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Tapentadol Performs as Well as Oxycodone in Osteoarthritis of the Knee: Presented at AAPM

By Ed Susman

KISSIMMEE, FL -- February 18, 2008 -- Tapentadol, an experimental extended-release mu-receptor agonist/noradrenaline reuptake inhibitor, was comparable with oxycodone in relieving pain due to osteoarthritis of the knee when administered at a 200-mg dose.

In the phase 2b, randomised, placebo-controlled dose-ranging trial, doctors found that in addition to comparable efficacy, treatment with tapentadol 200 mg resulted in fewer adverse events compared with oxycodone.

"There is a need for an effective, centrally acting analgesic with a more favourable tolerability profile than current treatment options for moderate to severe pain due to osteoarthritis," said Christine Rauschkolb-Loeffler, MD, PhD, Senior Director and Team Leader for Compound Development, Johnson & Johnson Pharmaceutical Research & Development, LLC, Titusville, New Jersey, United States.

Dr. Rauschkolb-Loeffler reported the findings on February 15 here at the American Academy of Pain Medicine (AAPM) 24th Annual Meeting.

Dr. Rauschkolb-Loeffler and colleagues enrolled 670 patients and randomly assigned them to 1 of 4 treatment groups: 162 patients received tapentadol 100 mg, 167 patients received tapentadol 200 mg, 169 patients received oxycodone 10 mg, and 167 patients were assigned to placebo.

"More physicians rated treatment with tapentadol extended release 100 mg and tapentadol extended release 200 mg as 'good,' 'very good,' or 'excellent' compared with placebo," she said. She noted that 62.2% of physicians gave these ratings to the 100-mg dose, 67% gave them to the 200-mg dose, and 49.7% gave the ratings to placebo.

The distribution of the Subject Global Assessment scores at the first visit was statistically significant, favouring the tapentadol extended-release 200-mg dose. About 70% of patients receiving tapentadol 200 mg rated their pain relief as "good or better" compared with about 50% of placebo patients (P < .001).

Gastrointestinal adverse events were reported among 56% of patients on oxycodone, 49% of patients on tapentadol 200 mg, 30% of patients on tapentadol 100 mg, and 23% of placebo patients.

Johnson & Johnson applied for approval of tapentadol immediate release in January with the United States Food and Drug Administration. Funding for this study was provided by Johnson & Johnson and by Grunenthal GmbH.


[Presentation title: Tapentadol Extended Release (ER) for the Relief of Moderate-to-Severe Chronic Pain Due to Osteoarthritis of the Knee. Abstract 159]

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