Zohydro ER (Extended-Release Hydrocodone) – FDA Accepts New Drug Application for Review

Karen Lee Richards Health Guide
  • On Monday, the pharmaceutical company Zogenix, Inc. announced the FDA had accepted for review their New Drug Application (NDA) for Zohydro ER™ (hydrocodone bitartrate extended-release capsules).


    Hydrocodone is one of the most frequently prescribed opioid drugs for the management of moderate to severe chronic pain. There are, however, two features that set Zohydro ER apart from other hydrocodone products currently available:

    • It does not contain acetaminophen.

    • It is an extended-release medication.


    Other hydrocodone medications currently available (like Vicodin and Lortab) all contain acetaminophen, which can be hard on the liver. They are also all immediate-release, meaning they have to be taken every four to six hours. Zohydro is intended to be administered every 12 hours to provide round-the-clock pain management for an extended period of time.

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    Under the Prescription Drug User Fee Act, the goal for a standard review of an NDA is 10 months from NDA submission. The FDA has assigned a target action date of March 1, 2013 for the Zohydro ER NDA. If all goes well, a year from now an extended-release hydrocodone product may be on the market.


    "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."


Published On: July 19, 2012