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New Study Suggests Tapentadol IR for Acute Pain Is Associated With Improved Gastrointestinal Tolerability Compared to Oxycodone IR
Date:5/9/2008

TAMPA, Fla., May 9 /PRNewswire-USNewswire/ -- Many strong acting pain medications have bothersome side effects. These can include nausea and vomiting with short-term use, and constipation with longer, chronic use. Such symptoms can lead patients to discontinue treatment, adding additional complications to pain management for physicians. The novel investigational medication tapentadol, a centrally acting oral analgesic, provided pain relief for patients with fewer gastrointestinal side effects than those treated with an older, prescription pain reliever, researchers announced today.

Data from a new Phase 3 clinical study of tapentadol immediate release (IR) tablets demonstrated that tapentadol has a significantly improved gastrointestinal tolerability compared with oxycodone IR for treatment of acute pain and was well-tolerated when taken for up to 90 days.

These new data are being presented today in a poster session at the 27th Annual Scientific Meeting of the American Pain Society (APS) in Tampa, Florida. Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), Raritan, NJ, supported this study and its presentation.

In this study, patients with low back pain or pain from osteoarthritis of the knee or hip were treated with a flexible dose of 50 mg or 100 mg of tapentadol IR every four to six hours, up to a maximum of 600 mg/day, or a flexible dose of 10 mg or 15 mg of oxycodone IR every four to six hours, up to a maximum of 90 mg/day; patients were treated for up to 90 days. While both tapentadol IR and oxycodone IR offered pain relief, the tapentadol IR treatment group experienced a statistically significantly lower incidence of nausea, vomiting, constipation and composite nausea/vomiting (P<0.001) for all treatment comparisons. Overall, the percentage of patients with treatment emergent adverse events in the tapentadol IR group, at 76 percent, was lower than the percentage in the oxycodone IR group at 83 percent.
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SOURCE Johnson & Johnson Pharmaceutical Research & Development,L.L.C.
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