Zogenix, Inc. (ZGNX) said Friday that the U.S. Food and Drug Administration's Anesthetic and Analgesic Drug Products Advisory Committee voted 2-11, with 1 abstention, against the approval of Zohydro ER, an extended-release formulation of hydrocodone without acetaminophen, 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.
The FDA is not bound to follow its panels' recommendation while approving a drug, though it often does so.
The Prescription Drug User Fee Act date for completion of FDA review of the Zohydro ER New Drug Application for approval is March 1, 2013.
The NDA submission is based on data from over 1,100 patients with chronic pain participating in the pivotal Phase 3 efficacy study and an open-label Phase 3 safety study of Zohydro ER. The primary efficacy endpoint and two key secondary endpoints of the efficacy study in chronic low back pain patients were met.
The safety study, in which patients received Zohydro ER for up to 12 months, demonstrated that the incidence of adverse events was consistent with that seen in the efficacy study with the most commonly reported adverse events being consistent with those typically seen with chronic opioid therapy.
If approved, Zohydro ER will be classified as a Drug Enforcement Agency Schedule II drug, subject to stricter prescribing and dispensing rules compared to the currently prescribed hydrocodone products.
Zohydro ER could also be the first extended-release novel formulation hydrocodone therapy without acetaminophen for the management of chronic pain, avoiding the potential for liver injury associated with the use of acetaminophen in high doses or over long periods of time.
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