Zogenix, Inc. (ZGNX) announced that the U.S. Food and Drug Administration, or FDA, has accepted for review the New Drug Application, or NDA, for Zohydro ER (hydrocodone bitartrate extended-release capsules). Zohydro ER is Zogenix's lead investigational product candidate for the treatment of moderate to severe chronic pain.
The goal for a standard review of an NDA is ten months from NDA submission, and the FDA has assigned a target action date of March 1, 2013 for the Zohydro ER NDA.
Zogenix stated that the NDA submission is based on data from above 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, showing that Zohydro ER resulted in significantly improved chronic pain relief versus 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.
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