Zogenix's Phase 3 efficacy study (Study 801) evaluating Zohydro (hydrocodone bitartrate) extended-release capsules has met primary endpoint.
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In the study Zohydro showed improved chronic pain relief in comparison to placebo.
Additionally, the study also met the two secondary endpoints, specifically, the proportion of patients with at least 30% improvement in pain intensity and the improvement of overall satisfaction of medication.
Zogenix president and chief operating officer Stephen Farr said the drug will offer hydrocodone for the first time in a convenient 12-hour dose while eliminating acetaminophen.
Zogenix CEO Roger Hawley said if approved, as planned, they intend to expand their sales force in order to be in a position to educate prescribers about this important new option for chronic pain management and assume a greater promotional responsibility for Sumavel DosePro.
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