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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

Data Confirm Tapentadol Efficacy and Tolerability for Acute Pain Patients

RARITAN, N.J., May 26 /PRNewswire-USNewswire/ -- It is estimated that up to 30 percent of all people who have surgery experience gastrointestinal side effects, such as nausea and vomiting. The use of opioid pain medicines during and after surgery is a leading risk factor for experiencing these side effects. Nausea and vomiting are uncomfortable and bothersome and can have an impact on a patient's recovery.

According to a new Phase 3 clinical study published in the June 2009 issue of Current Medical Research and Opinion, and in an online version of the journal, tapentadol immediate release (IR) tablets provided patients with equivalent efficacy in pain relief following orthopedic surgery and significant reduction in nausea and/or vomiting compared to oxycodone IR.

Results from the new Phase 3 study of tapentadol IR tablets, a prescription oral analgesic approved by the U.S. Food and Drug Administration (FDA) in November 2008, showed that patients receiving 50-mg or 75-mg of the medication experienced significant relief of moderate to severe acute pain after a bunionectomy, one of the most common foot surgeries, compared with placebo. Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), Raritan, NJ, and Grunenthal GmbH, Aachen, Germany, supported this study.

The overall difference in the intensity of pain experienced by patients recovering from bunionectomy was examined during the first 12, 24, 48 and 72 hours after initiating treatment with tapentadol IR. Both tapentadol IR treatment groups showed a statistically significant improvement in pain compared to patients who received placebo, during all of these time periods (P <0.001), achieving both the primary efficacy endpoint of the sum of pain intensity difference (SPID) at 48 hours and secondary efficacy endpoints (SPID(12),
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SOURCE Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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