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New Phase 3 Study of Tapentadol Immediate Release Tablets Published in Current Medical Research and Opinion Journal
Date:5/26/2009

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Treatment with 50-mg or 75-mg of tapentadol IR resulted in 77.5 percent and 76 percent of patients, respectively, experiencing at least a 30 percent improvement in pain intensity at 48 hours. This is comparable to the 75 percent of patients who experienced the same percentage of improvement with 10-mg of oxycodone IR. Results were similar for patients who experienced a 50 percent improvement in pain intensity at 48 hours: 65 percent in the tapentadol IR 50-mg group, 64 percent in the tapentadol IR 75-mg group and 64 percent in the oxycodone IR 10-mg group.

The most common treatment-emergent adverse events in all active treatment groups included nausea, vomiting, dizziness, headache, somnolence (drowsiness) and constipation. Compared to oxycodone IR, the incidence of nausea and/or vomiting was significantly lower with tapentadol IR 50-mg: 35 percent compared to 59 percent respectively (P <0.001). In addition, the percentage of patients who experienced nausea and/or vomiting in the tapentadol IR 75-mg group was slightly lower than the oxycodone 10-mg group: 51 percent versus 59 percent (P=0.057).

"We are encouraged by this Phase 3 study because it shows that patients treated with tapentadol IR experienced effective analgesic relief of moderate to severe acute pain with fewer incidences of nausea and/or vomiting compared with a comparable dose of oxycodone IR, a standard pain treatment," said lead study author David Upmalis, M.D., Senior Director, J&JPRD. "Side effects are an important consideration in pain management. If healthcare professionals have a treatment option that offers the possibility for fewer side effects, it could lead to better patient outcomes."

On November 20, 2008, the FDA approved tapentadol immediate release tablets for the relief of moderate to severe acute pain in patients 18 years of age or older. Tapentadol IR tablets have been approved
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SOURCE Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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