. Acetaminophen overdose is a leading cause of acute liver failure in the United States, with 63 percent of unintentional acetaminophen overdoses attributed to the use of hydrocodone-acetaminophen combination products. 1

"Zohydro ER fulfills a critical need among people living with chronic pain who meet the criteria for therapy with extended release opioids. It is the first extended-release hydrocodone medicine that is acetaminophen-free. Also, a significant proportion of patients on existing forms of immediate-release hydrocodone-acetaminophen combination treatments have liver disease or risk factors, and the availability of an acetaminophen-free formulation encompassing a range of hydrocodone doses is an important therapeutic option for these patients," said Dr. Srinivas Nalamachu, M.D., a pain specialist at the International Clinical Research Institute, Overland Park, Kansas and investigator in the clinical trials of Zohydro ER.

Zogenix is committed to supporting appropriate use of opioid pain treatments for patients suffering from chronic pain. Zogenix will implement the Risk Evaluation and Mitigation Strategy (REMS) for Extended Release (ER) and Long Acting (LA) Opioids required by the FDA for all the products in the class.  In addition, Zogenix will participate in the design and implementation of post-marketing studies, as recently outlined by the FDA.  NDA sponsors of ER/LA opioids are now required to conduct studies to assess the serious risks associated with long-term use.

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