Long-term tolerability and effectiveness of oxymorphone extended release in patients with cancer

Neal E. Slatkin, MD; Michelle I. Rhiner, RN, MSN, NP; Errol M. Gould, PhD; Tina Ma, PhD; Harry Ahdieh, PhD

doi:10.5055/jom.2010.0016

Authors

Neal E. Slatkin, MD
Michelle I. Rhiner, RN, MSN, NP
Errol M. Gould, PhD
Tina Ma, PhD
Harry Ahdieh, PhD

DOI:

https://doi.org/10.5055/jom.2010.0016

Keywords:

cancer, cancer pain, chronic pain, extension trial, opioid, oxymorphone

Abstract

Objective: To evaluate the long-term safety, tolerability, and effectiveness of oxymorphone extended release (ER) in patients with cancer-related pain.
Design: Post hoc analysis of two ≥1-year open-label extension studies.
Setting: Multiple US cancer treatment facilities.
Patients: Patients with cancer pain who had participated in two short-term crossover comparator trials of oxymorphone ER: one open-label and one doubleblind randomized.
Interventions: Patients who had been taking oxymorphone ER continued the dose established in the previous study. Patients who had been taking a comparator opioid were switched to an equianalgesic dose of oxymorphone ER. All patients underwent individualized oxymorphone ER dose titration to optimize effectiveness and tolerability.
Assessments: Current, average, worst, and least pain scores were normalized to a 100-point scale. Patients rated treatment on a five-point global assessment of study medication (Poor = 1 to Excellent = 5). All adverse events (AEs) were recorded.
Results: Of the 80 patients who entered the extension trials, 26 completed 52 weeks, 7 discontinued owing to loss of effectiveness, and 20 discontinued owing to AEs, most of which were unrelated to study drug. No significant increase in mean (standard deviation [SD]) average pain intensity was observed from baseline (30.5 [19.6], 100-point scale) to final visit (35.9 [21.1], p = 0.37). The most common AEs were concomitant disease progression (28.8 percent, n = 23), nausea (22.5 percent, n = 18), dyspnea (16.3 percent, n = 13), fatigue (16.3 percent, n = 13), and edema of the lower limb (15 percent, n = 12).
Conclusions: In these patients with pain related to cancer, oxymorphone ER was generally well tolerated and provided stable long-term pain control.

Author Biographies

Neal E. Slatkin, MD

(Former) Director for the Department of Supportive Care, Pain & Palliative Medicine, City of Hope Medical Group (California Cancer Specialists Medical Group), Pasadena, California.

Michelle I. Rhiner, RN, MSN, NP

(Former) Director, Palliative Care Education, City of Hope National Medical Center, Duarte, California.

Errol M. Gould, PhD

Director, Medical Affairs, Endo Pharmaceuticals Inc., Chadds Ford, Pennsylvania.

Tina Ma, PhD

Director, Biostatistics, Endo Pharmaceuticals Inc., Chadds Ford, Pennsylvania.

Harry Ahdieh, PhD

(Former) Sr Director, Clinical R&D Affairs, Endo Pharmaceuticals Inc., Chadds Ford, Pennsylvania.

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