A randomized, open-label study of once-a-day AVINZA® (morphine sulfate extended-release capsules) versus twice-a-day OxyContin® (oxycodone hydrochloride controlled-release tablets) for chronic low back pain: The extension phase of the ACTION trial

Richard L. Rauck, MD; Stephen A. Bookbinder, MD; Timothy R. Bunker, MD; Christopher D. Alftine, MD; Richard Ghalie, MD; Andres Negro-Vilar, MD, PhD; Egbert de Jong, MD; Steven Gershon, MD

doi:10.5055/jom.2006.0048

Authors

Richard L. Rauck, MD
Stephen A. Bookbinder, MD
Timothy R. Bunker, MD
Christopher D. Alftine, MD
Richard Ghalie, MD
Andres Negro-Vilar, MD, PhD
Egbert de Jong, MD
Steven Gershon, MD

DOI:

https://doi.org/10.5055/jom.2006.0048

Keywords:

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Abstract

Study design and objective: The ACTION ® trial, an open-label, randomized, multicenter, two-part study, compared the efficacy and safety of two sustained-release opioids (SROs), AVINZA (A-MQD), morphine sulfate extended-release capsules given once a day, and OxyContin® (O-ER), oxycodone modified-release tablets given twice a day, in subjects with chronic, moderate to severe low back pain. The first part of the study, the evaluation phase, was followed by an optional four-month extension phase aimed at evaluating the long-term stability of pain control, SRO dose, and quality of sleep.
Results: Three hundred and ninety-two subjects were enrolled in the study; 220 completed the evaluation phase, and 174 entered the extension phase. During the latter phase, subjects in the A-MQD group (n = 79) continued to report lower pain scores, better quality of sleep, lower daily morphine-equivalent doses (means of 86 mg versus 119 mg), and a comparable usage of ibuprofen compared to subjects in the O-ER group (n = 95). The incidence and severity of elicited opioid side effects were similar between the two groups.
Conclusions: Both study drugs resulted in significant pain relief and improved sleep in SRO-naive patients with chronic low back pain, and this outcome was attained with a stable daily SRO dose. In patients who completed opioid dose titration, AVINZA performed significantly better than OxyContin in reducing pain scores and improving sleep—with a lower morphine-equivalent daily dose—during both the evaluation and extension phases.

Author Biographies

Richard L. Rauck, MD

Carolinas Pain Institute, Winston-Salem, North Carolina.

Stephen A. Bookbinder, MD

Ocala Rheumatology Research Center, Ocala, Florida.

Timothy R. Bunker, MD

The Birmingham Pain Center, Birmingham, Alabama.

Christopher D. Alftine, MD

Medford Medical Clinic, Medford, Oregon.

Richard Ghalie, MD

Ligand Pharmaceuticals, Inc., San Diego, California.

Andres Negro-Vilar, MD, PhD

Ligand Pharmaceuticals, Inc., San Diego, California.

Egbert de Jong, MD

Organon Pharmaceuticals USA, Inc., Roseland, New Jersey.

Steven Gershon, MD

Advanced Pain Management and Rehabilitation PC, Virginia Beach, Virginia.

References

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Rauck RL, Bookbinder SA, Bunker TR, et al.: Once-daily AVINZA vs. twice-daily OxyContin in an open-label extension (Part II) of the ACTION trial for the treatment of chronic moderate to severe low back pain. J Pain. 2006; 7(4 Suppl 1): 6314.

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