Zogenix Inc. (ZGNX) announced Thursday that the U.S. Food and Drug Administration's or FDA Anesthetic and Analgesic Drug Products Advisory Committee or AADPAC will review the company's New Drug Application or NDA for Zohydro ER (hydrocodone bitartrate extended-release capsules) on December 7, 2012.
The Prescription Drug User Fee Act or PDUFA date for completion of the review by the FDA is March 1, 2013. If approved, Zohydro ER will be classified as a Drug Enforcement Agency or DEA Schedule II drug, subject to stricter prescribing and dispensing rules compared to the currently prescribed hydrocodone products.
Zogenix noted that it has included in the NDA a comprehensive Risk Evaluation and Mitigation Strategy or 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.
Zohydro ER is an investigational oral, novel extended-release formulation of hydrocodone without acetaminophen for the management of moderate to severe chronic pain in patients requiring continuous, around the clock opioid therapy for an extended period of time.
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