(464) Long-term safety and maintenance of analgesia with an extended-release hydrocodone tablet formulated with OraGuard™ technology during a 12-month open-label study in patients with chronic pain

Abstract

This 12-month, phase 3, open-label study evaluated long-term safety of an extended-release (ER) hydrocodone tablet developed with OraGuard™ technology. Eligible patients (aged 18-80 years) were rolled over from a previous 12-week, randomized, placebo-controlled study of ER hydrocodone or were newly enrolled with chronic (≥3 months) noncancer pain. After titrating ER hydrocodone (15-90 mg every 12 hours) to a successful dose, patients received up to 52 weeks of open-label treatment. Safety assessments included adverse events (AEs), serious AEs, withdrawals, and deaths. Patient global assessment (PGA) of pain control was also evaluated (assessments collected before the first titration dose in the previous study were considered baseline for rollover patients). In total, 329 patients received ≥1 ER hydrocodone dose and were evaluable for safety; mean age was 54.4 years, 79% were white, and 65% had back/low back pain. A total of 284 patients (86%) reported ≥1 AE, most commonly (>5%) constipation (26%), nausea (19%), headache (12%), somnolence (11%), vomiting (9%), and upper respiratory tract infection (8%). Twenty-seven (8%) patients experienced ≥1 serious AE (SAE); SAEs (>1 patient) included dehydration (n=2), deep vein thrombosis (n=2), renal failure (n=3), and pneumonia (n=3); none were considered treatment-related. Sixty-two (19%) patients withdrew because of treatment-emergent AEs, most commonly nausea (5%) and constipation (3%). Two deaths were reported (cause unknown, n=1; cardiac arrest and hyperkalemia, n=1); neither was considered treatment-related. Good/excellent PGA responses were reported by 20% of patients at baseline, 81% at the beginning of open-label treatment, and 75% at endpoint (last observed postbaseline data). ER hydrocodone demonstrated a safety profile consistent with the known safety profile of hydrocodone and was well-tolerated up to 12 months in patients with chronic pain, with improvements in pain control observed early and maintained through the end of the study. Sponsored by Cephalon, now a subsidiary of Teva Pharmaceuticals.