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FDA Approves New Drug to Alleviate Moderate to Severe Pain

November 25, 2008 -- The U.S. Food and Drug Administration has approved Tapentadol hydrochloride, an immediate-release oral tablet for the relief of moderate to severe acute pain.

Tapentadol is a centrally-acting synthetic analgesic that is available in doses of 50 mg, 75 mg, or 100 mg.

"This approval offers health care professionals an additional choice for treating moderate to severe acute pain," said John Jenkins, M.D., director of the office of new drugs in the FDA's Center for Drug Evaluation and Research.

Tapentadol acts in two ways, opioid (narcotic) and non-opioid. It affects the brain and body primarily by activating opioid receptors in the brain, spinal cord and gastrointestinal tract. In addition, Tapentadol inhibits the reuptake of the brain chemical norepinephrine which possibly has an analgesic effect.

Acute pain is a symptom of many medical conditions and can significantly interfere with a person's quality of life and general functioning. Opioids are considered safe and effective in selected patients but can cause dependence, abuse, and addiction. All patients treated with opioids require careful monitoring by their health care professional for signs of abuse and addiction, and to determine when opioid analgesics are no longer needed.

The most common side effects from Tapentadol are nausea, dizziness, vomiting, sleepiness, and headaches. The labeling for Tapentadol includes warnings about the risk of respiratory depression; addictive depressive effects on the central nervous system when taken with alcohol, other opioids, or illicit drugs; and abuse potential.

Tapentadol is manufactured by Johnson & Johnson, New Brunswick, N.J.

Source: Food and Drug Administration

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