Effectiveness and Safety of Once-Daily Extended-Release Hydrocodone in Individuals Previously Receiving Immediate-Release Oxycodone for Chronic Pain.

Objectives: This study evaluated the safety and effectiveness of a once-daily, single-entity, extended-release hydrocodone bitartrate (HYD) among patients with chronic noncancer and non-neuropathic pain who required opioid rotation from a previous analgesic regimen that primarily consisted of immediate-release (IR) oxycodone. Methods: Post hoc analyses of a primary study that assessed HYD 20 to 120 mg over a 52-week period are presented. The primary study included a dose titration period (up to 45 days), a 52-week maintenance period, and an optional taper period (up to 14 days). Results: Relative to baseline, mean "average pain over the last 24 hours" declined by 1.9 points at the end of the titration period and by 2.6 points at the end of the maintenance period. Additionally, interference and severity of pain as measured by the Brief Pain Inventory-Short Form decreased by 2.3 and 1.9 points, respectively, during the maintenance period. The use of supplemental opioid analgesics decreased. Most patients remained on a stable HYD dose throughout the maintenance period. Most patients indicated satisfaction with HYD and considered it convenient and easy to use. HYD demonstrated a safety profile typical of µ opioids; nausea, constipation, vomiting, and dizziness were the most frequently reported opioid-related adverse events during the study. Conclusions: In patients with chronic pain who received HYD over a 52-week period, treatment was generally well tolerated and provided effective analgesia among those who rotated from a pain regimen primarily consisting of IR oxycodone.

Long-term effectiveness and safety of once-daily, single-entity, extended-release hydrocodone in patients of ≥75 years of age with moderate to severe nonmalignant and nonneuropathic pain.

In elderly (≥75 years) individuals, age-associated physiologic changes and a higher prevalence of comorbidities, polypharmacy, and increased susceptibility to medication-induced side effects complicate pain management. Hysingla® ER (HYD) is a once-daily, single-entity, extended-release hydrocodone formulation approved for the treatment of chronic pain that is insufficiently controlled by alternative treatments. In this post-hoc analysis of a previously reported study, the effectiveness and safety of HYD for the treatment of moderate-to-severe chronic pain among the elderly (≥75 years) for a 52-week duration was investigated. HYD dose administered during the maintenance period-remained relatively stable and provided clinically meaningful decreases in mean "pain over the last 24 h" and pain interference scores. Patients achieved pain control without additional non-study opioid use at the end of the study. Adverse events were typical of opioids. In summary, HYD provided clinically meaningful reduction of pain scores in elderly patients that were maintained over a 52-week period.

Efficacy and Safety of Once-Daily Extended-Release (ER) Hydrocodone in Individuals Previously Receiving ER Morphine for Chronic Pain.

OBJECTIVES: This post hoc analysis examined the effectiveness and safety of hydrocodone bitartrate (HYD) in patients with moderate-to-severe chronic pain who were previously taking extended-release morphine (morphine ER) for pain management. STUDY DESIGN: The primary analysis was an open-label, 12-month study. SETTING: The study was conducted in 88 sites in the United States. METHODS: The study was approved by an institutional review board. Eligible patients were enrolled and titrated to a once-daily dose of HYD 20, 40, 60, 80, or 120 mg for a 45-day period. The subgroup of patients in this report was using morphine ER prior to study entry. After achieving a stable HYD daily dose, patients entered a 12-month maintenance period during which additional dose adjustment could be made and nonopioid or short-acting opioid medications could be received. Average pain over the last 24 hours was recorded daily (on a scale of 0 to 10) Patients completed the Brief Pain Inventory (BPI) short form, which assessed pain severity and the interference of pain in daily life, every 4 weeks during the maintenance period. Safety was assessed routinely. RESULTS: Of the 26 patients who switched from morphine ER to HYD, 19 entered the maintenance period. At study entry, mean "average pain over the last 24 hours" was scored as 5.21. This was reduced to 3.90 by the time patients entered the maintenance phase; this level of pain control was maintained over the 12-month period, with 16 patients requiring no further HYD dose adjustment. BPI scores decreased for both pain severity and pain interference during the maintenance period. HYD was well tolerated. CONCLUSIONS: The results of this subgroup analysis suggest that rotation from morphine ER to once-daily HYD in patients with moderate-to-severe chronic pain maintains or improves pain relief and does not increase safety concerns.