Zogenix, Inc. ZGNX today announced that
the U.S. FDA Anesthetic and Analgesic Drug
Products Advisory Committee (AADPAC) will review the Company's New Drug
Application (NDA) for Zohydro™ ER (hydrocodone bitartrate extended-release
capsules) on December 7, 2012. Zohydro ER is Zogenix's lead investigational
product candidate for the management of moderate-to-severe chronic pain when a
continuous, around-the-clock opioid analgesic is needed for an extended period
of time. Details of the meeting agenda will be available in the Federal
Register.
The Prescription Drug User Fee Act (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 (DEA) Schedule II drug, subject to stricter
prescribing and dispensing rules compared to the currently prescribed
hydrocodone products. 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.
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