Presented at the 2012 AAPM Annual Meeting « Back

An Open-Label Study to Evaluate the Efficacy and Safety of Extended-Release Hydromorphone (OROS® Hydromorphone ER) in Patients with Chronic Neuropathic Pain

Srinivas Nalamachu, MD, nalamachu@yahoo.com¹, Donna Ruck, ARNP¹, Christy Akright, CMA¹, Sam Fasbinder¹, Ritvik Bansal¹, (1) International Clinical Research Institute, Leawood, Kansas

Introduction: This single-center, open-label, 12-week study examined the efficacy and safety of once-daily hydromorphone extended-release tablets (OROS® hydromorphone ER) in patients with chronic neuropathic pain. Materials and Methods: Opioid-tolerant patients were converted from their previous opioid and titrated to adequate analgesia with OROS hydromorphone ER over 2 weeks. The primary efficacy measure was change from baseline on question #5 (“average pain”) of the Brief Pain Inventory (BPI) scale, assessed at Week 12. The Pain Quality Assessment Scale (PQAS) and the Global Assessment of Treatment Satisfaction (GATS) were included as secondary endpoints. All patients provided written informed consent; this study received approval from an Institutional Review Board. Results: Overall, 30 patients (mean age, 58; 67% male; mean daily morphine equivalent dose: 163.7 mg) were enrolled and received ≥1 dose of OROS hydromorphone ER. Patients were initially converted to a mean daily OROS hydromorphone ER dose of 18.1 mg and subsequently titrated to a mean daily dose of 26.4 mg. BPI “average pain” decreased from 5.7 at baseline to 4.5 at Week 12. The PQAS decreased from 104 at baseline to 79 at Week 12. The majority of patients (73%) were either very satisfied or satisfied with their treatment. The most common adverse events were dizziness (four patients), headache (two patients), and nausea (two patients). No serious adverse events were reported. Conclusions: These findings indicate that patients with chronic neuropathic pain can be safely and effectively converted and maintained on hydromorphone ER. Additional placebo-controlled studies are needed in this patient population.

Funding: None