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Zogenix Submits New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for Zohydro™ for Treatment of Chronic Pain
Date:5/2/2012

SAN DIEGO, May 2, 2012 /PRNewswire/ -- Zogenix, Inc. (NASDAQ: ZGNX), a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain, announced today that the Company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Zohydro™ (hydrocodone bitartrate extended-release capsules), Zogenix's lead investigational product candidate for the treatment of chronic pain.    

Zohydro is a novel, oral, single-entity (without acetaminophen) extended-release formulation of various strengths of hydrocodone intended for administration every 12 hours  for around the clock management of moderate to severe chronic pain. If approved, Zohydro could be the first hydrocodone product to offer the benefit of less frequent dosing and the ability to treat patients with chronic pain without the risk of acetaminophen-related liver injury.  Currently, hydrocodone is only available in immediate-release, combination products, most commonly with the analgesic acetaminophen, and requires dosing every 4 to 6 hours. Zohydro, classified as a Drug Enforcement Agency (DEA) Schedule II drug product, would carry more strict prescription and dispensing rules as compared to the currently available hydrocodone combination products. In addition, Zogenix has included in the NDA a comprehensive Risk Evaluation and Mitigation Strategy (REMS) that is consistent with current FDA and industry-wide guidelines for extended-release opioid products. The REMS is intended to control inappropriate prescribing, misuse and abuse of extended-release opioids while maintaining patient access to essential pain medications.

"The NDA submission for Zohydro is a significant milestone, bringing us another step closer to making this important acetaminophen-free hydrocodone treatment option availa
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SOURCE Zogenix, Inc.
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