Opioids in non-cancer pain: Long-term safety and effectiveness of oxymorphone ER in opioid-nanve patients with chronic pain

Abstract

This 6-month, open-label study was conducted to assess the long-term safety and effectiveness of oxymorphone extended release (ER) in opioid-naïive patients with moderate to severe chronic pain. This study included patients ≥18 years of age with moderate to severe chronic pain (≥3 months' duration) with no prior opioid use (within the past 3 months) who responded suboptimally to nonopioid analgesic treatment. Patients with an initial pain intensity score of ≥40 on a 100-mm Visual Analog Scale and a pain rating of moderate or severe on a categorical scale received 2 days of therapy with oxymorphone ER 5 mg q12h. Patients were then titrated to a stable dose of oxymorphone ER that provided meaningful pain relief (<4 on a 0 to 10 scale for 3 out of 5 consecutive days); the titration period did not exceed 21 days. Following titration, patients could decrease or discontinue use of concomitant nonopioid analgesics while being maintained with the stabilized dose of oxymorphone ER therapy for up to 6 months. Rescue medication, oxymorphone immediate release 5 mg, was available only during the maintenance period. Efficacy and tolerability assessments included average daily pain intensity, average daily dose of oxymorphone ER, rescue medication, time to stabilization, adverse events, and patient and physician global assessments. Data from this 6-month study will be presented for approximately 100 patients. Conclusions will be based upon the trial results, and the implications for clinical management and research of chronic pain will be presented. The authors are grateful to Endo Pharmaceuticals Inc. and Penwest Pharmaceuticals Co. for providing partial support for this work.