FDA Panel Rejects Painkiller Drug
Zogenix, Inc. recently announced that the US FDA Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) voted 2 to 11 (with one abstention) against the approval of Zohydro ER (hydrocodone bitartrate extended-release capsules), 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.
“Zogenix recognizes and appreciates that prescription opioid misuse and abuse is a critical issue,” said Stephen Farr, PhD, President and Chief Operating Officer of Zogenix. “However, it is also important to remember that there is a documented patient need for an extended-release hydrocodone medicine without acetaminophen. We remain confident in the measures we have proposed to support safe use of Zohydro ER and are committed to continuing to work with the FDA through the review process to bring this treatment option to this specific patient population.”
The Prescription Drug User Fee Act (PDUFA) date for completion of FDA review of the Zohydro ER New Drug Application (NDA) for approval is March 1, 2013. The AADPAC provides the FDA with independent expert advice and recommendations, but the final decision regarding approval of a medication is made by the FDA.
The NDA submission is based on data from over 1,100 patients with chronic pain participating in the pivotal Phase III efficacy study and an open-label Phase III 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, and the most frequent treatment emergent adverse events were constipation, nausea, somnolence, and headache. 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 (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.
Zogenix, Inc., with offices in San Diego and Emeryville, CA, is a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain. For more information, visit www.zogenix.com.
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