(438) A 24-week extension of an open-label, long-term safety study evaluating the safety and effectiveness of once-daily, single-entity, hydrocodone in patients with chronic nonmalignant and non-neuropathic pain

Abstract

HYD is a once-daily, single-entity hydrocodone bitartrate tablet formulated with abuse-deterrent properties that is under development for treatment of moderate-to-severe chronic pain. This 24-week extension of a long-term, open-label study with a 12-month maintenance period characterized the safety, effectiveness, and impact on quality of life (QoL) measures of HYD (20, 40, 60, 80, 120 mg/day) treatment in patients with moderate-to-severe chronic non-malignant and non-neuropathic pain. Evaluations included adverse events (AEs), aberrant drug behaviors, audiologic and clinical laboratory assessments, ECGs, average daily pain scores, the Brief Pain Inventory, the Short Form-36, and the MOS-Sleep-revised.