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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

Novel Pain Medicine Studied in Patients Following Bunionectomy

TAMPA, Fla., May 9 /PRNewswire-USNewswire/ -- Many foot-surgery patients experience intense pain for several days following removal of a bunion, one of the most common foot surgeries. The investigational pain medication tapentadol provided significant relief for patients who had this surgery, compared to those treated with placebo. Treatment with tapentadol also resulted in patients reporting fewer gastrointestinal side effects compared to those treated with an older, prescription pain reliever, researchers announced today.

Results from a Phase 3 clinical study of tapentadol immediate release (IR) tablets, a novel, investigational, centrally acting oral analgesic, showed that patients receiving 50 mg, 75 mg, or 100 mg of the medication experienced significant relief in acute pain after bunionectomy, a standard foot surgery associated with predictable levels of moderate to severe pain.

The overall difference in the intensity of pain experienced by patients recovering from bunionectomy was examined over the first 12, 24, 48 and 72 hours after initiating treatment with tapentadol. All tapentadol IR treatment groups showed a statistically significant improvement in pain over patients who received placebo, over all of these time periods (P<0.001).

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) presented these new data in a poster session at the 27th Annual Scientific Meeting of the American Pain Society (APS) in Tampa, Florida.

Treatment with 100 mg of tapentadol IR resulted in 79 percent of patients experiencing at least a 30 percent improvement in pain intensity at 48 hours. This is comparable to the 78 percent of patients who experienced the same percentage of improvement with 15 mg of oxycodone IR. Compared with placebo, the incidence of adverse events was higher for tapentadol IR and oxycodone IR treatment groups with a dose-
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SOURCE Johnson & Johnson Pharmaceutical Research & Development,L.L.C.
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