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| |  Extended Release Tapentadol More Effective for Low Back Pain Than Oxycodone, Placebo: Presented at APS By Ed Susman SAN DIEGO -- May 13, 2009 -- Treatment of chronic low back pain with the experimental extended release formulation of tapentadol appears to offer more effective symptom relief than controlled-release oxycodone or placebo, researchers said here at the 28th Annual Scientific Meeting of the American Pain Society (APS). "The number of patients reporting a 30% or greater improvement in average pain or a 50% or greater improvement in average pain was significantly higher with extended release tapentadol than with placebo," said Mila Etropolski, MD, Chronic Pain Product Development, Johnson&Johnson Pharmaceutical Research and Development, Raritan, New Jersey. "Tapentadol extended release had a better tolerability profile and was associated with a lower rate of treatment discontinuations than controlled release oxycodone," she added at a poster presentation on May 8. In the phase 3 study, researchers enrolled 981 patients and reported on outcomes involving 958 patients who were evaluable for efficacy. About 58% of the patients were female and about 85% were aged younger than 65 years. At baseline, about 88% of the patients were reporting severe pain -- scores of 6 or greater on a 0 to 19 numerical rating scale. By week 12, about 42% of patients on tapentadol 50-100 mg twice a day were able to achieve a reduction in pain of at least 30% compared with about 30% of patients taking oxycodone 10 to 20 mg twice a day, and about 27% of patients taking placebo (P < .001). The difference between oxycodone and placebo did not reach statistical significance (P = .365). By week 12, about 30% of patients on tapentadol were able to achieve a reduction in pain of at least 50% compared with about 22% of patients taking oxycodone and about 20% of patients taking placebo (P < .016). The difference between oxycodone and placebo did not reach statistical significance (P = .174). About 4.4% of the 319 patients on placebo experienced treatment-related side effects that led to discontinuation; about 16.7% of the 318 tapentadol-treated patients experienced treatment-related side effects that led to discontinuation compared with about 31.7% of the 328 oxycodone-treated patients. "Efficacy results for extended-release tapentadol were more robust than controlled-release oxycodone," Dr. Etropolski said. "More conservative imputation methods failed to show significant differences between controlled-release oxycodone and placebo because of the high rate of discontinuation in the oxycodone group, particularly early in the study before meaningful pain relief was achieved." Funding for this study was provided by Johnson&Johnson. [Presentation title: A Randomized, Double-Blind, Placebo- and Active-Controlled Phase 3 Study of Tapentadol ER for Chronic Low Back Pain: Analysis of Efficacy Endpoint Sensitivity. Abstract 235]
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