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FDA Approves Tapentadol for Relief of Moderate to Severe Acute Pain
NEW YORK -- November 21, 2008 -- The US Food and Drug Administration (FDA) has approved tapentadol immediate-release tablets for the relief of moderate to severe acute pain in adults aged 18 years or older.
The approval was based on data from multiple phase 3 trials involving more than 2,100 patients. The studies showed that tapentadol provided significant relief of moderate to severe acute pain when compared with placebo. The medicine was also generally well tolerated.
The studies were conducted in different patient groups, including those who had a bunionectomy, those with pain from end-stage joint disease, and in patients with low back pain or pain from osteoarthritis of the hip or knee.
SOURCE: Johnson & Johnson
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