Zogenix Announces U.S. Food and Drug Administration (FDA) Acceptance for Review of Zohydro ER(TM) New Drug Application (NDA) for Treatment of Chronic Pain
Zohydro ER is an oral, single-entity (without acetaminophen) novel extended-release formulation of various strengths of hydrocodone intended for administration every 12 hours for continuous, around-the-clock management of moderate to severe chronic pain for an extended period of time. If approved, Zohydro ER could be the first hydrocodone product to offer the benefit of less frequent dosing and the ability to treat patients with chronic pain without the risk of acetaminophen-related liver injury. Currently, hydrocodone is only available in immediate-release, combination products, most commonly with the analgesic acetaminophen, and requires dosing every 4 to 6 hours. Based on a recent discussion with the
"We are pleased with the decision by the
The NDA submission is based on data from more than 1,100 patients with chronic pain participating in the pivotal Phase 3 efficacy study (Study 801) and an open-label Phase 3 safety study (Study 802) of Zohydro ER. Study 801 successfully met its primary efficacy endpoint, demonstrating that Zohydro ER resulted in significantly (p=0.008) improved chronic pain relief compared to placebo. The two key secondary endpoints in this study (the proportion of patients with at least 30% improvement in pain intensity and the improvement of overall satisfaction of medication) were also met. Additional study endpoints were supportive of the efficacy of Zohydro ER compared to placebo. The most commonly reported adverse events (≥2%) in the placebo-controlled pivotal Phase 3 efficacy Study 801 in opioid-experienced patients were consistent with those typically seen with chronic opioid therapy and were constipation, nausea, somnolence, fatigue, headache, dizziness, dry mouth, vomiting and pruritus. Study 802, in which patients received Zohydro ER for up to 12 months, demonstrated that the incidence of adverse events with Zohydro ER for up to 12 months was consistent with that seen in the pivotal Phase 3 efficacy study.
About Zohydro ER
Zohydro ER is an oral, single-entity, 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 single-entity hydrocodone therapy for 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 116 million people in
Chronic pain can be treated 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.
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