Zogenix files NDA with FDA for Zohydro Chronic Pain treatment

Zogenix has submitted an New Drug Application (NDA) to the FDA for Zohydro (hydrocodone bitartrate extended-release capsules) for the treatment of Chronic Pain. Zohydro, classified as a Drug Enforcement Agency Schedule II drug product, would carry more strict prescription and dispensing rules as compared to the currently available hydrocodone combination products. In addition, Zogenix has included in the NDA a comprehensive Risk Evaluation and Mitigation Strategy (REMS) that is consistent with current FDA and industry-wide guidelines for extended-release opioid products. The REMS is intended to control inappropriate prescribing, misuse and abuse of extended-release opioids while maintaining patient access to essential pain medications. The NDA submission is based on data from over 1,100 patients with chronic pain participating in the pivotal Phase III efficacy study (Study 801), and an open-label Phase III safety study (Study 802) of Zohydro. These demonstrated that the drug resulted in significantly (p=0.008) improved Chronic Pain relief compared to placebo and proved it was generally safe and well tolerated.