Shawshank, VA 7/16/12 (StreetBeat) – Zogenix Inc (Nasdaq: ZGNX) today announced that the U.S. Food and Drug Adminstration (FDA) has accepted for review the New Drug Application (NDA) for Zogenix’s Zohydro ERTM. Zogenix is a pharmaceutical company specializing in products that treat central nervous system disorders and pain. It’s Zohydro medication, a hydrocodone bitartrate extended-release capsule, is the company’s lead investigational product candidate for treating moderate to severe pain. The standard review of an NDA is 10 months from submission date, and the FDA assigned a target action date of March 1, 2013 for this product.
Hydrocone is currently only available in immediate-release with, most commonly, the analgesic acetaminophen, and requires dosing of 4 to 6 hours. Zohydro ER is therefore revolutionary in its position, creating the first hydrocodone product to offer less frequent dosing and the ability to treat patients without the risk of acetaminophen-related liver injury. These capsules have oral, single-entity (without acetamihophen) extended release formulas of various strengths of hydrocodone intended for administration every 12 hours to manage moderate to severe chronic pain for an extended period of time.
"We are pleased with the decision by the FDA to accept our submission for filing and look forward to working with them throughout the regulatory process," said Stephen Farr, Ph.D., president and chief operating officer of Zogenix. "If approved, Zohydro ER will be classified as a Drug Enforcement Agency (DEA) Schedule II drug, subject to stricter prescribing and dispensing rules compared to the currently prescribed hydrocodone products. In addition, the Risk Evaluation and Mitigation Strategy (REMS) for Zohydro ER will be consistent with the recently introduced FDA-approved REMS for Extended Release and Long Acting Opioids. We are supportive of these measures to reduce the inappropriate prescribing and misuse of opioid products which, by including the hydrocodone class, creates consistent controls across all extended release opioid products. The approval of Zohydro ER would allow appropriate DEA registered physicians to treat chronic pain patients using hydrocodone for moderate to severe pain while avoiding acetaminophen-related liver injury."
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