J&J's tapentadol improves GI tolerability

22 June 2008

Results from two Phase III clinical studies of US health care major Johnson & Johnson's tapentadol immediate-release tablets suggest significantly improved gastrointestinal tolerability as well as safety profile versus oxycodone HCl IR. The data were presented at the European League Against Rheumatism annual meeting in Paris, France.

The agent is a novel, centrally-acting analgesic that has two mechanisms of action, combining mu-opioid receptor agonism and noradrenaline reuptake inhibition in a single molecule. A study in patients with end-stage joint disease showed that treatment with 50mg or 75mg tapentadol IR resulted in significantly higher pain relief compared to placebo (p<0.001) when assessed over five days of treatment. In addition, patients treated with tapentadol experienced significantly fewer GI side effects compared to those given 10mg of oxycodone IR.

The 50mg and 75mg tapentadol IR treatment groups showed similar efficacy to that seen in patients treated with 10mg of oxycodone HCl IR.

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