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New Data From Phase 3 Study Suggests Tapentadol Immediate Release Effective for Acute Pain From Common Foot Surgery
Date:5/9/2008

dependent pattern of increasing adverse events. The most common treatment emergent adverse events in both active treatment groups included nausea, vomiting, constipation, dizziness, and somnolence (drowsiness).

However, the overall incidence of gastrointestinal side effects was lower at all three tapentadol IR doses than with 15 mg of oxycodone IR: tapentadol IR 50 mg at 46 percent, 75 mg at 46 percent, and 100 mg at 59 percent versus oxycodone IR 15 mg at 73 percent.

"This Phase 3 study has shown that all three doses of tapentadol IR were effective in providing analgesic relief of moderate to severe pain. Tapentadol patients reported a reduced incidence of some gastrointestinal side effects in comparison with a comparable dose of oxycodone, a standard pain treatment," said lead study author Charles Oh, M.D., Director, J&JPRD. "We are encouraged by these results and are eager to continue to study tapentadol as a novel acute pain treatment option."

Tapentadol has a unique profile with two mechanisms of action, combining mu-opioid receptor agonism and norepinephrine reuptake inhibition in a single molecule. It is being developed in immediate-release formulation for acute pain and extended-release formulation for chronic pain.

Acute pain is viewed as a complex, unpleasant experience with emotional and cognitive, as well as sensory features that occur in response to tissue trauma and is one of the most common reasons why patients seek medical attention. Common sources of acute pain include trauma, surgery, labor, medical procedures, and acute disease states. According to the American Pain Foundation, more than 25 million Americans experience acute pain each year as a result of injuries or surgeries.

The use of tapentadol IR for the treatment of moderate to severe acute pain is under review by the United States Food and Drug Administration. The New Drug Application (NDA) was filed on January 23, 2008. Upon FDA approval, PriCar
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SOURCE Johnson & Johnson Pharmaceutical Research & Development,L.L.C.
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