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FDA Approves Tapentadol Immediate-Release Tablets for Relief of Moderate to Severe Acute Pain
Date:11/21/2008

RARITAN, N.J., Nov. 21 /PRNewswire/ -- Millions of Americans with moderate to severe acute pain and their health-care providers will soon have a new treatment option. Today, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., (J&JPRD), announced that the U.S. Food and Drug Administration (FDA) approved tapentadol immediate-release tablets for the relief of moderate to severe acute pain in adults 18 years of age or older.

Tapentadol is a new centrally acting oral analgesic. It has two mechanisms of action, combining mu-opioid receptor agonism and norepinephrine reuptake inhibition.

Tapentadol tablets have been approved in 50 mg, 75 mg and 100 mg doses.

The approval was based on data from clinical studies involving more than 2,100 patients. The studies, which were presented at the 27th Annual Scientific Meeting of the American Pain Society earlier this year, showed that tapentadol provided significant relief of moderate to severe acute pain compared to placebo.

Following today's FDA approval, and as per Federal regulation for all controlled substances, tapentadol will be reviewed by the U.S. Drug Enforcement Agency for scheduling, and it cannot be sold until it receives a scheduling classification.

A trade name for tapentadol has not yet been determined.

"We are pleased with the FDA's approval today. Tapentadol represents a new treatment option in pain management, and I am excited that we are able to bring this new choice to patients who are suffering from pain," said Joanne Waldstreicher, M.D., Global Head, Research and Development for CNS/Internal Medicine, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

More than 25 million Americans experience acute pain each year as a result of injuries or surgery, and it is the most common reason people seek medical attenti
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SOURCE Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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