Zogenix Provides Update on FDA Advisory Committee Meeting for Zohydro(TM) ER for Management of Chronic Pain
The Prescription Drug User Fee Act (PDUFA) date for completion of
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 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
Conference Call Details
A replay of the conference call will be available beginning
About Zohydro ER
Zohydro ER is an 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. If approved, Zohydro ER could 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.
Zohydro ER uses
About Chronic Pain
Chronic pain is defined as ongoing or recurrent pain that adversely affects an individual's well-being. An estimated 100 million people in
Chronic pain can be managed with both immediate-release and extended-release opioids. Currently marketed hydrocodone products are only immediate-release and contain an analgesic combination ingredient, primarily acetaminophen. Acetaminophen may cause liver injury when used in high dosages, over long periods of time or in accidental overdoses due to multiple acetaminophen products being taken at once.
For additional information, please visit www.zogenix.com.
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